Olaparib as adjuvant treatment in patients with germline BRCA mutated high risk HER2 negative primary breast cancer - OlympiA

Study identifier:D081CC00006

ClinicalTrials.gov identifier:NCT02032823

EudraCT identifier:2013-003839-30

CTIS identifier:N/A

Recruitment Complete

Official Title

A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with gBRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Medical condition

Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Olaparib, Placebo

Sex

All

Actual Enrollment

1837

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 22 Apr 2014
Primary Completion Date: 27 Mar 2020
Estimated Study Completion Date: 28 May 2029

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Breast International Group, Frontier Science and Technology Research Foundation, Inc., NRG Oncology, Myriad Genetics - BRACAnalysis test for FDA Premarket Approval (PMA), Br.E.A.S.T. -Data Center & Operational Office Institut Jules Bordet, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Inclusion and exclusion criteria