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A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) (EMBRACA)

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ClinicalTrials.gov Identifier: NCT01945775
Recruitment Status : Completed
First Posted : September 19, 2013
Results First Posted : October 3, 2018
Last Update Posted : January 20, 2022
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Neoplasms
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Interventions Drug: talazoparib
Drug: Physician's-Choice
Enrollment 431
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description Participants received talazoparib 1 milligram (mg), orally, once daily until radiographic disease progression as determined by the central independent radiology facility (IRF), unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days. Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 milligram per meter square (mg/m^2) orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute intravenous (IV) infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Period Title: Overall Study
Started 287 144
Treated 286 126
Completed 0 0
Not Completed 287 144
Reason Not Completed
Death             214             98
Lost to Follow-up             12             7
Withdrawal by Subject             11             21
Other             50             18
Arm/Group Title Talazoparib Physician's Choice Treatment Total
Hide Arm/Group Description Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days. Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days. Total of all reporting groups
Overall Number of Baseline Participants 287 144 431
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) analysis population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 287 participants 144 participants 431 participants
47.5  (11.61) 49.4  (12.12) 48.1  (11.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 144 participants 431 participants
Female
283
  98.6%
141
  97.9%
424
  98.4%
Male
4
   1.4%
3
   2.1%
7
   1.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 144 participants 431 participants
Hispanic or Latino
31
  10.8%
15
  10.4%
46
  10.7%
Not Hispanic or Latino
207
  72.1%
111
  77.1%
318
  73.8%
Unknown or Not Reported
49
  17.1%
18
  12.5%
67
  15.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 144 participants 431 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
31
  10.8%
16
  11.1%
47
  10.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
   3.8%
1
   0.7%
12
   2.8%
White
190
  66.2%
108
  75.0%
298
  69.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
55
  19.2%
19
  13.2%
74
  17.2%
1.Primary Outcome
Title Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment
Hide Description IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.
Time Frame Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis population included all randomized participants.
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 287 144
Median (95% Confidence Interval)
Unit of Measure: months
8.6
(7.2 to 9.3)
5.6
(4.2 to 6.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib, Physician's Choice Treatment
Comments Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio, log
Estimated Value 0.542
Confidence Interval (2-Sided) 95%
0.413 to 0.711
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Objective Response: Investigator Assessment
Hide Description Investigator assessed objective response was defined as the percentage of participants with a partial response (PR) or complete response (CR) as defined by RECIST v1.1. For target lesions: 1) CR: disappearance of all non-nodal target lesions. Target lymph nodes must reduce to less than 10 mm in short axis. 2) PR: At least a 30% decrease in the sum of diameters of target lesions, compared to the sum at baseline. For non-target lesions, CR: disappearance of all non-target lesions. Percentage of participants with objective response reported are based upon unconfirmed CR/PR.
Time Frame Baseline until radiologic progressive disease or death due to any cause (up to a maximum duration of 36.9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with measurable disease analysis population included all participants in the ITT population who had at least 1 target lesion identified at baseline.
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 219 114
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62.6
(55.78 to 68.99)
27.2
(19.28 to 36.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib, Physician's Choice Treatment
Comments p-value was based on stratified Cochran-Mantel-Haenszel method. Stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.99
Confidence Interval (2-Sided) 95%
2.93 to 8.83
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time (in months) from randomization to death due to any cause. If death was not observed at the time of study cut-off date or permanently lost to follow-up, OS was censored at the date the participant was last known to be alive on or before the study cut-off date, whichever was earlier. The analysis was performed by Kaplan-Meier method.
Time Frame Baseline until death due to any cause or analysis cut-off, up to a maximum duration of 61.4 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all randomized participants.
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 287 144
Median (95% Confidence Interval)
Unit of Measure: months
19.3
(16.6 to 22.5)
19.5
(17.4 to 22.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib, Physician's Choice Treatment
Comments Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1693
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.848
Confidence Interval (2-Sided) 95%
0.670 to 1.073
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Trough Plasma Talazoparib Concentrations
Hide Description A predose PK sample was considered dose-compliant based on the following criteria: A participant must have received 21 consecutive days of 1 mg talazoparib without dosing interruption prior to sample collection; and the predose PK sample must have been collected 24 hours +/- 10 percent (2 hours and 24 minutes) after the previous day's dose and no more than 5 minutes (0.083 hours) after the administration of the dose on the day of PK sample collection.
