CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,837 enrolled
Drug / intervention
Olaparib +1 moredrug
Likely dose
Olaparib 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02032823
NCT02032823Phase 3Active
CompareCT.gov

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

AstraZeneca·interventional·Posted Jan 10, 2014·Updated May 6, 2026

In Brief

A Phase 3 clinical trial evaluating Olaparib and Placebo for Breast Cancer. Active but no longer recruiting, targeting 1,837 participants across 698 sites in 24 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Australia, Austria, Belgium, Canada, China, France, Germany, Hungary, Iceland, Israel, Italy, Japan, Netherlands, Poland, Portugal, Puerto Rico, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
CollaboratorsBreast International Group, Frontier Science & Technology Research Foundation, Inc., NRG Oncology, Myriad Genetic Laboratories, Inc., The Breast Adjuvant Study Team, Merck Sharp & Dohme LLC

Timeline

Phase 3Active
2014201520162017201820192020202120222023202420252026202720282029
First PostedJan 10, 2014
Enrollment StartApr 22, 2014
Primary CompletionMar 27, 2020
Study CompletionMay 28, 2029
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 12.5 years ago

Interventions

Olaparibdrug

Patients will be administred olaparib orally twice daily (b.i.d.) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water

Placebodrug

Patients will be administred matching placebo. Two (2) tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water