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)
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date: March 27, 2014
Actual Primary Completion Date: December 9, 2016
Estimated Study Completion Date: December 31, 2019
Arms:
- Experimental: Olaparib
- Active Comparator: Physician's choice chemotherapy
| Category | Value |
|---|---|
| Date last updated at source | 2019-06-07 |
| Study type(s) | Interventional |
| Expected enrolment | 302 |
| Study start date | 2014-03-27 |
| Estimated primary completion date | 2016-12-09 |