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A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673) Administered to Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer

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Trial Profile

A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673) Administered to Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Talazoparib (Primary)
  • Indications Advanced breast cancer; Carcinoma
  • Focus Therapeutic Use
  • Acronyms ABRAZO
  • Sponsors BioMarin Pharmaceutical; Medivation; Pfizer
  • Most Recent Events

    • 28 May 2020 Results (n=369) characterizing the relationship between talazoparib exposure and the most common grade > 3 hematopoietic adverse events (AEs) leading to dose modification pooled from the phase 2 (ABRAZO) and phase 3 (EMBRACA) trials published in the Journal of Clinical Pharmacology
    • 14 Dec 2019 Results (n=494) of pooled analysis of five trials (EMBRACA, NCT01945775; ABRAZO, NCT02034916; NCT01286987, NCT03042910 & NCT02921919) assessing safety of talazoparib in patients with avanced breast cancer, presented at the 42nd Annual San Antonio Breast Cancer Symposium.
    • 06 Sep 2019 Results of population pharmacokinetics of talazoparib in patients with advanced cancer published in the Journal of Clinical Pharmacology
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