Trial Outcomes & Findings for Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors (NCT NCT02401347)

Last Updated: 2023-02-21

Results Overview

Objective response (OR) is a common measure of benefit. OR is defined as the number of participants who achieved complete response (CR) or partial clinical (PR), per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (v1.1). RECIST Criteria are assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays, as follows: * CR = Disappearance of all target and non-target lesions * PR = ≥30% decrease in the sum of the long diameter of target lesions * OR = CR+PR * Stable disease (SD) = Small changes that do not meet any of the above criteria * Progressive disease (PD) = ≥20% increase in long diameter of target lesions, and/or the appearance of any new lesion(s) The outcome is expressed as the number of participants that achieved either CR or PR within 24 weeks of the start of treatment, a number without dispersion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

up to 24 weeks

Results posted on

2023-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A - Triple-negative Breast Cancer Participants with advanced triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD) based on the Myriad HRD Assay. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.	Cohort B - HER2-negative Solid Tumor Participants with advanced HER2-negative solid tumor with a deleterious hereditary or cancer somatic mutation in one of the following genes: PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, RAD51C, RAD51D, MRE11, ATR, Fanconi anemia complementation group of genes. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.
Overall Study STARTED	1	20
Overall Study COMPLETED	1	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A - Triple-negative Breast Cancer n=1 Participants Participants with advanced triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD) based on the Myriad HRD Assay. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.	Cohort B - HER2-negative Solid Tumor n=20 Participants Participants with advanced HER2-negative solid tumor with a deleterious hereditary or cancer somatic mutation in one of the following genes: PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, RAD51C, RAD51D, MRE11, ATR, Fanconi anemia complementation group of genes. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	42.5 years STANDARD_DEVIATION NA • n=5 Participants	53.8 years STANDARD_DEVIATION 9.6 • n=7 Participants	53.6 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	20 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 24 weeks

Outcome measures

Outcome measures
Measure	Cohort A - Triple-negative Breast Cancer n=1 Participants Participants with advanced triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD) based on the Myriad HRD Assay. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.	Cohort B - HER2-negative Solid Tumor n=20 Participants Participants with advanced HER2-negative solid tumor with a deleterious hereditary or cancer somatic mutation in one of the following genes: PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, RAD51C, RAD51D, MRE11, ATR, Fanconi anemia complementation group of genes. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.
Objective Response (OR) Complete response (cR)	0 Participants	0 Participants
Objective Response (OR) Partial response (PR)	0 Participants	3 Participants
Objective Response (OR) Overall response (CR+PR)	0 Participants	3 Participants
Objective Response (OR) Stable disease (SD)	0 Participants	7 Participants
Objective Response (OR) Progressive disease (PD)	1 Participants	10 Participants

SECONDARY outcome

Timeframe: up to 24 weeks

Clinical benefit (CB) is a common measure of benefit. CB is defined as the number of participants who achieved complete response (CR); partial clinical (PR); or stable disease (SD), per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (v1.1). RECIST Criteria are assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays, as follows: * CR = Disappearance of all target and non-target lesions * PR = ≥30% decrease in the sum of the long diameter of target lesions * SD = Small changes that do not meet any of the above criteria * CB = CR+PR+SD * Progressive disease (PD) = ≥20% increase in long diameter of target lesions, and/or the appearance of any new lesion(s) The outcome is expressed as the number of participants that achieved either CR, PR, or SD within 24 weeks of the start of treatment, a number without dispersion.

Outcome measures

Outcome measures
Measure	Cohort A - Triple-negative Breast Cancer n=1 Participants Participants with advanced triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD) based on the Myriad HRD Assay. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.	Cohort B - HER2-negative Solid Tumor n=20 Participants Participants with advanced HER2-negative solid tumor with a deleterious hereditary or cancer somatic mutation in one of the following genes: PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, RAD51C, RAD51D, MRE11, ATR, Fanconi anemia complementation group of genes. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.
Clinical Benefit (CB) Complete response (CR)	0 Participants	0 Participants
Clinical Benefit (CB) Partial response (PR)	0 Participants	3 Participants
Clinical Benefit (CB) Stable disease (SD)	0 Participants	7 Participants
Clinical Benefit (CB) Clinical benefit (CB)	0 Participants	10 Participants
Clinical Benefit (CB) Progressive disease (PD)	1 Participants	10 Participants

SECONDARY outcome

Timeframe: 1 year

Progression-free survival (PFS) is a common measure of benefit. PFS means to remain alive with disease or tumor progression. Progression was defined per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (v1.1) as any ≥20% increase in long diameter of the target lesions, and/or the appearance of any new lesion(s). PFS is expressed as the number of participants who remained alive without progression after 1 year, a number without dispersion.

Outcome measures

Outcome measures
Measure	Cohort A - Triple-negative Breast Cancer n=1 Participants Participants with advanced triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD) based on the Myriad HRD Assay. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.	Cohort B - HER2-negative Solid Tumor n=20 Participants Participants with advanced HER2-negative solid tumor with a deleterious hereditary or cancer somatic mutation in one of the following genes: PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, RAD51C, RAD51D, MRE11, ATR, Fanconi anemia complementation group of genes. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.
Progression-free Survival (PFS)	0 Participants	1 Participants

Adverse Events

Cohort A - Triple-negative Breast Cancer

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Cohort B - HER2-negative Solid Tumor

Serious events: 3 serious events

Other events: 20 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A - Triple-negative Breast Cancer n=1 participants at risk Participants with advanced triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD) based on the Myriad HRD Assay. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.	Cohort B - HER2-negative Solid Tumor n=20 participants at risk Participants with advanced HER2-negative solid tumor with a deleterious hereditary or cancer somatic mutation in one of the following genes: PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, RAD51C, RAD51D, MRE11, ATR, Fanconi anemia complementation group of genes. Participants receive talazoparib 1 mg by mouth daily. Talazoparib Tosylate: Participants receive Talazoparib tosylate at 1 mg by mouth daily.
Investigations Thrombocytopenia	0.00% 0/1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.	5.0% 1/20 • Number of events 1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.	5.0% 1/20 • Number of events 1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.
Musculoskeletal and connective tissue disorders Weakness in extremity, right leg, progressing	0.00% 0/1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.	5.0% 1/20 • Number of events 1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.	5.0% 1/20 • Number of events 1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.
Musculoskeletal and connective tissue disorders Weakness in extremities, right side	0.00% 0/1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.	5.0% 1/20 • Number of events 1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.
Nervous system disorders Intracranial masses, supratentorial and infratentoria	0.00% 0/1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.	5.0% 1/20 • Number of events 1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.
Respiratory, thoracic and mediastinal disorders Pneumothorax, post-lung biopsy	0.00% 0/1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.	5.0% 1/20 • Number of events 1 • Participants were monitored for adverse through 30 days after the last dose of study medication, which had an average duration of 3 cycles (28 days per cycle) and were followed for survival through 1 year.

Other adverse events

Additional Information

Melinda L Telli, MD

Stanford Medicine at Stanford University

Phone: (650) 724-9533

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place