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A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of Talazoparib (BMN 673) versus Physician's Choice in Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer, Who Have Received Prior Chemotherapy Regimens for Metastatic Disease

Trial Profile

A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of Talazoparib (BMN 673) versus Physician's Choice in Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer, Who Have Received Prior Chemotherapy Regimens for Metastatic Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Apr 2022

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At a glance

  • Drugs Talazoparib (Primary) ; Capecitabine; Eribulin; Gemcitabine; Vinorelbine
  • Indications Advanced breast cancer; Carcinoma; HER2 negative breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms EMBRACA
  • Sponsors BioMarin Pharmaceutical; Pfizer
  • Most Recent Events

    • 28 Jan 2022 Results published in the Clinical Cancer Research
    • 08 Jun 2021 Results assessing clinical characteristics of long and short responders presented at the 57th Annual Meeting of the American Society of Clinical Oncology.
    • 08 Jun 2021 The protocol was amended: in the case of a grade ≥3 anemia (<8g/dL), hemoglobin levels must return to grade 1 or meet study eligibility criteria (>9g/dL) before talazoparib could resume at a lower dose level.
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