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NCT01945775 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
A Phase 3 study of Breast Neoplasms and BRCA1 Gene Mutation, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 431
- Enrollment target
- 20
- Study locations
NCT01945775: Completed Phase 3 study of Breast Neoplasms and BRCA1 Gene Mutation, sponsored by Pfizer.
NCT01945775 is a Phase 3 study of Breast Neoplasms and BRCA1 Gene Mutation that has completed, run by Pfizer. The registered enrollment target is 431 participants, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01945775, a Phase 3 study of Breast Neoplasms and BRCA1 Gene Mutation, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 431 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.
Primary Outcome
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 m
Conditions Studied
Interventions
- DRUG talazoparib
- DRUG Physician's-Choice
Study Locations (20)
California
- Kaiser Permanente Medical Center Lab Drawing Station - Antioch
- Kaiser Permanente Medical Center Lab Drawing Station - Antioch
- CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center - Bakersfield
- Kaiser Permanente Medical Center Lab Drawing Station - Fairfield
- St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare - Fullerton
- Kaiser Permanente Medical Center Lab Drawing Station - Gilroy
- Los Angeles Hematology Oncology Medical Group - Glendale
- Los Angeles Hematology Oncology Medical Group - Glendale
- Marin Specialty Care - Greenbrae
- Los Angeles Hematology Oncolgy Medical Group - Los Angeles
- Los Angeles Hematology Oncology Medical Group - Los Angeles
- Drug Management Only: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D. - Los Angeles
- Drug Management only: UCLA West Medical Pharmacy - Los Angeles
- UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D. - Los Angeles
- UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D. - Los Angeles
- UCLA West Medical Pharmacy, Attn: Steven L. Wong - Los Angeles
- UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D. - Los Angeles
Arizona
- Arizona Oncology Associates P.C. - NAHOA - Flagstaff
- HonorHealth - Scottsdale
- Virginia G. Piper Cancer Pharmacy - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 431 participants |
| Start Date | 2013-10-14 |
| Est. Completion | 2021-03-05 |
| Phase | Phase 3 |
What the finished NCT01945775 record still lists
NCT01945775 is an interventional study that assigns participants to a tested intervention. The registered 431 participants enrollment target is mid-sized for trials with a published cap, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (24% lower).
The record links to 3 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which talazoparib is the first listed.
NCT01945775 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01945775 about?
NCT01945775 is a clinical study titled "A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)". The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.
What is the current status of trial NCT01945775?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 431 participants. The study started on 2013-10-14. Estimated completion is 2021-03-05.
What conditions does trial NCT01945775 study?
This clinical trial studies the following conditions: Breast Neoplasms, BRCA1 Gene Mutation, BRCA2 Gene Mutation.
What interventions are being tested in trial NCT01945775?
The interventions under investigation include: talazoparib (DRUG), Physician's-Choice (DRUG).
Who is sponsoring clinical trial NCT01945775?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01945775 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01945775's enrollment target sits among peer trials
431 25th of 97 higher than 73 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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.
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