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.

NCT02000622

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

EvaluationDrugModalityDoseRoute
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