Time Frame Predose on Day 1 of Cycle 2, 3 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included participants who received at least 1 dose of talazoparib and had dose compliant pharmacokinetic (PK) predose sample. Here, "number analyzed" signifies number of participants who were evaluable for the specified categories. This endpoint was not planned to be analyzed for the reporting arm "Physician's Choice Treatment".
Arm/Group Title Talazoparib
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 175
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Picogram per milliliter (pg/mL)
Cycle 2 Day 1: Predose Number Analyzed 137 participants
3370
(76.9%)
Cycle 3 Day 1: Predose Number Analyzed 120 participants
3570
(49.9%)
Cycle 4 Day 1: Predose Number Analyzed 107 participants
3400
(48.4%)
5.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description An adverse events (AE) was any untoward medical occurrence (e.g., sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug or the day before initiation of a new antineoplastic therapy or 30 days after the date of the last dose date of study drug, whichever occurred first, that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Time Frame Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 286 126
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
282
  98.6%
123
  97.6%
SAEs
103
  36.0%
39
  31.0%
6.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Hematology
Hide Description Toxicity grades were evaluated based on as National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key hematology parameters included hemoglobin (gram per liter [g/L]), leukocytes (10^6 cells per liter), lymphocytes (10^6 cells per liter), neutrophils (10^6 cells per liter), and platelets (10^9 cells per liter). Low value indicated lower values than the baseline values and high value indicated higher values than the baseline values. Only those categories in which at least 1 participant had data were reported.
Time Frame Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 286 126
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin: Low value
115
  40.2%
8
   6.3%
Leukocytes: Low value
43
  15.0%
31
  24.6%
Lymphocytes: Low value
54
  18.9%
11
   8.7%
Neutrophils: Low value
65
  22.7%
48
  38.1%
Platelets: Low value
44
  15.4%
2
   1.6%
7.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Chemistry
Hide Description Toxicity grades were evaluated based on as NCI CTCAE v4.03. NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe) and grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key chemistry parameters included alanine aminotransferase (units per liter), alkaline phosphatase (units per liter), aspartate aminotransferase (units per liter) and bilirubin (micromole per liter). High value indicated higher values than the baseline values and low value indicated lower values than the baseline values. Only those categories in which at least 1 participant had data were reported.
Time Frame Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 286 126
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine Aminotransferase: High Value
5
   1.7%
3
   2.4%
Alkaline Phosphatase: High Value
6
   2.1%
2
   1.6%
Aspartate Aminotransferase: High Value
7
   2.4%
4
   3.2%
Bilirubin: High Value
4
   1.4%
1
   0.8%
8.Secondary Outcome
Title Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs
Hide Description Criteria for potentially clinically significant changes in vital signs included a) Systolic blood pressure: 1) absolute results (AB) greater than (>) 180 millimeter of mercury (mmHg) and increase from baseline (IFB) greater than or equal to (>=) 40 mmHg, 2) absolute results less than (<) 90 mmHg and decrease from baseline (DFB) >30 mmHg; b) Diastolic blood pressure: 1) absolute results >110 mmHg and >=30 mmHg increase from baseline, 2) absolute results <50 mmHg and >20 mmHg decrease from baseline 3) >=20 mmHg increase from baseline; c) Heart rate: 1) absolute results>120 beats per minute [bpm] and >30 bpm increase from baseline, 2) absolute results <50 bpm and >20 bpm decrease from baseline and d) Weight: >10 percent [%] decrease from baseline.
Time Frame Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 286 126
Measure Type: Count of Participants
Unit of Measure: Participants
SBP: AB>180 mmHg and IFB >=40 mmHg
3
   1.0%
2
   1.6%
SBP: AB<90 mmHg and DFB >30 mmHg
8
   2.8%
2
   1.6%
DBP: AB>110 mmHg and IFB >=30 mmHg
0
   0.0%
0
   0.0%
DBP: AB<50 mmHg and DFB>20 mmHg
15
   5.2%
7
   5.6%
DBP: IFB>=20 mmHg
39
  13.6%
13
  10.3%
Heart rate: AB >120 bpm and IFB >30 bpm
6
   2.1%
2
   1.6%
Heart rate: AB <50 bpm and DFB >20 bpm
2
   0.7%
0
   0.0%
Weight: >10% DFB
23
   8.0%
13
  10.3%
9.Secondary Outcome
Title Number of Participants Taking At-least One Concomitant Medication
Hide Description Any medication (other than study drug) which was administered to participants during study after first dose of study drug were considered as concomitant medications.
