BMN 673 in patients with metastatic breast cancer and a BRCA mutation

• Research type

  Research Study

• Full title

  A Phase 3, Open-Label, Randomised, Parallel, 2-Arm, Multi-Center Study of BMN 673 versus Physician’s Choice in Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer, Who Have Received No More than 2 Prior Chemotherapy Regimens for Metastatic Disease.

• IRAS ID

  140294

• Contact name

  Laura Kenny

• Contact email

  l.kenny@imperial.ac.uk

• Sponsor organisation

  BioMarin Pharmaceutical Inc.

• Eudract number

  2013-002716-28

• Clinicaltrials.gov Identifier

  NCT01945775

• Research summary

  Summary of Results

  The primary efficacy outcome was progression-free survival (PFS) according to Response Evaluaeria in Solid Tumors (RECIST) 1.1, as assessed by blinded independent central review. Ested median PFS was 8.6 and 5.6 months in the talazoparib and chemotherapy arms, respectively.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  14/LO/0344

• Date of REC Opinion

  3 May 2014

• REC opinion

  Further Information Favourable Opinion