drugset / Trial / NCT02000622
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.
Phase 3
Completed
302 enrolled
AstraZeneca
Merck Sharp & Dohme LLC · collabMyriad Genetic Laboratories, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-03-27
- Primary completion
- 2016-12-09
- Completion
- 2025-12-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 2500 mg/m2 | Oral |
| Comparator | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Comparator | Vinorelbine | Small molecule | 30 mg/m2 | Intravenous |