Time Frame Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 286 126
Measure Type: Count of Participants
Unit of Measure: Participants
281
  98.3%
126
 100.0%
10.Other Pre-specified Outcome
Title Duration of Response (DOR): Investigator Assessment
Hide Description DOR = time from first radiographic documentation of OR (PR or CR) till radiographic disease progression (PD) as per RECIST v1.1 by investigator assessment or to death due to any cause, whichever was first. RECIST 1.1, a) target lesion (TL): CR= disappearance of all non-nodal TL, target lymph nodes reduce to <10 mm in short axis, PR= at least 30% decrease in sum of diameters of TL, compared to the sum at baseline, PD= at least 20% increase in sum of TL measurements, compared to smallest sum on study including baseline, absolute increase in sum has to be at least 5 mm; b) for non-TL: CR= disappearance of all non-TL, PD= unequivocal progression of non-TL, such that treatment has failed, disease is progressing, regardless of status of TL; c) PD =and/or appearance of >=1 new lesions. DOR = (earliest date of progression, death, or censoring-date of first documented OR + 1)/30.4375. Analysis was performed by Kaplan-Meier method.
Time Frame From first documentation of CR or PR until disease progression or death due to any cause, whichever occurred first (up to 36.9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT with measurable disease analysis population included all participants in the ITT population who had at least 1 target lesion identified at baseline.
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 219 114
Median (Inter-Quartile Range)
Unit of Measure: months
5.4
(2.8 to 11.2)
3.1
(2.4 to 6.7)
11.Other Pre-specified Outcome
Title Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at Average Duration Over Week 4 up to Week 160
Hide Description EORTC QLQ-C30: cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each question assessed on 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1= very poor to 7= excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning. Change from baseline was calculated by subtracting the baseline value from the average value of Week 4 to 160.
Time Frame Baseline, Week 4 up to Week 160
Hide Outcome Measure Data
Hide Analysis Population Description
Patient-reported outcomes (PRO) evaluable population included all participants who completed the PRO questionnaire at baseline and at least 1 visit post-baseline.
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 262 114
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.0
(1.2 to 4.8)
-5.4
(-8.8 to -2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib, Physician's Choice Treatment
Comments Analysis was based on repeated measures mixed-effect model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate. Analysis was based on restricted maximum likelihood using unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.4
Confidence Interval (2-Sided) 95%
4.6 to 12.3
Estimation Comments [Not Specified]
12.Other Pre-specified Outcome
Title Time to Deterioration (TTD) in Global Health Status/Quality of Life (QOL)
Hide Description TTD in global health status (GHS)/QoL=time (in months) from randomization to the first observation with >=10 point decrease and no subsequent observations with<10 point decrease from baseline in GHS/QoL score based on EORTC-QLQ-C30. EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to assess participant quality of life. Question 29 and 30 were used to evaluate GHS/QoL. Each question was assessed on a 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.
Time Frame Baseline up to a maximum duration of 36.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
PRO-evaluable population included all participants who completed the PRO questionnaire at baseline and at least 1 visit post-baseline.
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 262 114
Median (95% Confidence Interval)
Unit of Measure: months
24.3 [1] 
(13.8 to NA)
6.3
(4.9 to 12.2)
[1]
Upper limit of 95% CI was not estimable, since only few participants had event.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib, Physician's Choice Treatment
Comments Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.376
Confidence Interval (2-Sided) 95%
0.257 to 0.549
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Time to Deterioration (TTD) in Breast Symptoms Scale as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)
Hide Description TTD was defined as the time (in months) from randomization to the first observation with a>=10 point increase and no subsequent observations with a <10 point increase from baseline in breast symptom score based on the EORTC-QLQ-BR23. EORTC-QLQ-BR23 is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much), higher scores=high level of symptom/problems.
Time Frame Baseline up to a maximum duration of 36.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
PRO-evaluable population included all participants who completed the PRO questionnaire at baseline and at least 1 visit post-baseline.
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description:
Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
Overall Number of Participants Analyzed 262 114
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [2] 
(10.3 to NA)
[1]
Median and 95% CI was not estimable due to the low number of participants with event.
