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

NCT02032823 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1837

Last updated 2026-05-06

Study results available
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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

Conditions

Interventions

DRUG

Olaparib

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Breast International Group

    collaborator OTHER

  • Frontier Science & Technology Research Foundation, Inc.

    collaborator INDUSTRY

  • NRG Oncology

    collaborator OTHER

  • Myriad Genetic Laboratories, Inc.

    collaborator INDUSTRY

  • The Breast Adjuvant Study Team

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Andrew Tutt, Doctor of Medicine · Integrated Cancer Centre Guy's Hospital, King's College, London School of Medicine, London, UK

  • Judy Garber, Doctor of Medicine · Harvard Medical School, Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute, Susan F. Smither Center for Women's Cancers, 450 Brookline Avenue, Boston; MA 02215, US

  • Charles Geyer, Doctor of Medicine · Virginia Commonwealth University Massey Cancer Center, McGlothlin Medical Education Center, Room 12-217, 1201 East Marshall St., PO Box 980070, Richmond, VA 23298-0070, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-22
Primary Completion
2020-03-27
Completion
2029-05-28

Countries

  • United States
  • Argentina
  • 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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02032823 on ClinicalTrials.gov