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A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) (ABRAZO)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02034916
First Posted: January 14, 2014
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Myriad Genetic Laboratories, Inc.
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: September 1, 2017  
Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Neoplasms
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Intervention: Drug: talazoparib

  Participant Flow
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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
In this study, enrollment of participants was to be done in 2 stages for each of the two cohorts. Sufficient responses in each cohort were observed such that enrollment could proceed to Stage 2 for both cohorts. However, due to Sponsor decision, enrollment in the overall trial was terminated early.

Reporting Groups
  Description
Cohort 1: Talazoparib 1 mg Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 milligram (mg) orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Cohort 2: Talazoparib 1 mg Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.

Participant Flow:   Overall Study
    Cohort 1: Talazoparib 1 mg   Cohort 2: Talazoparib 1 mg
STARTED   49   35 
Treated   48   35 
COMPLETED   0   0 
NOT COMPLETED   49   35 
Death                32                13 
Withdrawal by Subject                1                1 
Lost to Follow-up                1                1 
Ongoing as of data cutoff (01 Sep 2016)                15                20 



  Baseline Characteristics
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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) population involved all enrolled participants including participants who were not treated.

Reporting Groups
  Description
Cohort 1: Talazoparib 1 mg Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Cohort 2: Talazoparib 1 mg Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Total Total of all reporting groups

Baseline Measures
   Cohort 1: Talazoparib 1 mg   Cohort 2: Talazoparib 1 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   35   84 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.1  (11.48)   53.4  (11.05)   51.5  (11.35) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      48  98.0%      34  97.1%      82  97.6% 
Male      1   2.0%      1   2.9%      2   2.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: From randomization until data cutoff date (01 Sep 2016) ]

2.  Secondary:   Clinical Benefit Rate-24 (CBR-24)   [ Time Frame: From randomization until data cutoff date (01 Sep 2016) ]

3.  Secondary:   Duration of Response (DOR)   [ Time Frame: From first documentation of CR or PR until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016]) ]

4.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From first dose of study drug until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016]) ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: From first dose of study drug until death due to any cause (up to the data cutoff date [01 Sep 2016]) ]

6.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016]) ]

7.  Secondary:   Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016]) ]

8.  Secondary:   Number of Participants With Outcome in Response to Adverse Events (AEs)   [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016]) ]

9.  Secondary:   Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameters   [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016]) ]

10.  Secondary:   Number of Participants With Clinically Significant Change From Baseline in Vital Signs   [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016]) ]

11.  Secondary:   Number of Participants With Clinically Significant Change From Baseline in Physical Findings   [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016]) ]

12.  Secondary:   Number of Participants With Atleast 1 Concomitant Medication   [ Time Frame: From first dose of study drug up to 30 days after the last dose or before initiation of a new anticancer treatment, whichever occurred first (up to the data cutoff date [01 Sep 2016]) ]

13.  Secondary:   Trough Concentration Versus Time Summary of Talazoparib   [ Time Frame: Predose on Day 1 of Cycle 1, 2, 3 and 4 ]

14.  Other Pre-specified:   Time to Deterioration in Global Health Status/Quality of Life (QOL) and Functional Status as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)   [ Time Frame: Baseline up to death, disease progression or end of treatment (30 days after last dose of study drug or before initiation of a new anticancer therapy, whichever occurred first [up to data cutoff date: 01 Sep 2016]) ]

15.  Other Pre-specified:   Time to Deterioration in Disease Specific Symptoms 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 death, disease progression or end of treatment (30 days after last dose of study drug or before initiation of a new anticancer therapy, whichever occurred first [up to data cutoff date: 01 Sep 2016]) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02034916     History of Changes
Other Study ID Numbers: 673-201
2013-003076-12 ( EudraCT Number )
C3441008 ( Other Identifier: Alias Study Number )
First Submitted: January 9, 2014
First Posted: January 14, 2014
Results First Submitted: September 1, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017