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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 : Active, not recruiting
First Posted : September 19, 2013
Results First Posted : October 3, 2018
Last Update Posted : October 4, 2018
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Data reported is based on the primary analysis date of 15-Sep-2017.

Reporting Groups
  Description
Talazoparib 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 53 cycles, each cycle was of 21 days).
Physician's Choice Treatment 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 53 cycles, each cycle was of 21 days).

Participant Flow:   Overall Study
    Talazoparib   Physician's Choice Treatment
STARTED   287   144 
Treated   286   126 
COMPLETED   0   0 
NOT COMPLETED   287   144 
On going                166                65 
Death                107                53 
Withdrawal by Subject                7                20 
Lost to Follow-up                7                6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) analysis population included all randomized participants.

Reporting Groups
  Description
Talazoparib 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 53 cycles, each cycle was of 21 days).
Physician's Choice Treatment 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 53 cycles, each cycle was of 21 days).
Total Total of all reporting groups

Baseline Measures
   Talazoparib   Physician's Choice Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 287   144   431 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.5  (11.61)   49.4  (12.12)   48.1  (11.80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      283  98.6%      141  97.9%      424  98.4% 
Male      4   1.4%      3   2.1%      7   1.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      31  10.8%      15  10.4%      46  10.7% 
Not Hispanic or Latino      210  73.2%      111  77.1%      321  74.5% 
Unknown or Not Reported      46  16.0%      18  12.5%      64  14.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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      12   4.2%      1   0.7%      13   3.0% 
White      192  66.9%      108  75.0%      300  69.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      52  18.1%      19  13.2%      71  16.5% 


  Outcome Measures

1.  Primary:   Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment   [ Time Frame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months) ]

2.  Secondary:   Percentage of Participants With Objective Response: Investigator Assessment   [ Time Frame: Baseline until radiologic progressive disease or death due to any cause (up to a maximum duration of 36.9 months) ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline until death due to any cause or study cut-off (up to a maximum duration of 36.9 months) ]

4.  Secondary:   Trough Plasma Talazoparib Concentrations   [ Time Frame: Predose on Day 1 of Cycle 2, 3 and 4 ]

5.  Secondary:   Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to a maximum duration of 36.9 months ]

6.  Secondary:   Number of Participants With Grade 3 or 4 Postbaseline Toxicities in Laboratory Parameters: Hematology   [ Time Frame: Baseline up to primary analysis study cut-off date (up to a maximum duration of 36.9 months) ]

7.  Secondary:   Number of Participants With Grade 3 or 4 Postbaseline Toxicities in Laboratory Parameters: Chemistry   [ Time Frame: Baseline up to primary analysis study cut-off date (up to a maximum duration of 36.9 months) ]

8.  Secondary:   Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs   [ Time Frame: Baseline up to primary analysis study cut-off date (up to a maximum duration of 36.9 months) ]

9.  Secondary:   Number of Participants Taking At-least One Concomitant Medication   [ Time Frame: Baseline up to primary analysis study cut-off date (up to a maximum duration of 36.9 months) ]

10.  Other Pre-specified:   Duration of Response (DOR): Investigator Assessment   [ 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) ]

11.  Other Pre-specified:   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) for Overall Duration (Averaged of Week 4 to 160)   [ Time Frame: Baseline, Week 4 up to Week 160 (Overall Duration) ]

12.  Other Pre-specified:   Time to Deterioration (TTD) in Global Health Status/Quality of Life (QOL)   [ Time Frame: Baseline up to a maximum duration of 36.9 months ]

13.  Other Pre-specified:   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)   [ Time Frame: Baseline up to a maximum duration of 36.9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01945775     History of Changes
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: October 4, 2018