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
B-55
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

https://clinicaltrials.gov/ct2/show/NCT02032823

  • 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
Interventional
III
Kathy Seymour, BSN
630-646-6075
630-646-6110
630-646-6072