[2]
Median and upper limit of 95% CI was not estimable due to the low number of participants with event.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Talazoparib, Physician's Choice Treatment
Comments Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0053
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.392
Confidence Interval (2-Sided) 95%
0.198 to 0.775
Estimation Comments [Not Specified]
Time Frame Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Adverse Event Reporting Description Same event may appear as both an AE and a SAE. However, what is presented are distinct events. 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. AEs and SAEs were collected for safety population.
 
Arm/Group Title Talazoparib Physician's Choice Treatment
Hide Arm/Group Description Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days. Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
All-Cause Mortality
Talazoparib Physician's Choice Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   220/286 (76.92%)   100/126 (79.37%) 
Hide Serious Adverse Events
Talazoparib Physician's Choice Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   103/286 (36.01%)   39/126 (30.95%) 
Blood and lymphatic system disorders     
Anaemia * 1  18/286 (6.29%)  0/126 (0.00%) 
Neutropenia * 1  3/286 (1.05%)  4/126 (3.17%) 
Thrombocytopenia * 1  2/286 (0.70%)  0/126 (0.00%) 
Febrile neutropenia * 1  1/286 (0.35%)  1/126 (0.79%) 
Leukopenia * 1  1/286 (0.35%)  0/126 (0.00%) 
Pancytopenia * 1  2/286 (0.70%)  0/126 (0.00%) 
Cardiac disorders     
Pericardial effusion * 1  3/286 (1.05%)  0/126 (0.00%) 
Atrial flutter * 1  1/286 (0.35%)  0/126 (0.00%) 
Cardiac tamponade * 1  1/286 (0.35%)  0/126 (0.00%) 
Eye disorders     
Diplopia * 1  2/286 (0.70%)  0/126 (0.00%) 
Gastrointestinal disorders     
Vomiting * 1  5/286 (1.75%)  2/126 (1.59%) 
Abdominal pain * 1  3/286 (1.05%)  2/126 (1.59%) 
Nausea * 1  3/286 (1.05%)  1/126 (0.79%) 
Ascites * 1  1/286 (0.35%)  0/126 (0.00%) 
Constipation * 1  1/286 (0.35%)  0/126 (0.00%) 
Gastrointestinal inflammation * 1  1/286 (0.35%)  0/126 (0.00%) 
Pancreatitis * 1  1/286 (0.35%)  0/126 (0.00%) 
Diarrhoea * 1  0/286 (0.00%)  3/126 (2.38%) 
Abdominal pain upper * 1  0/286 (0.00%)  2/126 (1.59%) 
Colitis * 1  0/286 (0.00%)  1/126 (0.79%) 
Abdominal hernia * 1  1/286 (0.35%)  0/126 (0.00%) 
General disorders     
Pyrexia * 1  8/286 (2.80%)  2/126 (1.59%) 
General physical health deterioration * 1  2/286 (0.70%)  2/126 (1.59%) 
Non-cardiac chest pain * 1  2/286 (0.70%)  0/126 (0.00%) 
Malaise * 1  1/286 (0.35%)  0/126 (0.00%) 
Oedema peripheral * 1  1/286 (0.35%)  0/126 (0.00%) 
Discomfort * 1  0/286 (0.00%)  1/126 (0.79%) 
Localised oedema * 1  0/286 (0.00%)  1/126 (0.79%) 
Mucosal inflammation * 1  0/286 (0.00%)  1/126 (0.79%) 
Hepatobiliary disorders     
Liver disorder * 1  1/286 (0.35%)  0/126 (0.00%) 
Venoocclusive liver disease * 1  1/286 (0.35%)  0/126 (0.00%) 
Cholecystitis * 1  1/286 (0.35%)  0/126 (0.00%) 
Immune system disorders     
Contrast media allergy * 1  1/286 (0.35%)  0/126 (0.00%) 
Infections and infestations     
Pneumonia * 1  3/286 (1.05%)  2/126 (1.59%) 
Cytomegalovirus infection * 1  2/286 (0.70%)  0/126 (0.00%) 
