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.

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Metastatic
• BRCA 1 Gene Mutation
• BRCA 2 Gene Mutation

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2014-03-27
• Primary completion: 2016-12-09
• Completion: 2025-12-23
• First posted: 2013-12-04
• Last updated: 2026-02-13
• Results posted: 2017-12-22

Locations

171 sites across 19 countries: United States, Bulgaria, China, Czechia, France, Hungary, Italy, Japan, Mexico, Peru, Poland, Romania, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom