Trial Outcomes & Findings for Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer (NCT NCT04849364)

Last Updated: 2025-05-31

Results Overview

DFS is defined as the duration of time from arm assignment to time of a DFS event, defined as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

2 years

Results posted on

2025-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive -Standard of Care Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.
Overall Study STARTED	1	5	46
Overall Study COMPLETED	1	4	46
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive -Standard of Care Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.
Overall Study Eligibility criteria not meet	0	1	0

Baseline Characteristics

Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway n=1 Participants Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive - Standard of Care n=4 Participants Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice n=46 Participants Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Total n=51 Participants Total of all reporting groups
Age, Continuous	47 years n=5 Participants	55 years n=7 Participants	51 years n=5 Participants	51 years n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	46 Participants n=5 Participants	51 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	41 Participants n=5 Participants	46 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	33 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	4 participants n=7 Participants	46 participants n=5 Participants	51 participants n=4 Participants
ECOG Performance Status ECOG = 0	1 Participants n=5 Participants	2 Participants n=7 Participants	37 Participants n=5 Participants	40 Participants n=4 Participants
ECOG Performance Status ECOG = 1	0 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants
ECOG Performance Status Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway n=1 Participants Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive - Standard of Care Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.
ARM 1c: Disease Free Survival (DFS) at 2 Years	100 Percentage of participants Interval 100.0 to 100.0	—	—

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway n=4 Participants Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive - Standard of Care Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.
ARM 2: Disease Free Survival (DFS) at 2 Years	0 Percentage of participants Not enough events occur to calculate 95% confidence interval.	—	—

SECONDARY outcome

Timeframe: 2 years

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Disease free survival was defined as all patients who received at least one dose of study treatment and have had at least one post baseline disease assessment or die before first assessment.

Outcome measures

Outcome measures
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway n=40 Participants Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive - Standard of Care Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.
ARM 3:Disease Free Survival (DFS) at 2 Years	40.2 Percentage of participants Interval 11.7 to 67.9	—	—

SECONDARY outcome

Timeframe: Up to 29 months

Comparison of overall DFS in Arms 1c, 2, 3. DFS is defined as the duration of time from arm assignment to time of a DFS event such as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause

Outcome measures

Outcome measures
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway n=1 Participants Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive - Standard of Care n=4 Participants Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice n=40 Participants Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.
Overall Disease Free Survival (DFS)	27.7 Months Not enough events occur to calculate 95% confidence interval	8.1 Months Interval 2.9 to Not enough events occur to calculate upper 95% confidence interval	23.1 Months Interval 16.7 to Not enough events occur to calculate upper 95% confidence interval

SECONDARY outcome

Timeframe: Up to 29 months

DDFS is defined as the duration of time from arm assignment to time of recurrence of breast cancer outside the breast and/or death from any cause.

Outcome measures

Outcome measures
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway n=1 Participants Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive - Standard of Care n=4 Participants Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice n=40 Participants Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.
Overall Distant Disease Free Survival (DDFS)	27.7 Months Not enough events occur to calculate 95% confidence interval	8.1 Months Interval 3.1 to Not enough events occur to calculate upper 95% confidence interval	23.1 Months Interval 18.8 to Not enough events occur to calculate upper 95% confidence interval

SECONDARY outcome

Timeframe: 1 year

Compare 1-year DFS in Arms 1c, 2, 3. DFS is defined as the duration of time from arm assignment to time of a DFS event, defined as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause

Outcome measures

Outcome measures
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway n=1 Participants Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive - Standard of Care n=4 Participants Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice n=40 Participants Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.
1-year Disease Free Survival (DFS)	100 Percentage of participants Interval 100.0 to 100.0	0 Percentage of participants Not enough events occur to calculate 95% confidence interval.	79.8 Percentage of participants Interval 59.9 to 90.6

SECONDARY outcome

Timeframe: 5 years

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint 5 -years Overall survival was defined as all patients who received at least one dose of study treatment and have follow-up up to 5 years. Because of the early termination, 5-year overall survival was not reached by any subjects.

Overall survival is defined as the time from date of treatment start until death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 16 months

Adverse events (regardless of relationship with study drug) will be assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) criteria v5

Outcome measures

Outcome measures
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway n=1 Participants Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive - Standard of Care n=4 Participants Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice n=46 Participants Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.
Number of Participants With Adverse Events	1 Participants	3 Participants	42 Participants

Adverse Events

Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm 2: ctDNA Positive - Standard of Care

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Arm 3: ctDNA Negative - Physician's Choice

Serious events: 3 serious events

Other events: 33 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway n=1 participants at risk Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---\> +/- standard of care pembrolizumab	Arm 2: ctDNA Positive - Standard of Care n=4 participants at risk Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.	Arm 3: ctDNA Negative - Physician's Choice n=46 participants at risk Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician. Capecitabine: Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles Pembrolizumab: Per standard of care.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	0.00% 0/46 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.00% 0/1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	0.00% 0/46 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.
Vascular disorders HYPOTENSION	0.00% 0/1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	0.00% 0/46 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.
Gastrointestinal disorders COLITIS	0.00% 0/1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	0.00% 0/4 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	2.2% 1/46 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.
Gastrointestinal disorders DIARRHEA	0.00% 0/1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	0.00% 0/4 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	2.2% 1/46 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	0.00% 0/1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	0.00% 0/4 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.	2.2% 1/46 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 35 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from time of initiation of study drug until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, up to a maximum of 16 months.

Other adverse events

Additional Information

Fauzia Sharmin

Hoosier Cancer Research Network

Phone: 317-921-2050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place