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NCT02034916 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT02034916: Clinical Trial Phase 2 study, sponsored by Pfizer.
NCT02034916 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02034916, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease: * Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression \> 8 weeks following the last dose of platinum; or * Cohort 2) Subjects who have received \> 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease
Primary Outcome
ORR: Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1). CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to less than (\<) 10 millimeter (mm) in short axis. PR: Greater than or equal to (\>=) 30 percent (%) decrease in sum of diameters of target lesions, compared to the sum at baseline. Res
Interventions
- DRUG talazoparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2013-12-13 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 2 |
Why NCT02034916 stopped before completion
NCT02034916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which talazoparib is the first listed.
NCT02034916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02034916 about?
NCT02034916 is a clinical study titled "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)". The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 bas...
What is the current status of trial NCT02034916?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2013-12-13. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT02034916?
The interventions under investigation include: talazoparib (DRUG).
Who is sponsoring clinical trial NCT02034916?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02034916's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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