Clinical 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.
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-02-13 |
Study Overview
Brief 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.
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.
Conditions
Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Intervention / Treatment
- Drug: Olaparib
- Drug: Physician's choice chemotherapy
Other Study ID Numbers
- D0819C00003
- 2013-005137-20
Start Date (Actual)
2014-03-27
Primary Completion Date (Actual)
2016-12-09
Study Completion Date (Actual)
2025-12-23
Enrollment (Actual)
302
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-02-13 |
Study Overview
Brief 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.
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.
Conditions
Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Intervention / Treatment
- Drug: Olaparib
- Drug: Physician's choice chemotherapy
Other Study ID Numbers
- D0819C00003
- 2013-005137-20
Start Date (Actual)
2014-03-27
Primary Completion Date (Actual)
2016-12-09
Study Completion Date (Actual)
2025-12-23
Enrollment (Actual)
302
Study Type
Interventional
Phase
Phase 3