Trial Outcomes & Findings for Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (NCT NCT03499353)

Results Overview

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current American Joint Committee on Cancer \[AJCC\] staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Results posted on

2021-11-09

Participant Flow

A total of 61 participants were enrolled and treated with talazoparib.

Participant milestones

Participant milestones
Measure	Talazoparib 1 mg QD During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Treatment STARTED	61
Treatment COMPLETED	45
Treatment NOT COMPLETED	16
Safety Follow-up STARTED	49
Safety Follow-up Received Treatment	0
Safety Follow-up COMPLETED	49
Safety Follow-up NOT COMPLETED	0
Long-Term Follow-up STARTED	58
Long-Term Follow-up Received Treatment	0
Long-Term Follow-up COMPLETED	0
Long-Term Follow-up NOT COMPLETED	58

Reasons for withdrawal

Reasons for withdrawal
Measure	Talazoparib 1 mg QD During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Treatment Adverse Event	3
Treatment Progressive Disease	10
Treatment Other	1
Treatment Withdrawal by Subject	2
Long-Term Follow-up Death	2
Long-Term Follow-up Study Terminated By Sponsor	55
Long-Term Follow-up Withdrawal by Subject	1

Baseline Characteristics

Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Age, Continuous Mean	44.6 Years STANDARD_DEVIATION 12.7 • n=5 Participants
Age, Customized 18-44 Years	37 Participants n=5 Participants
Age, Customized 45-64 Years	18 Participants n=5 Participants
Age, Customized >=65 Years	6 Participants n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	47 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	3 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	1 Participants n=5 Participants
Race/Ethnicity, Customized African American	7 Participants n=5 Participants
Race/Ethnicity, Customized Ashkenazi Jew	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	49 Participants n=5 Participants
Number of Participants with Triple Negative Breast Cancer (TNBC) at Baseline	61 Participants n=5 Participants
Duration of Breast Cancer at Baseline	3.57 Weeks n=5 Participants
Number of Participants with Breast Cancer Gene 1/2 (BRCA1/2) Mutations at Baseline BRCA1	48 Participants n=5 Participants
Number of Participants with Breast Cancer Gene 1/2 (BRCA1/2) Mutations at Baseline BRCA2	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current American Joint Committee on Cancer \[AJCC\] staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=48 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants Achieving Pathological Complete Response (pCR) as Per Independent Central Review (ICR) in Evaluable Analysis Set as Per ICR With 80% Confidence Interval (CI)	45.8 Percentage of participants Interval 36.42 to 55.22

PRIMARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=48 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants Achieving pCR as Per ICR in Evaluable Analysis Set as Per ICR With 95% CI	45.8 Percentage of participants Interval 31.98 to 60.62

SECONDARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants who received any amount of talazoparib.

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants Achieving pCR as Per ICR in Intention-to-Treat (ITT) Analysis Set With 80% CI	49.2 Percentage of participants Interval 40.97 to 57.39

SECONDARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants who received any amount of talazoparib.

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants Achieving pCR as Per ICR in ITT Analysis Set With 95% CI	49.2 Percentage of participants Interval 36.7 to 61.63

SECONDARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants enrolled who received at least 80% of the talazoparib dose prescribed at treatment start (1 mg/day, except participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by investigator, as well as participants who progressed or died before pCR could be assessed by investigator (these participants were considered as non-responders).

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=48 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants Achieving pCR as Per Investigator in Evaluable Analysis Set as Per Investigator	45.8 Percentage of participants Interval 31.98 to 60.62

SECONDARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants who received any amount of talazoparib.

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants Achieving pCR as Per Investigator in ITT Analysis Set	47.5 Percentage of participants Interval 35.03 to 60.09

SECONDARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants enrolled who received at least 80% of the talazoparib dose prescribed at treatment start (1 mg/day, except participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by investigator, as well as participants who progressed or died before pCR could be assessed by investigator (these participants were considered as non-responders).

pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=48 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants Achieving pCR in Breast Only as Per Investigator in Evaluable Analysis Set as Per Investigator	45.8 Percentage of participants Interval 31.98 to 60.62

SECONDARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants who received any amount of talazoparib.

pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants Achieving pCR in Breast Only as Per Investigator in ITT Analysis Set	47.5 Percentage of participants Interval 35.03 to 60.09

SECONDARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).

pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=48 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants Achieving pCR in Breast Only as Per ICR in Evaluable Analysis Set as Per ICR	47.9 Percentage of participants Interval 34.11 to 62.75

SECONDARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants who received any amount of talazoparib.

pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants Achieving pCR in Breast Only as Per ICR in ITT Analysis Set	50.8 Percentage of participants Interval 38.37 to 63.3

SECONDARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).

The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=48 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR Missing (Participants who had progressive disease or with missing required axillary specimen)	22.9 Percentage of participants Interval 11.2 to 41.2
Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR RCB - 0	45.8 Percentage of participants Interval 29.0 to 63.7
Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR RCB - I	0.0 Percentage of participants Interval 0.0 to 12.1
Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR RCB - II	31.3 Percentage of participants Interval 17.2 to 49.8
Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR RCB - III	0.0 Percentage of participants Interval 0.0 to 12.1

SECONDARY outcome

Timeframe: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Population: The analysis population included all participants who received any amount of talazoparib

The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Percentage of Participants With RCB as Per ICR in ITT Analysis Set RCB - 0	49.2 Percentage of participants Interval 33.6 to 64.9
Percentage of Participants With RCB as Per ICR in ITT Analysis Set RCB - I	1.6 Percentage of participants Interval 0.2 to 12.6
Percentage of Participants With RCB as Per ICR in ITT Analysis Set RCB - II	27.9 Percentage of participants Interval 15.8 to 44.2
Percentage of Participants With RCB as Per ICR in ITT Analysis Set RCB - III	0.0 Percentage of participants Interval 0.0 to 9.8
Percentage of Participants With RCB as Per ICR in ITT Analysis Set Missing (Participants who had progressive disease or with missing required axillary specimen)	21.3 Percentage of participants Interval 11.0 to 37.3

SECONDARY outcome

Timeframe: 3 years after surgery

Population: The analysis population included all participants enrolled who received at least 80% of the dose prescribed at treatment start (1 mg/day, except those with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment, and participants who progressed or died before pCR could be assessed. EFS at 3 years was not analyzed as the 3-year threshold was not reached at study termination, therefore number of participants analyzed was 0.

