OncRef

Clinical Trial: NCT02032823

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:AstraZeneca
Information Provided By:AstraZeneca
Last Update Posted:2026-07-14

Study Overview

Brief Summary

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

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

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Olaparib
  • Drug: Placebo

Other Study ID Numbers

  • D081CC00006
  • NSABP B-55
  • 2024-511096-15-00
  • 2013-003839-30

Start Date (Actual)

2014-04-22

Primary Completion Date (Actual)

2020-03-27

Study Completion Date (Estimated)

2029-05-28

Enrollment (Actual)

1837

Study Type

Interventional

Phase

Phase 3