BRCA Mutated High Risk HER2 Negative Primary Breast Cancer Treatment Study
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 germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.
The purpose of this study is to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation for subjects with BRCA mutated, HER2 negative breast cancer. Subjects will get either olaparib or placebo, a pill that looks like the study drug but contains no medication. We hope that olaparib will decrease the chance of cancer coming back as compared to the placebo.
In order to participate you must meet the following criteria:
- Have at least 6 cycles of anthracycline and/or taxane in the neoadjuvant or adjuvant setting.
- Register within 8 weeks of completing last standard treatment (surgery, chemo, or radiotherapy).
- Be at least 3 weeks out from receiving chemo and at least 2 weeks out from radiotherapy.
You will be excluded from the study if any of the following criteria apply to you:
- Have BRCA mutations that are considered non-detrimental.
- Have metastatic breast cancer.
- Have had whole blood transfusions within the last 120 days prior to BRCA testing for the study.
This is a partial list of inclusion and exclusion criteria.