Respiratory tract infection * 1  2/286 (0.70%)  0/126 (0.00%) 
Anal abscess * 1  1/286 (0.35%)  0/126 (0.00%) 
Breast cellulitis * 1  1/286 (0.35%)  0/126 (0.00%) 
Furuncle * 1  1/286 (0.35%)  0/126 (0.00%) 
Gastroenteritis viral * 1  1/286 (0.35%)  0/126 (0.00%) 
Influenza * 1  1/286 (0.35%)  0/126 (0.00%) 
Lower respiratory tract infection * 1  1/286 (0.35%)  0/126 (0.00%) 
Upper respiratory tract infection * 1  1/286 (0.35%)  0/126 (0.00%) 
Urinary tract infection * 1  1/286 (0.35%)  0/126 (0.00%) 
Viral upper respiratory tract infection * 1  1/286 (0.35%)  0/126 (0.00%) 
Cellulitis * 1  1/286 (0.35%)  1/126 (0.79%) 
Device related infection * 1  0/286 (0.00%)  1/126 (0.79%) 
Sepsis * 1  0/286 (0.00%)  1/126 (0.79%) 
Staphylococcal bacteraemia * 1  0/286 (0.00%)  1/126 (0.79%) 
Mycobacterium avium complex infection * 1  1/286 (0.35%)  0/126 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  1/286 (0.35%)  0/126 (0.00%) 
Ankle fracture * 1  2/286 (0.70%)  0/126 (0.00%) 
Fall * 1  1/286 (0.35%)  0/126 (0.00%) 
Fibula fracture * 1  1/286 (0.35%)  0/126 (0.00%) 
Foot fracture * 1  1/286 (0.35%)  0/126 (0.00%) 
Hip fracture * 1  1/286 (0.35%)  0/126 (0.00%) 
Scar * 1  1/286 (0.35%)  0/126 (0.00%) 
Spinal compression fracture * 1  1/286 (0.35%)  0/126 (0.00%) 
Tibia fracture * 1  1/286 (0.35%)  0/126 (0.00%) 
Spinal fracture * 1  1/286 (0.35%)  0/126 (0.00%) 
Investigations     
Platelet count decreased * 1  4/286 (1.40%)  0/126 (0.00%) 
Neutrophil count decreased * 1  1/286 (0.35%)  2/126 (1.59%) 
Hepatic enzyme increased * 1  1/286 (0.35%)  0/126 (0.00%) 
International normalised ratio increased * 1  0/286 (0.00%)  1/126 (0.79%) 
Alanine aminotransferase increased * 1  1/286 (0.35%)  0/126 (0.00%) 
Aspartate aminotransferase increased * 1  1/286 (0.35%)  0/126 (0.00%) 
Metabolism and nutrition disorders     
Hypercalcaemia * 1  2/286 (0.70%)  0/126 (0.00%) 
Dehydration * 1  0/286 (0.00%)  2/126 (1.59%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  5/286 (1.75%)  1/126 (0.79%) 
Bone pain * 1  2/286 (0.70%)  0/126 (0.00%) 
Pain in extremity * 1  2/286 (0.70%)  0/126 (0.00%) 
Muscular weakness * 1  1/286 (0.35%)  1/126 (0.79%) 
Pathological fracture * 1  1/286 (0.35%)  1/126 (0.79%) 
Arthralgia * 1  1/286 (0.35%)  0/126 (0.00%) 
Intervertebral disc protrusion * 1  1/286 (0.35%)  0/126 (0.00%) 
Musculoskeletal chest pain * 1  1/286 (0.35%)  0/126 (0.00%) 
Osteolysis * 1  1/286 (0.35%)  0/126 (0.00%) 
Osteonecrosis of jaw * 1  1/286 (0.35%)  0/126 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to central nervous system * 1  4/286 (1.40%)  0/126 (0.00%) 
Malignant pleural effusion * 1  1/286 (0.35%)  1/126 (0.79%) 
Basal cell carcinoma * 1  1/286 (0.35%)  0/126 (0.00%) 
Breast cancer * 1  1/286 (0.35%)  0/126 (0.00%) 
Glioblastoma multiforme * 1  1/286 (0.35%)  0/126 (0.00%) 
Metastases to liver * 1  1/286 (0.35%)  0/126 (0.00%) 
Metastases to lymph nodes * 1  1/286 (0.35%)  0/126 (0.00%) 
Metastases to meninges * 1  1/286 (0.35%)  0/126 (0.00%) 
Metastases to pancreas * 1  1/286 (0.35%)  0/126 (0.00%) 
Squamous cell carcinoma of skin * 1  1/286 (0.35%)  0/126 (0.00%) 
