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

July 20, 2016
Breast Cancer
Amaryllis Gil, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

To compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation, those with cancers sensitive to hormone treatment,  may receive hormone drugs.

Sponsor: NRG-Oncology

  • Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following:
    • Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative (not eligible for ani-HER2 therapy)
    • ER and/or PgR positive, HER2 negative
  • Documented mutation BRCA1 or BRCA2
  • Completed adequate breast and axillary surgery
  • Completed at least 6 cycles neoadjuvant chemotherapy containing anthracyclines, taxanes or combination of both
  • No previous treatment with PARP inhibitor, including olaparib
  • Cannot have a second primary malignancy
  • No evidence of metastatic breast cancer
10 years
Accepting Participants
Kathy Seymour, BSN