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Testing the Drug Olaparib with a Placebo in Early Breast Cancer


Recruiting | Phase III

Official Title: 

A Randomized, Double-Blind, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib versus Placebo as Adjuvant Treatment in Patients with Germ-line BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

Study Purpose: 

To determine if the addition of olaparib (after usual care of chemotherapy, surgery, and radiation) will prevent or lengthen the amount of time to recurrence.


  • Targeted Therapy: Olaparib (Lynparza) or Placebo  
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM I: Olaparib 300 mg oral pill daily x 1 year
  • ARM II: Placebo oral pill daily x 1 year

After completion of study therapy, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.

Key Participation Requirements




19 years and older


BRCA 1 or 2 positive breast cancer patients who have had surgery and whose cancer also has additional higher risk features (i.e. – positive lymph nodes, high grade, large size, and/or triple negative marker status) NOTE: If treatment is not covered by insurance, BRCA testing can be done through the study.

Marker Status: 

Must be Her2 negative, all ER/PR statuses are accepted

Prior Therapy: 

Patients must have had surgery and completed chemotherapy (before or after surgery). They may or may not have had radiation. If appropriate, patients are allowed to be on hormone therapy at the same time as the study medication.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:


For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!