Event-Free Survival (EFS) is defined as the time from surgery date to first documentation of local or distant recurrence or death or initiation of antineoplastic therapy before documentation of first relapse. Participants discontinuing study before documentation of first relapse or death, but after surgery were censored observations for EFS. EFS at 3 years is defined as the probability of being event free at 3 years after surgery using Kaplan Meier methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years after first dose of talazoparib

Population: The analysis population included all participants enrolled who received at least 80% of the dose prescribed at treatment start (1 mg/day, except those with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment, and participants who progressed or died before pCR could be assessed. OS at 3 years was not analyzed as the 3-year threshold was not reached at study termination, therefore number of participants analyzed was 0.

Overall Survival (OS) is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years after first dose of talazoparib

Population: The analysis population included all participants who received any amount of talazoparib. OS at 3 years was not analyzed as no participants had yet reached the 3-year threshold when the study was terminated, therefore the number of participants analyzed for this outcome measure was 0.

OS is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Population: The analysis population included all participants who received any amount of talazoparib.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or worsened relative to pretreatment state. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) All-causality Grade 3 or 4 TEAEs	29 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) All-causality Grade 5 TEAEs	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) All-causality TEAEs	60 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Treatment-related TEAEs	58 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Treatment-related Grade 3 or 4 TEAEs	27 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Treatment-related Grade 5 TEAEs	0 Participants

SECONDARY outcome

Timeframe: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Population: The analysis population included all participants who received any amount of talazoparib.

An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With Serious Adverse Events (SAEs) All-causality SAEs	11 Participants
Number of Participants With Serious Adverse Events (SAEs) Treatment-related SAEs	9 Participants

SECONDARY outcome

Timeframe: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Population: The analysis population included all participants who received any amount of talazoparib.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Drug All-causality TEAEs	3 Participants
Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Drug Treatment-related TEAEs	3 Participants

SECONDARY outcome

Timeframe: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Population: The analysis population included all participants who received any amount of talazoparib.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With TEAEs Leading to Temporary Discontinuation of Study Drug All-causality TEAEs	20 Participants
Number of Participants With TEAEs Leading to Temporary Discontinuation of Study Drug Treatment-related TEAEs	19 Participants

SECONDARY outcome

Timeframe: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Population: The analysis population included all participants who received any amount of talazoparib.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With TEAEs Leading to Dose Reduction of Study Drug All-causality TEAEs	24 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Study Drug Treatment-related TEAEs	24 Participants

SECONDARY outcome

Timeframe: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Population: The analysis population included all participants who received any amount of talazoparib. Number of participants analyzed refers to number of participants evaluable for this outcome measure. Number analyzed refers to total number of participants with at least 1 observation of the given laboratory test.

Laboratory parameters included hematology, serum chemistry, urinalysis and coagulation. Grades of laboratory abnormalities were defined according to NCI CTCAE version 4.03. Participants with laboratory test abnormalities meeting specified criteria (\>upper limit of normal \[ULN\] or \<lower limit of normal \[LLN\]) (without regards to baseline abnormality) are reported.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With Laboratory Abnormalities Erythrocyte Mean Corpuscular Volume >ULN	33 Participants
Number of Participants With Laboratory Abnormalities Erythrocytes <LLN	38 Participants
Number of Participants With Laboratory Abnormalities Hematocrit <LLN	39 Participants
Number of Participants With Laboratory Abnormalities Blood urea nitrogen >ULN	3 Participants
Number of Participants With Laboratory Abnormalities Prothrombin Time <LLN	2 Participants
Number of Participants With Laboratory Abnormalities Erythrocyte Mean Corpuscular Volume <LLN	1 Participants
Number of Participants With Laboratory Abnormalities Lactate dehydrogenase >ULN	8 Participants
Number of Participants With Laboratory Abnormalities Protein <LLN	5 Participants
Number of Participants With Laboratory Abnormalities Protein >ULN	2 Participants

SECONDARY outcome

Timeframe: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Population: The analysis population included all participants who received any amount of talazoparib. Number of participants analyzed refers to number of participants evaluable for this outcome measure. Number analyzed refers to total number of participants who had on-study laboratory test values that were applicable for the assessment of the laboratory results of interest.

Hematology laboratory parameters included hematocrit, hemoglobin, mean corpuscular volume, red blood cells, platelets, white blood cells with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Grades of lab results were defined by NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. This outcome measure was based only on laboratory data. As Grade 4 anemia cannot be assessed based only on laboratory data, it was not applicable for analysis in this outcome measure.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Lymphocyte count decreased Grade 1 to Grade 3	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Lymphocyte count decreased Grade 2 to Grade 3	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Lymphocyte count decreased Grade 0 to Grade 4	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Lymphocyte count decreased Grade 1 to Grade 4	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Lymphocyte count decreased Grade 2 to Grade 4	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Neutrophil count decreased Grade 0 to Grade 3	3 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Neutrophil count decreased Grade 0 to Grade 4	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Neutrophil count decreased Grade 2 to Grade 3	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Neutrophil count decreased Grade 2 to Grade 4	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline White blood cell decreased Grade 0 to Grade 3	1 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline White blood cell decreased Grade 0 to Grade 4	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline White blood cell decreased Grade 1 to Grade 3	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline White blood cell decreased Grade 1 to Grade 4	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline White blood cell decreased Grade 2 to Grade 3	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline White blood cell decreased Grade 2 to Grade 4	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Anemia Grade 0 to Grade 3	7 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Anemia Grade 1 to Grade 3	1 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Anemia Grade 2 to Grade 3	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Lymphocyte count decreased Grade 0 to Grade 3	1 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Neutrophil count decreased Grade 1 to Grade 3	0 Participants
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Neutrophil count decreased Grade 1 to Grade 4	0 Participants

SECONDARY outcome

Timeframe: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Population: The analysis population included all participants who received any amount of talazoparib.

Chemistry laboratory parameters included albumin, total protein, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, creatinine, non-fasting glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and lactate dehydrogenase. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 1 (Mild) = asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 (Moderate ) = minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4 = events with life-threatening consequences, urgent intervention indicated; Grade 5 = death related to AE.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hyperglycemia Baseline grade not reported to Grade 3	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hyperglycemia Baseline grade not reported to Grade 4	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hyperglycemia Grade 0 to Grade 3	1 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hyperglycemia Grade 0 to Grade 4	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hyperglycemia Grade 1 to Grade 3	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hypophosphatemia Baseline grade not reported to Grade 4	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hypophosphatemia Grade 0 to Grade 4	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hyperglycemia Grade 1 to Grade 4	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hyperglycemia Grade 2 to Grade 3	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hyperglycemia Grade 2 to Grade 4	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hypophosphatemia Baseline grade not reported to Grade 3	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hypophosphatemia Grade 0 to Grade 3	1 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hypophosphatemia Grade 1 to Grade 3	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hypophosphatemia Grade 1 to Grade 4	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hypophosphatemia Grade 2 to Grade 3	0 Participants
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline Hypophosphatemia Grade 2 to Grade 4	0 Participants