Acute promyelocytic leukaemia * 1  0/286 (0.00%)  1/126 (0.79%) 
Malignant melanoma * 1  0/286 (0.00%)  1/126 (0.79%) 
Pericarditis malignant * 1  0/286 (0.00%)  1/126 (0.79%) 
Second primary malignancy * 1  0/286 (0.00%)  1/126 (0.79%) 
Myelodysplastic syndrome * 1  1/286 (0.35%)  0/126 (0.00%) 
Nervous system disorders     
Headache * 1  5/286 (1.75%)  0/126 (0.00%) 
Seizure * 1  2/286 (0.70%)  0/126 (0.00%) 
Dizziness * 1  2/286 (0.70%)  1/126 (0.79%) 
Aphasia * 1  1/286 (0.35%)  0/126 (0.00%) 
Cerebral haemorrhage * 1  1/286 (0.35%)  0/126 (0.00%) 
Neurological symptom * 1  1/286 (0.35%)  0/126 (0.00%) 
Syncope * 1  1/286 (0.35%)  0/126 (0.00%) 
Transient ischaemic attack * 1  1/286 (0.35%)  0/126 (0.00%) 
Encephalopathy * 1  0/286 (0.00%)  1/126 (0.79%) 
Nervous system disorder * 1  0/286 (0.00%)  2/126 (1.59%) 
Hydrocephalus * 1  1/286 (0.35%)  0/126 (0.00%) 
Cerebrovascular accident * 1  0/286 (0.00%)  1/126 (0.79%) 
Psychiatric disorders     
Anxiety * 1  1/286 (0.35%)  0/126 (0.00%) 
Depressed mood * 1  1/286 (0.35%)  0/126 (0.00%) 
Renal and urinary disorders     
Renal colic * 1  1/286 (0.35%)  0/126 (0.00%) 
Urinary retention * 1  1/286 (0.35%)  0/126 (0.00%) 
Reproductive system and breast disorders     
Bartholin's cyst * 1  1/286 (0.35%)  0/126 (0.00%) 
Uterine haemorrhage * 1  0/286 (0.00%)  1/126 (0.79%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  4/286 (1.40%)  7/126 (5.56%) 
Dyspnoea * 1  4/286 (1.40%)  0/126 (0.00%) 
Pulmonary embolism * 1  6/286 (2.10%)  0/126 (0.00%) 
Cough * 1  1/286 (0.35%)  0/126 (0.00%) 
Lung disorder * 1  1/286 (0.35%)  0/126 (0.00%) 
Obstructive airways disorder * 1  1/286 (0.35%)  0/126 (0.00%) 
Pneumothorax * 1  1/286 (0.35%)  0/126 (0.00%) 
Bronchopneumopathy * 1  0/286 (0.00%)  1/126 (0.79%) 
Skin and subcutaneous tissue disorders     
Scar pain * 1  1/286 (0.35%)  0/126 (0.00%) 
Surgical and medical procedures     
Breast reconstruction * 1  1/286 (0.35%)  0/126 (0.00%) 
Salpingo-oophorectomy * 1  0/286 (0.00%)  1/126 (0.79%) 
Lymphadenectomy * 1  0/286 (0.00%)  1/126 (0.79%) 
Vascular disorders     
Deep vein thrombosis * 1  1/286 (0.35%)  2/126 (1.59%) 
Hypotension * 1  1/286 (0.35%)  0/126 (0.00%) 
1
Term from vocabulary, MedDRA v.20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Talazoparib Physician's Choice Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   282/286 (98.60%)   123/126 (97.62%) 
Blood and lymphatic system disorders     
Anaemia * 1  153/286 (53.50%)  24/126 (19.05%) 
Neutropenia * 1  77/286 (26.92%)  36/126 (28.57%) 
Thrombocytopenia * 1  50/286 (17.48%)  7/126 (5.56%) 
Leukopenia * 1  24/286 (8.39%)  12/126 (9.52%) 
Eye disorders     
Lacrimation increased * 1  10/286 (3.50%)  9/126 (7.14%) 
Gastrointestinal disorders     
Nausea * 1  142/286 (49.65%)  60/126 (47.62%) 
Diarrhoea * 1  68/286 (23.78%)  32/126 (25.40%) 
Vomiting * 1  74/286 (25.87%)  28/126 (22.22%) 
Constipation * 1  66/286 (23.08%)  28/126 (22.22%) 
Abdominal pain * 1  36/286 (12.59%)  18/126 (14.29%) 
Dyspepsia * 1  33/286 (11.54%)  10/126 (7.94%) 
Stomatitis * 1  24/286 (8.39%)  7/126 (5.56%) 
Dry mouth * 1  19/286 (6.64%)  8/126 (6.35%) 
Abdominal pain upper * 1  28/286 (9.79%)  5/126 (3.97%) 
