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
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 30 Nov 2017
At a glance
- Drugs Olaparib (Primary) ; Capecitabine; Eribulin; Vinorelbine
- Indications Advanced breast cancer; Male breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms OlympiAD
- Sponsors AstraZeneca
- 30 Nov 2017 According to a Merck AG media release, additional results from this trial as well as a subgroup analysis in Asian patients will be presented at the 2017 San Antonio Breast Cancer Symposium (SABCS).
- 23 Oct 2017 According to a Merck AG media release, based on the data from this study, the company has submitted a new drug application (NDA) to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the use of LYNPARZA (olaparib) tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018.
- 18 Oct 2017 According to a Myriad Genetics media release, the U.S. Food and Drug Administration (FDA) has accepted its supplementary premarket approval (sPMA) application for BRACAnalysis CDx to be used as a companion diagnostic with AstraZeneca's PARP inhibitor Lynparza (olaparib) in patients with HER2-negative metastatic breast cancer. Myriad's sPMA filing follows positive results from this study.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History