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 2, 3, 4

Population: The analysis population included all participants treated with talazoparib with drug plasma concentration results from at least 1 visit. Number of participants analyzed=number of participants evaluable for this outcome measure. Number analyzed=number of participants evaluable for each time point.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Trough Plasma Concentration (Ctrough) of Talazoparib in Cycles 2, 3 and 4 in PK Analysis Set Cycle 3	4699 picograms per milliliter (pg/mL) Geometric Coefficient of Variation 119.9
Trough Plasma Concentration (Ctrough) of Talazoparib in Cycles 2, 3 and 4 in PK Analysis Set Cycle 4	4198 picograms per milliliter (pg/mL) Geometric Coefficient of Variation 139.8
Trough Plasma Concentration (Ctrough) of Talazoparib in Cycles 2, 3 and 4 in PK Analysis Set Cycle 2	4703 picograms per milliliter (pg/mL) Geometric Coefficient of Variation 71.5

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 2, 3, 4

Population: The analysis population included all participants treated with talazoparib for whom drug plasma concentration results from at least 1 visit were available.

Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=61 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Within-Participant Average Ctrough of Talazoparib at Steady State in PK Analysis Set	4525 pg/mL Geometric Coefficient of Variation 109.5

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 2, 3, 4

Population: The analysis population included all participants treated with talazoparib with drug plasma concentration results from at least 1 visit who had received 21 consecutive days of dosing without interruption prior to sample collection. Actual sample collection times were used to determine whether a pre-dose PK sample was dose-compliant. Number of participants analyzed=number of participants evaluable for this outcome measure. Number analyzed=number of participants evaluable for each time point.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Ctrough of Talazoparib in Cycles 2, 3 and 4 in Dose-Compliant PK Analysis Set Cycle 2	5241 pg/mL Geometric Coefficient of Variation 57.9
Ctrough of Talazoparib in Cycles 2, 3 and 4 in Dose-Compliant PK Analysis Set Cycle 3	5208 pg/mL Geometric Coefficient of Variation 53.8
Ctrough of Talazoparib in Cycles 2, 3 and 4 in Dose-Compliant PK Analysis Set Cycle 4	4537 pg/mL Geometric Coefficient of Variation 84.6

SECONDARY outcome

Timeframe: Pre-dosing on Day 1 of Cycles 2, 3, 4

Population: The analysis population included all participants treated with talazoparib with drug plasma concentration results from at least 1 visit who had received 21 consecutive days of dosing without interruption prior to sample collection. Actual sample collection times were used to determine whether a pre-dose PK sample was dose-compliant.

Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Within-Participant Average Ctrough of Talazoparib at Steady State in Dose-Compliant PK Analysis Set	5001 pg/mL Geometric Coefficient of Variation 65.2

SECONDARY outcome

Timeframe: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Population: The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes (PROs), consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants Who Achieved Definitive Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Per European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-30)	19 Participants

SECONDARY outcome

Timeframe: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Population: The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Kaplan-Meier Estimate of Time to Definitive Deterioration in GHS/QoL Per EORTC QLQ-30	NA Months Interval 4.6 to The median time to definitive deterioration in GHS/QoL and the upper limit of its 95% confidence interval were not estimable as there was insufficient number of participants with definitive deterioration.

SECONDARY outcome

Timeframe: 3 months and 6 months post-baseline

Population: The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using the Kaplan Meier method were reported.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Probability of Not Achieving Definitive Deterioration in GHS/QoL Per EORTC QLQ-C30 at 3 and 6 Months 3 months	0.696 Probability of being event-free Interval 0.547 to 0.805
Probability of Not Achieving Definitive Deterioration in GHS/QoL Per EORTC QLQ-C30 at 3 and 6 Months 6 months	0.594 Probability of being event-free Interval 0.435 to 0.721

SECONDARY outcome

Timeframe: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Population: The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent \<10 point increase.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants Who Achieved Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30	9 Participants

SECONDARY outcome

Timeframe: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Population: The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent \<10 point increase.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Kaplan-Meier Estimate of Time to Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30	NA Months The median time to definitive deterioration in nausea and vomiting symptoms and its 95% confidence interval were not estimable as there was insufficient number of participants with definitive deterioration.

SECONDARY outcome

Timeframe: 3 months and 6 months post-baseline

Population: The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, with 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores (1=very poor to 7=excellent); other items have 4 possible scores (1=not at all to 4=very much). For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A linear transformation was applied to raw scores so that transformed scores lie between 0 to 100, with 0 being the best and 100 being the worst for this symptom scale. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as≥10 point increase from baseline without any subsequent \<10 point increase. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using Kaplan Meier method were reported.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Probability of Not Achieving Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 at 3 and 6 Months 3 months	0.863 Probability of being event-free Interval 0.734 to 0.932
Probability of Not Achieving Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 at 3 and 6 Months 6 months	0.818 Probability of being event-free Interval 0.678 to 0.901

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. Negative change from baseline indicates deterioration in GHS/QoL and positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Global QoL Per EORTC QLQ-C30 Cycle 2 Day 15	-5.3 Units on a scale Interval -9.36 to -1.25
Change From Baseline in Global QoL Per EORTC QLQ-C30 Cycle 6 Day 1	-11.3 Units on a scale Interval -17.17 to -5.41
Change From Baseline in Global QoL Per EORTC QLQ-C30 Cycle 1 Day 15	-6.0 Units on a scale Interval -10.43 to -1.59
Change From Baseline in Global QoL Per EORTC QLQ-C30 Cycle 2 Day 1	-7.4 Units on a scale Interval -11.98 to -2.87
Change From Baseline in Global QoL Per EORTC QLQ-C30 Cycle 3 Day 1	-9.1 Units on a scale Interval -14.7 to -3.42
Change From Baseline in Global QoL Per EORTC QLQ-C30 Cycle 4 Day 1	-10.3 Units on a scale Interval -15.14 to -5.4
Change From Baseline in Global QoL Per EORTC QLQ-C30 Cycle 5 Day 1	-13.0 Units on a scale Interval -19.29 to -6.78
Change From Baseline in Global QoL Per EORTC QLQ-C30 End of treatment	-7.9 Units on a scale Interval -13.0 to -2.71
Change From Baseline in Global QoL Per EORTC QLQ-C30 Post-surgical follow-up	-13.3 Units on a scale Interval -19.64 to -7.02

