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COMPLETED Phase 3

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

NCT01945775 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 431 participants
Start Date 2013-10-14
Est. Completion 2021-03-05
Phase Phase 3

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01945775

The ClinicalTrials.gov registry entry for NCT01945775 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 431 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01945775 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01945775?

The interventions under investigation include: talazoparib (DRUG), Physician's-Choice (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01945775?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial