Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 15 November 2017

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...

purpose

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
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.
Enrollment: 302
Actual Study Start Date: March 27, 2014
Estimated Study Completion Date: December 21, 2018
Primary Completion Date: December 9, 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Olaparib
- Active Comparator: Physician's choice chemotherapy

Category Value
Date last updated at source 23-Aug-17
Study type(s) Interventional
Expected enrolment 302
Study start date 27-Mar-17
Estimated primary completion date 09-Dec-16

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