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the physical functioning scale, participants self-rated levels of difficulty in doing strenuous activities, taking a walk, how much they needed to stay in bed or a chair, or needed help with eating, dressing, bathing, using the toilet. Negative change from baseline indicates deterioration in physical functioning and positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Physical Functioning Per EORTC QLQ-C30 Cycle 1 Day 15	-3.6 Units on a scale Interval -5.73 to -1.4
Change From Baseline in Physical Functioning Per EORTC QLQ-C30 Cycle 2 Day 1	-6.1 Units on a scale Interval -9.12 to -3.05
Change From Baseline in Physical Functioning Per EORTC QLQ-C30 Cycle 2 Day 15	-6.1 Units on a scale Interval -8.95 to -3.17
Change From Baseline in Physical Functioning Per EORTC QLQ-C30 Cycle 3 Day 1	-8.4 Units on a scale Interval -12.53 to -4.29
Change From Baseline in Physical Functioning Per EORTC QLQ-C30 Cycle 4 Day 1	-9.3 Units on a scale Interval -12.66 to -5.95
Change From Baseline in Physical Functioning Per EORTC QLQ-C30 Cycle 5 Day 1	-9.7 Units on a scale Interval -14.39 to -5.1
Change From Baseline in Physical Functioning Per EORTC QLQ-C30 Cycle 6 Day 1	-9.0 Units on a scale Interval -13.82 to -4.24
Change From Baseline in Physical Functioning Per EORTC QLQ-C30 End of treatment	-5.1 Units on a scale Interval -8.83 to -1.45
Change From Baseline in Physical Functioning Per EORTC QLQ-C30 Post-surgical follow-up	-14.2 Units on a scale Interval -21.16 to -7.28

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the role functioning scale, participants self-rated how much they were limited in doing work or daily activities, or in pursuing hobbies or other leisure time activities during the past week. Negative change from baseline values indicates deterioration in role functioning and positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Role Functioning Per EORTC QLQ-C30 Cycle 1 Day 15	-4.7 Units on a scale Interval -9.31 to 0.01
Change From Baseline in Role Functioning Per EORTC QLQ-C30 Cycle 2 Day 1	-9.4 Units on a scale Interval -14.71 to -4.14
Change From Baseline in Role Functioning Per EORTC QLQ-C30 Cycle 2 Day 15	-6.4 Units on a scale Interval -10.97 to -1.91
Change From Baseline in Role Functioning Per EORTC QLQ-C30 Cycle 3 Day 1	-10.9 Units on a scale Interval -18.04 to -3.7
Change From Baseline in Role Functioning Per EORTC QLQ-C30 Cycle 4 Day 1	-8.9 Units on a scale Interval -13.15 to -4.67
Change From Baseline in Role Functioning Per EORTC QLQ-C30 Cycle 5 Day 1	-9.4 Units on a scale Interval -15.94 to -2.87
Change From Baseline in Role Functioning Per EORTC QLQ-C30 Cycle 6 Day 1	-7.0 Units on a scale Interval -12.85 to -1.13
Change From Baseline in Role Functioning Per EORTC QLQ-C30 End of treatment	-4.8 Units on a scale Interval -10.9 to 1.38
Change From Baseline in Role Functioning Per EORTC QLQ-C30 Post-surgical follow-up	-21.7 Units on a scale Interval -31.49 to -11.84

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the emotional functioning scale, participants self-rated how much they felt tense, worried, irritable or depressed during the past week. Negative change from baseline values indicates deterioration in emotional functioning and positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Emotional Functioning Per EORTC QLQ-C30 Cycle 1 Day 15	2.9 Units on a scale Interval -2.1 to 7.91
Change From Baseline in Emotional Functioning Per EORTC QLQ-C30 Cycle 2 Day 1	0.4 Units on a scale Interval -4.39 to 5.11
Change From Baseline in Emotional Functioning Per EORTC QLQ-C30 Cycle 2 Day 15	1.3 Units on a scale Interval -3.74 to 6.39
Change From Baseline in Emotional Functioning Per EORTC QLQ-C30 Cycle 3 Day 1	-0.9 Units on a scale Interval -6.05 to 4.24
Change From Baseline in Emotional Functioning Per EORTC QLQ-C30 Cycle 4 Day 1	-4.8 Units on a scale Interval -9.47 to -0.22
Change From Baseline in Emotional Functioning Per EORTC QLQ-C30 Cycle 5 Day 1	-3.0 Units on a scale Interval -8.89 to 2.9
Change From Baseline in Emotional Functioning Per EORTC QLQ-C30 Cycle 6 Day 1	-7.8 Units on a scale Interval -14.54 to -1.06
Change From Baseline in Emotional Functioning Per EORTC QLQ-C30 End of treatment	-4.0 Units on a scale Interval -9.87 to 1.78
Change From Baseline in Emotional Functioning Per EORTC QLQ-C30 Post-surgical follow-up	-3.1 Units on a scale Interval -10.61 to 4.5

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the cognitive functioning scale, participants self-rated the extent of difficulty in concentrating on things or remembering things during the past week. Negative change from baseline values indicates deterioration in cognitive functioning and positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30 Cycle 1 Day 15	-2.3 Units on a scale Interval -7.02 to 2.37
Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30 Cycle 2 Day 1	-5.4 Units on a scale Interval -9.62 to -1.25
Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30 Cycle 2 Day 15	-5.3 Units on a scale Interval -9.78 to -0.83
Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30 Cycle 3 Day 1	-6.9 Units on a scale Interval -12.93 to -0.84
Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30 Cycle 4 Day 1	-9.7 Units on a scale Interval -15.64 to -3.74
Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30 Cycle 5 Day 1	-7.7 Units on a scale Interval -13.49 to -1.9
Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30 Cycle 6 Day 1	-9.7 Units on a scale Interval -17.69 to -1.66
Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30 End of treatment	-7.1 Units on a scale Interval -13.84 to -0.44
Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30 Post-surgical follow-up	-7.8 Units on a scale Interval -16.98 to 1.43

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the social functioning scale, participants self-rated how much their physical condition or medical treatment interfered with their family life and social activities during the past week. Negative change from baseline values indicates deterioration in social functioning and positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Social Functioning Per EORTC QLQ-C30 Cycle 1 Day 15	-2.3 Units on a scale Interval -8.62 to 3.96
Change From Baseline in Social Functioning Per EORTC QLQ-C30 Cycle 2 Day 1	-4.3 Units on a scale Interval -9.71 to 1.02
Change From Baseline in Social Functioning Per EORTC QLQ-C30 Cycle 2 Day 15	-1.9 Units on a scale Interval -7.16 to 3.37
Change From Baseline in Social Functioning Per EORTC QLQ-C30 Cycle 3 Day 1	-7.6 Units on a scale Interval -14.18 to -1.03
Change From Baseline in Social Functioning Per EORTC QLQ-C30 Cycle 4 Day 1	-5.4 Units on a scale Interval -10.0 to -0.85
Change From Baseline in Social Functioning Per EORTC QLQ-C30 Cycle 5 Day 1	-6.0 Units on a scale Interval -14.25 to 2.28
Change From Baseline in Social Functioning Per EORTC QLQ-C30 Cycle 6 Day 1	-8.1 Units on a scale Interval -15.45 to -0.68
Change From Baseline in Social Functioning Per EORTC QLQ-C30 End of treatment	-8.1 Units on a scale Interval -14.21 to -1.98
Change From Baseline in Social Functioning Per EORTC QLQ-C30 Post-surgical follow-up	-20.6 Units on a scale Interval -30.59 to -10.52

