Assessment of the efficacy and safety of Olaparib Monotherapy versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients with germline BRCA1/2 Mutations. - OlympiAD
Study identifier:D0819C00003
ClinicalTrials.gov identifier:NCT02000622
EudraCT identifier:2013-005137-20
CTIS identifier:N/A
Recruitment Complete
Official Title
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.
Medical condition
Breast Cancer Metastatic
Phase
Phase 3
Healthy volunteers
No
Study drug
Olaparib, Physician’s choice chemotherapy
Sex
All
Actual Enrollment
302
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 27 Mar 2014
Primary Completion Date: 09 Dec 2016
Estimated Study Completion Date: 31 Dec 2024
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Myriad Genetics - BRACAnalysis test for FDA Premarket Approval (PMA), Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Olaparib Olaparib tablet 300mg bd po | Drug: Olaparib 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 |
Contacts
Investigators
Principal Investigator
Mark Robson
Memorial Sloan-Kettering Cancer Center, New York
