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

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Investigator: Hope Rugo, MD
Sponsor: BioMarin Pharmaceutical, Inc.

Location(s): United States

Description

The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

  • Cohort 1) Subjects who have previously responded to platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or
  • Cohort 2) Subjects who have received > 2 chemotherapy regimens and who have had no prior platinum therapy for metastatic disease