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the fatigue symptoms scale, participants self-rated how much they had felt weak, tired or needed to rest during the past week. Negative change from baseline values indicates improvement of fatigue symptoms and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30 Cycle 2 Day 1	18.4 Units on a scale Interval 12.7 to 24.02
Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30 Cycle 6 Day 1	20.4 Units on a scale Interval 12.41 to 28.45
Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30 Cycle 1 Day 15	16.3 Units on a scale Interval 9.98 to 22.58
Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30 Cycle 2 Day 15	17.4 Units on a scale Interval 11.58 to 23.27
Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30 Cycle 3 Day 1	21.0 Units on a scale Interval 13.88 to 28.15
Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30 Cycle 4 Day 1	22.2 Units on a scale Interval 16.74 to 27.71
Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30 Cycle 5 Day 1	21.7 Units on a scale Interval 14.45 to 28.85
Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30 End of treatment	14.3 Units on a scale Interval 7.32 to 21.25
Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30 Post-surgical follow-up	23.3 Units on a scale Interval 16.33 to 30.34

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. Negative change from baseline values indicates improvement of nausea and vomiting symptoms and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 Cycle 6 Day 1	7.5 Units on a scale Interval 2.83 to 12.22
Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 Cycle 1 Day 15	11.2 Units on a scale Interval 6.8 to 15.68
Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 Cycle 2 Day 1	8.0 Units on a scale Interval 4.4 to 11.55
Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 Cycle 2 Day 15	7.2 Units on a scale Interval 3.67 to 10.72
Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 Cycle 3 Day 1	5.4 Units on a scale Interval 1.97 to 8.9
Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 Cycle 4 Day 1	3.9 Units on a scale Interval 0.74 to 7.01
Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 Cycle 5 Day 1	4.3 Units on a scale Interval 1.06 to 7.49
Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 End of treatment	0.5 Units on a scale Interval -2.46 to 3.42
Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 Post-surgical follow-up	1.1 Units on a scale Interval -2.13 to 4.35

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the pain symptoms scale, participants self-rated the extent of pain and how much the pain interfered with daily activities during the past week. Negative change from baseline values indicates improvement of pain symptoms and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Pain Symptoms Per EORTC QLQ-C30 Cycle 1 Day 15	-1.9 Units on a scale Interval -6.01 to 2.13
Change From Baseline in Pain Symptoms Per EORTC QLQ-C30 Cycle 2 Day 1	-0.0 Units on a scale Interval -4.78 to 4.78
Change From Baseline in Pain Symptoms Per EORTC QLQ-C30 Cycle 2 Day 15	-1.5 Units on a scale Interval -6.5 to 3.47
Change From Baseline in Pain Symptoms Per EORTC QLQ-C30 Cycle 3 Day 1	0.7 Units on a scale Interval -4.99 to 6.44
Change From Baseline in Pain Symptoms Per EORTC QLQ-C30 Cycle 4 Day 1	-2.7 Units on a scale Interval -7.83 to 2.41
Change From Baseline in Pain Symptoms Per EORTC QLQ-C30 Cycle 5 Day 1	1.3 Units on a scale Interval -6.09 to 8.66
Change From Baseline in Pain Symptoms Per EORTC QLQ-C30 Cycle 6 Day 1	-1.1 Units on a scale Interval -7.76 to 5.61
Change From Baseline in Pain Symptoms Per EORTC QLQ-C30 End of treatment	1.4 Units on a scale Interval -4.36 to 7.22
Change From Baseline in Pain Symptoms Per EORTC QLQ-C30 Post-surgical follow-up	14.4 Units on a scale Interval 6.65 to 22.24

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the dyspnoea symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of dyspnoea symptoms and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30 Cycle 1 Day 15	-0.8 Units on a scale Interval -2.34 to 0.79
Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30 Cycle 2 Day 1	5.1 Units on a scale Interval 0.42 to 9.72
Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30 Cycle 2 Day 15	5.3 Units on a scale Interval 0.44 to 10.16
Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30 Cycle 3 Day 1	8.0 Units on a scale Interval 2.38 to 13.56
Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30 Cycle 4 Day 1	16.3 Units on a scale Interval 9.43 to 23.13
Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30 Cycle 5 Day 1	8.5 Units on a scale Interval 3.16 to 13.93
Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30 Cycle 6 Day 1	8.6 Units on a scale Interval 2.31 to 14.89
Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30 End of treatment	3.8 Units on a scale Interval -0.81 to 8.43
Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30 Post-surgical follow-up	4.4 Units on a scale Interval -2.67 to 11.56

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the insomnia symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of insomnia symptoms and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30 Cycle 1 Day 15	-4.7 Units on a scale Interval -12.59 to 3.29
Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30 Cycle 2 Day 1	-4.3 Units on a scale Interval -13.1 to 4.41
Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30 Cycle 2 Day 15	-10.6 Units on a scale Interval -18.72 to -2.49
Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30 Cycle 3 Day 1	-6.5 Units on a scale Interval -14.5 to 1.46
Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30 Cycle 4 Day 1	-7.0 Units on a scale Interval -15.52 to 1.56
Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30 Cycle 5 Day 1	-2.6 Units on a scale Interval -12.9 to 7.77
Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30 Cycle 6 Day 1	-6.5 Units on a scale Interval -18.85 to 5.94
Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30 End of treatment	-4.8 Units on a scale Interval -16.59 to 7.07
Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30 Post-surgical follow-up	1.1 Units on a scale Interval -13.68 to 15.9

