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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 BRCA 1 Gene Mutation, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
431
Enrollment target
20
Study locations

NCT01945775 is a Phase 3 study of Breast Neoplasms and BRCA 1 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.

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The verdict

NCT01945775, a Phase 3 study of Breast Neoplasms and BRCA 1 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.

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

1,845 total trials

What the Registry Record Tells You About NCT01945775

The ClinicalTrials.gov registry entry for NCT01945775 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 431 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (24% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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, BRCA 1 Gene Mutation, BRCA 2 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.

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

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