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 ↗

Phase 3 Completed 302 enrolled AstraZeneca Merck Sharp & Dohme LLC · collab Myriad Genetic Laboratories, Inc. · collab

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

Outcome

Met primary endpoint

registry analysis (superiority test); Olaparib 300 mg bd vs Chemotherapy; p = 0.0009; Hazard Ratio (HR) 0.58 (95% CI 0.43 to 0.80); NCT02000622 ↗

release “AstraZeneca today presented positive results from its Phase III OlympiAD trial that showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for patients” astrazeneca.com ↗

release “In addition to meeting its primary endpoint of PFS assessed by blinded independent central review (BICR)” astrazeneca.com ↗

Publications

Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. doi: 10.1056/NEJMoa1706450. Epub 2017 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
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