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the appetite loss symptoms scale, participants self-rated the extent of lack of appetite during the past week. Negative change from baseline values indicates improvement of appetite loss symptoms and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30 Cycle 1 Day 15	10.1 Units on a scale Interval 2.47 to 17.68
Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30 Cycle 2 Day 1	3.6 Units on a scale Interval -3.37 to 10.62
Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30 Cycle 2 Day 15	0.8 Units on a scale Interval -6.32 to 7.84
Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30 Cycle 3 Day 1	5.8 Units on a scale Interval -2.63 to 14.22
Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30 Cycle 4 Day 1	3.1 Units on a scale Interval -3.91 to 10.11
Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30 Cycle 5 Day 1	4.3 Units on a scale Interval -3.64 to 12.18
Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30 Cycle 6 Day 1	4.3 Units on a scale Interval -4.48 to 13.09
Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30 End of treatment	1.9 Units on a scale Interval -4.87 to 8.67
Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30 Post-surgical follow-up	2.2 Units on a scale Interval -5.74 to 10.18

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the constipation symptoms scale, participants self-rated the intensity of constipation during the past week. Negative change from baseline values indicates improvement of constipation symptoms and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30 Cycle 1 Day 15	12.4 Units on a scale Interval 5.32 to 19.49
Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30 Cycle 2 Day 1	9.4 Units on a scale Interval 1.71 to 17.13
Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30 Cycle 2 Day 15	12.1 Units on a scale Interval 4.84 to 19.4
Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30 Cycle 3 Day 1	8.0 Units on a scale Interval 0.69 to 15.26
Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30 Cycle 4 Day 1	6.2 Units on a scale Interval -0.23 to 12.63
Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30 Cycle 5 Day 1	7.7 Units on a scale Interval 0.48 to 14.9
Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30 Cycle 6 Day 1	5.4 Units on a scale Interval -4.65 to 15.41
Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30 End of treatment	3.8 Units on a scale Interval -1.58 to 9.2
Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30 Post-surgical follow-up	3.3 Units on a scale Interval -4.9 to 11.57

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the diarrhea symptoms scale, participants self-rated the intensity of diarrhea during the past week. Negative change from baseline values indicates improvement of diarrhea symptoms and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30 Cycle 6 Day 1	0.0 Units on a scale Interval -4.46 to 4.46
Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30 End of treatment	1.9 Units on a scale Interval -0.79 to 4.6
Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30 Post--surgical follow-up	1.1 Units on a scale Interval -2.87 to 5.09
Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30 Cycle 1 Day 15	1.6 Units on a scale Interval -2.3 to 5.4
Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30 Cycle 2 Day 1	2.2 Units on a scale Interval -1.68 to 6.02
Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30 Cycle 2 Day 15	1.5 Units on a scale Interval -2.24 to 5.27
Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30 Cycle 3 Day 1	0.0 Units on a scale Interval -2.09 to 2.09
Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30 Cycle 4 Day 1	2.3 Units on a scale Interval -1.14 to 5.79
Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30 Cycle 5 Day 1	3.4 Units on a scale Interval -1.41 to 8.25

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the symptom scale of financial difficulties, participants self-rated how much their physical condition or medical treatment caused financial difficulties. Negative change from baseline values indicates improvement of financial difficulties and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=50 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Financial Difficulties Per EORTC QLQ-C30 Cycle 1 Day 15	-3.9 Units on a scale Interval -8.47 to 0.72
Change From Baseline in Financial Difficulties Per EORTC QLQ-C30 Cycle 2 Day 1	-1.4 Units on a scale Interval -9.52 to 6.62
Change From Baseline in Financial Difficulties Per EORTC QLQ-C30 Cycle 2 Day 15	-3.0 Units on a scale Interval -11.15 to 5.09
Change From Baseline in Financial Difficulties Per EORTC QLQ-C30 Cycle 3 Day 1	-0.7 Units on a scale Interval -8.39 to 6.94
Change From Baseline in Financial Difficulties Per EORTC QLQ-C30 Cycle 4 Day 1	1.6 Units on a scale Interval -6.81 to 9.91
Change From Baseline in Financial Difficulties Per EORTC QLQ-C30 Cycle 5 Day 1	5.1 Units on a scale Interval -5.25 to 15.51
Change From Baseline in Financial Difficulties Per EORTC QLQ-C30 Cycle 6 Day 1	3.2 Units on a scale Interval -8.31 to 14.76
Change From Baseline in Financial Difficulties Per EORTC QLQ-C30 End of treatment	10.5 Units on a scale Interval -0.2 to 21.15
Change From Baseline in Financial Difficulties Per EORTC QLQ-C30 Post-surgical follow-up	16.7 Units on a scale Interval 4.55 to 28.79

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of body image, participants self-rated how much they felt physically less attractive or less feminine, difficult to look at themselves naked, or dissatisfied with their body during the past week. Negative change from baseline indicates worsening of self-rated body image and positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=49 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23) Cycle 2 Day 15	-0.2 Units on a scale Interval -3.84 to 3.45
Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23) Cycle 1 Day 15	0.2 Units on a scale Interval -2.79 to 3.18
Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23) Cycle 2 Day 1	1.7 Units on a scale Interval -1.37 to 4.78
Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23) Cycle 3 Day 1	-0.4 Units on a scale Interval -3.53 to 2.79
Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23) Cycle 4 Day 1	-6.3 Units on a scale Interval -11.11 to -1.59
Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23) Cycle 5 Day 1	-9.4 Units on a scale Interval -15.17 to -3.69
Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23) Cycle 6 Day 1	-6.1 Units on a scale Interval -11.08 to -1.14
Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23) End of treatment	-6.9 Units on a scale Interval -12.1 to -1.63
Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23) Post-surgical follow-up	-13.8 Units on a scale Interval -20.64 to -6.95

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the sexual functioning scale, participants self-rated to what extent they were interested in sex and were sexually active (with or without intercourse) during the past 4 weeks. Negative change from baseline values indicates worsening of sexual functioning and positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=49 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23 Cycle 1 Day 15	-1.6 Units on a scale Interval -7.45 to 4.35
Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23 Cycle 2 Day 1	-3.0 Units on a scale Interval -9.33 to 3.27
Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23 Cycle 2 Day 15	-2.7 Units on a scale Interval -8.73 to 3.31
Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23 Cycle 3 Day 1	-0.4 Units on a scale Interval -7.33 to 6.59
Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23 Cycle 4 Day 1	-1.2 Units on a scale Interval -8.39 to 6.01
Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23 Cycle 5 Day 1	-3.5 Units on a scale Interval -11.17 to 4.15
Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23 Cycle 6 Day 1	-2.8 Units on a scale Interval -11.59 to 6.04
Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23 End of treatment	-3.4 Units on a scale Interval -11.11 to 4.25
Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23 Post-surgical follow-up	-10.9 Units on a scale Interval -20.55 to -1.29

