A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to assess the efficacy and safety of Olaparib Monotherapy versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients with germline BRCA1/2 Mutations.
Breast Cancer Metastatic
Olaparib, Physician’s choice chemotherapy
18 Years - 99 Years
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Oct 2023 by AstraZeneca
Myriad Genetics - BRACAnalysis test for FDA Premarket Approval (PMA), Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
No locations available
Olaparib tablet 300mg bd po
Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.
|Active Comparator: Physician’s choice chemotherapy|
Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21
Drug: Physician’s choice chemotherapy
Investigators will declare one of the following regimens: • Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days • Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days • Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days