General disorders     
Fatigue * 1  147/286 (51.40%)  54/126 (42.86%) 
Asthenia * 1  45/286 (15.73%)  12/126 (9.52%) 
Pyrexia * 1  31/286 (10.84%)  21/126 (16.67%) 
Oedema peripheral * 1  23/286 (8.04%)  8/126 (6.35%) 
Mucosal inflammation * 1  16/286 (5.59%)  9/126 (7.14%) 
Non-cardiac chest pain * 1  17/286 (5.94%)  5/126 (3.97%) 
Influenza like illness * 1  20/286 (6.99%)  2/126 (1.59%) 
Infections and infestations     
Upper respiratory tract infection * 1  41/286 (14.34%)  13/126 (10.32%) 
Viral upper respiratory tract infection * 1  35/286 (12.24%)  8/126 (6.35%) 
Urinary tract infection * 1  30/286 (10.49%)  3/126 (2.38%) 
Sinusitis * 1  21/286 (7.34%)  4/126 (3.17%) 
Investigations     
Neutrophil count decreased * 1  30/286 (10.49%)  18/126 (14.29%) 
Weight decreased * 1  23/286 (8.04%)  15/126 (11.90%) 
Platelet count decreased * 1  36/286 (12.59%)  4/126 (3.17%) 
White blood cell count decreased * 1  32/286 (11.19%)  5/126 (3.97%) 
Aspartate aminotransferase increased * 1  15/286 (5.24%)  15/126 (11.90%) 
Alanine aminotransferase increased * 1  11/286 (3.85%)  15/126 (11.90%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  62/286 (21.68%)  28/126 (22.22%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  67/286 (23.43%)  19/126 (15.08%) 
Arthralgia * 1  55/286 (19.23%)  15/126 (11.90%) 
Pain in extremity * 1  45/286 (15.73%)  14/126 (11.11%) 
Musculoskeletal chest pain * 1  28/286 (9.79%)  9/126 (7.14%) 
Myalgia * 1  25/286 (8.74%)  14/126 (11.11%) 
Musculoskeletal pain * 1  29/286 (10.14%)  9/126 (7.14%) 
Neck pain * 1  17/286 (5.94%)  6/126 (4.76%) 
Bone pain * 1  15/286 (5.24%)  7/126 (5.56%) 
Muscle spasms * 1  18/286 (6.29%)  3/126 (2.38%) 
Nervous system disorders     
Headache * 1  96/286 (33.57%)  29/126 (23.02%) 
Dizziness * 1  51/286 (17.83%)  13/126 (10.32%) 
Dysgeusia * 1  30/286 (10.49%)  11/126 (8.73%) 
Paraesthesia * 1  13/286 (4.55%)  15/126 (11.90%) 
Neuropathy peripheral * 1  19/286 (6.64%)  9/126 (7.14%) 
Peripheral sensory neuropathy * 1  2/286 (0.70%)  7/126 (5.56%) 
Psychiatric disorders     
Insomnia * 1  38/286 (13.29%)  10/126 (7.94%) 
Anxiety * 1  24/286 (8.39%)  9/126 (7.14%) 
Depression * 1  24/286 (8.39%)  4/126 (3.17%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  65/286 (22.73%)  20/126 (15.87%) 
Dyspnoea * 1  54/286 (18.88%)  19/126 (15.08%) 
Oropharyngeal pain * 1  28/286 (9.79%)  10/126 (7.94%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  78/286 (27.27%)  35/126 (27.78%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  4/286 (1.40%)  28/126 (22.22%) 
Rash * 1  29/286 (10.14%)  12/126 (9.52%) 
Dry skin * 1  14/286 (4.90%)  9/126 (7.14%) 
Vascular disorders     
Hot flush * 1  23/286 (8.04%)  9/126 (7.14%) 
1
Term from vocabulary, MedDRA v.20.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01945775    
Other Study ID Numbers: 673-301
C3441009 ( Other Identifier: Alias Study Number )
2013-002716-28 ( EudraCT Number )
U1111-1155-7579 ( Other Identifier: Universal Trial Number )
First Submitted: September 11, 2013
First Posted: September 19, 2013
Results First Submitted: September 5, 2018
Results First Posted: October 3, 2018
Last Update Posted: January 20, 2022