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of sexual enjoyment, participants self-rated to what extent sex was enjoyable for them during the past 4 weeks. Negative change from baseline values indicates worsening of sexual enjoyment and positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=26 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23 Cycle 1 Day 15	-3.3 Units on a scale Interval -11.95 to 5.29
Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23 Cycle 2 Day 1	0.0 Units on a scale Interval -11.75 to 11.75
Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23 Cycle 2 Day 15	-3.7 Units on a scale Interval -16.28 to 8.87
Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23 Cycle 3 Day 1	-10.5 Units on a scale Interval -21.31 to 0.25
Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23 Cycle 4 Day 1	-12.3 Units on a scale Interval -23.27 to -1.29
Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23 Cycle 5 Day 1	-5.9 Units on a scale Interval -18.35 to 6.59
Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23 Cycle 6 Day 1	-12.8 Units on a scale Interval -28.29 to 2.65
Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23 End of treatment	-13.3 Units on a scale Interval -30.14 to 3.47
Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23 Post-surgical follow-up	-18.5 Units on a scale Interval -37.13 to 0.1

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of future perspective, participants self-rated how much they were worried about their health in the future. Negative change from baseline values indicates worsening of future perspective and positive change indicates improvement.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=49 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Future Perspective Per EORTC QLQ-BR23 Cycle 1 Day 15	3.1 Units on a scale Interval -3.91 to 10.11
Change From Baseline in Future Perspective Per EORTC QLQ-BR23 Cycle 2 Day 1	11.4 Units on a scale Interval 3.5 to 19.23
Change From Baseline in Future Perspective Per EORTC QLQ-BR23 Cycle 2 Day 15	11.6 Units on a scale Interval 3.91 to 19.34
Change From Baseline in Future Perspective Per EORTC QLQ-BR23 Cycle 3 Day 1	5.9 Units on a scale Interval -2.42 to 14.27
Change From Baseline in Future Perspective Per EORTC QLQ-BR23 Cycle 4 Day 1	5.6 Units on a scale Interval -2.36 to 13.48
Change From Baseline in Future Perspective Per EORTC QLQ-BR23 Cycle 5 Day 1	6.1 Units on a scale Interval -1.86 to 14.14
Change From Baseline in Future Perspective Per EORTC QLQ-BR23 Cycle 6 Day 1	6.7 Units on a scale Interval -3.87 to 17.21
Change From Baseline in Future Perspective Per EORTC QLQ-BR23 End of treatment	-2.0 Units on a scale Interval -12.26 to 8.34
Change From Baseline in Future Perspective Per EORTC QLQ-BR23 Post-surgical follow-up	10.3 Units on a scale Interval -0.95 to 21.64

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the systemic therapy side effects scale, participants self-rated the intensity of symptoms of dry mouth, unusual taste, pain and irritation of eyes, hair loss, feeling ill or unwell, hot flushes and headaches during the past week. Negative change from baseline= improvement of these side effects, positive change = deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=49 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23 Cycle 1 Day 15	7.1 Units on a scale Interval 3.74 to 10.43
Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23 Cycle 2 Day 1	6.6 Units on a scale Interval 3.7 to 9.5
Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23 Cycle 2 Day 15	9.1 Units on a scale Interval 5.9 to 12.26
Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23 Cycle 3 Day 1	11.2 Units on a scale Interval 7.57 to 14.87
Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23 Cycle 4 Day 1	15.0 Units on a scale Interval 10.93 to 19.0
Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23 Cycle 5 Day 1	13.5 Units on a scale Interval 9.1 to 17.97
Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23 Cycle 6 Day 1	16.5 Units on a scale Interval 11.57 to 21.44
Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23 End of treatment	6.9 Units on a scale Interval 3.22 to 10.5
Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23 Post-surgical follow-up	3.3 Units on a scale Interval -0.28 to 6.84

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the breast symptoms scale, participants self-rated how much they had pain or skin problems (e.g. itchy, dry, flaky) on or in the area of affected breast, and how much this area was swollen or oversensitive during the past week. Negative change from baseline indicates improvement of breast symptoms and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=49 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23 Cycle 1 Day 15	-2.1 Units on a scale Interval -5.97 to 1.71
Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23 Cycle 2 Day 1	-4.9 Units on a scale Interval -9.02 to -0.82
Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23 Cycle 2 Day 15	-9.1 Units on a scale Interval -13.61 to -4.6
Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23 Cycle 3 Day 1	-8.0 Units on a scale Interval -12.2 to -3.73
Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23 Cycle 4 Day 1	-5.6 Units on a scale Interval -9.72 to -1.39
Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23 Cycle 5 Day 1	-7.7 Units on a scale Interval -12.75 to -2.61
Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23 Cycle 6 Day 1	-6.4 Units on a scale Interval -11.85 to -0.93
Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23 End of treatment	0.2 Units on a scale Interval -5.55 to 6.04
Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23 Post-surgical follow-up	8.6 Units on a scale Interval -0.16 to 17.4

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the arm symptoms scale, participants self-rated how much they had pain in the arm or shoulder, how much the arm or hand was swollen, and difficulty in raising the arm or moving it sideways. Negative change from baseline indicates improvement of arm symptoms and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=49 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23 Cycle 1 Day 15	-1.6 Units on a scale Interval -4.59 to 1.49
Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23 Cycle 2 Day 1	-0.8 Units on a scale Interval -4.05 to 2.53
Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23 Cycle 2 Day 15	-1.6 Units on a scale Interval -5.25 to 2.15
Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23 Cycle 3 Day 1	-0.7 Units on a scale Interval -4.4 to 2.92
Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23 Cycle 4 Day 1	-1.3 Units on a scale Interval -4.4 to 1.76
Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23 Cycle 5 Day 1	0.3 Units on a scale Interval -3.73 to 4.32
Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23 Cycle 6 Day 1	-1.5 Units on a scale Interval -6.2 to 3.23
Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23 End of treatment	-1.0 Units on a scale Interval -5.18 to 3.22
Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23 Post-surgical follow-up	13.0 Units on a scale Interval 5.7 to 20.35

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the upset by hair loss scale, participants self-rated how upset they were due to loss of hair during the past week. Negative change from baseline values indicates improvement of upset by hair loss and positive change indicates deterioration.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=3 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23 Cycle 1 Day 15	0.0 Units on a scale 95% CI was not reported for n=1
Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23 Cycle 2 Day 1	-33.3 Units on a scale Interval -456.87 to 390.21
Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23 Cycle 2 Day 15	-11.1 Units on a scale Interval -137.6 to 115.37
Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23 Cycle 3 Day 1	33.33 Units on a scale Interval 33.33 to 33.33
Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23 Cycle 4 Day 1	11.1 Units on a scale Interval -161.26 to 183.48
Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23 End of treatment	33.33 Units on a scale 95% CI was not reported for n=1
Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23 Post-surgical follow-up	33.3 Units on a scale 95% CI was not reported for n=1

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: The analysis population included all participants who completed a baseline and at least one post-baseline QoL assessment prior to end of study treatment. Number of Participants Analyzed refers to participants who were evaluable for this outcome measure. Number analyzed refers to participants who were evaluable for this outcome measure at the specific visit.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Deterioration in nausea and vomiting symptoms was defined as a 10 point or more increase from baseline for that specific time point.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With Deterioration in Nausea/Vomiting Symptoms Cycle 1 Day 15	21 Participants
Number of Participants With Deterioration in Nausea/Vomiting Symptoms Cycle 2 Day 1	20 Participants
Number of Participants With Deterioration in Nausea/Vomiting Symptoms Cycle 2 Day 15	18 Participants
Number of Participants With Deterioration in Nausea/Vomiting Symptoms Cycle 3 Day 1	14 Participants
Number of Participants With Deterioration in Nausea/Vomiting Symptoms Cycle 4 Day 1	10 Participants
Number of Participants With Deterioration in Nausea/Vomiting Symptoms Cycle 5 Day 1	11 Participants
Number of Participants With Deterioration in Nausea/Vomiting Symptoms Cycle 6 Day 1	10 Participants
Number of Participants With Deterioration in Nausea/Vomiting Symptoms End of treatment	3 Participants
Number of Participants With Deterioration in Nausea/Vomiting Symptoms Post-surgical follow-up	5 Participants

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: The analysis population included all participants who completed a baseline and at least one post-baseline QoL assessment prior to end of study treatment. Number of Participants Analyzed refers to participants who were evaluable for this outcome measure. Number analyzed refers to participants who were evaluable for this outcome measure at the specific visit.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Improvement in nausea and vomiting symptoms was defined as a 10 point or more decrease from baseline for that specific time point.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With Improvement in Nausea/Vomiting Symptoms Cycle 1 Day 15	1 Participants
Number of Participants With Improvement in Nausea/Vomiting Symptoms Cycle 2 Day 1	2 Participants
Number of Participants With Improvement in Nausea/Vomiting Symptoms Cycle 2 Day 15	2 Participants
Number of Participants With Improvement in Nausea/Vomiting Symptoms Cycle 3 Day 1	2 Participants
Number of Participants With Improvement in Nausea/Vomiting Symptoms Cycle 4 Day 1	2 Participants
Number of Participants With Improvement in Nausea/Vomiting Symptoms Cycle 5 Day 1	2 Participants
Number of Participants With Improvement in Nausea/Vomiting Symptoms Cycle 6 Day 1	0 Participants
Number of Participants With Improvement in Nausea/Vomiting Symptoms End of treatment	3 Participants
Number of Participants With Improvement in Nausea/Vomiting Symptoms Post-surgical follow-up	3 Participants

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: The analysis population included all participants who completed a baseline and at least one post-baseline QoL assessment prior to end of study treatment. Number of Participants Analyzed refers to participants who were evaluable for this outcome measure. Number analyzed refers to participants who were evaluable for this outcome measure at the specific visit.

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. No change in nausea/vomiting symptoms=having neither deterioration (≥10 point increase from baseline) nor improvement (≥10 point decrease from baseline) for the time point.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=51 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With No Change in Nausea/Vomiting Symptoms Cycle 1 Day 15	21 Participants
Number of Participants With No Change in Nausea/Vomiting Symptoms Cycle 2 Day 1	24 Participants
Number of Participants With No Change in Nausea/Vomiting Symptoms Cycle 2 Day 15	24 Participants
Number of Participants With No Change in Nausea/Vomiting Symptoms Cycle 3 Day 1	30 Participants
Number of Participants With No Change in Nausea/Vomiting Symptoms Cycle 4 Day 1	31 Participants
Number of Participants With No Change in Nausea/Vomiting Symptoms Cycle 5 Day 1	26 Participants
Number of Participants With No Change in Nausea/Vomiting Symptoms Cycle 6 Day 1	21 Participants
Number of Participants With No Change in Nausea/Vomiting Symptoms End of treatment	29 Participants
Number of Participants With No Change in Nausea/Vomiting Symptoms Post-surgical follow-up	22 Participants

SECONDARY outcome

Timeframe: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Population: The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment. Post-menopausal participants were excluded from this evaluation. Number of participants analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.

Missed expected menstrual period was assessed electronically using the PRO CTCAE questionnaire, a PRO measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials. This objective captures the concept of fertility preservation through PRO, since there is a possible fertility sparing effect of talazoparib versus chemotherapy.

Outcome measures

Outcome measures
Measure	Talazoparib 1 mg QD n=32 Participants During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Baseline	0 Participants
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Cycle 1 Day 15	1 Participants
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Cycle 2 Day 1	0 Participants
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Cycle 2 Day 15	2 Participants
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Cycle 3 Day 1	0 Participants
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Cycle 4 Day 1	3 Participants
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Cycle 5 Day 1	1 Participants
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Cycle 6 Day 1	1 Participants
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) End of treatment	0 Participants
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Post-surgical follow-up	1 Participants

Adverse Events

Talazoparib 1 mg QD

Serious events: 11 serious events

Other events: 60 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Talazoparib 1 mg QD n=61 participants at risk During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Blood and lymphatic system disorders Anaemia	14.8% 9/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Neutropenia	1.6% 1/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Intestinal obstruction	1.6% 1/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Influenza like illness	1.6% 1/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Other adverse events

Other adverse events
Measure	Talazoparib 1 mg QD n=61 participants at risk During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose. Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first). Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).
Blood and lymphatic system disorders Anaemia	49.2% 30/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain	6.6% 4/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Constipation	31.1% 19/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Diarrhoea	21.3% 13/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Dry mouth	6.6% 4/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.6% 4/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Nausea	68.9% 42/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Stomatitis	9.8% 6/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Vomiting	11.5% 7/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Fatigue	78.7% 48/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Upper respiratory tract infection	19.7% 12/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Urinary tract infection	6.6% 4/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Alanine aminotransferase increased	11.5% 7/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Neutrophil count decreased	14.8% 9/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations White blood cell count decreased	14.8% 9/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Decreased appetite	13.1% 8/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Arthralgia	18.0% 11/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Back pain	8.2% 5/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Myalgia	14.8% 9/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	9.8% 6/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Dizziness	32.8% 20/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Dysgeusia	8.2% 5/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Headache	42.6% 26/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Anxiety	18.0% 11/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Insomnia	18.0% 11/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Reproductive system and breast disorders Breast pain	11.5% 7/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Reproductive system and breast disorders Menstruation irregular	6.6% 4/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Cough	14.8% 9/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.4% 10/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.8% 6/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	11.5% 7/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Alopecia	57.4% 35/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Pruritus	8.2% 5/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Rash	11.5% 7/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Hot flush	11.5% 7/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Hypertension	9.8% 6/61 • Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months). The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER