This study is testing the safety and effectiveness of the drug olaparib (Lynparza) vs. placebo in breast cancer patients with germline BRCA1/2 mutations and high-risk HER2 negative breast cancer.

The main purpose of this trial is to determine whether use of the drug olaparib (trade name Lynparza) improves Invasive Disease Free Survival (IDFS) for a period of up to 10 years in patients with triple negative breast cancer. Patients will be randomized 1:1 to receive olaparib or a placebo for a maximum of 12 months. Randomization will depend on:

• Hormone receptor status (ER and/or PgR positive/HER2 negative versus TNBC)
• Prior neoadjuvant (therapy used just before primary therapy) versus adjuvant chemotherapy (therapy to complement primary therapy)
• Prior platinum use for breast cancer

The primary testing requirements for this trial include ongoing physical and breast exams, breast MRI and mammograms (except for those with bilateral mastectomy) annually for 10 years.

Randomized, double-blind, parallel group, placebo-controlled, multi-center, phase III study to assess the efficacy and safety of olaparib vs. placebo as adjuvant treatment in patients with gBRCA 1/2 mutations and high-risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Non-metastatic primary invasive adeno of the breast that is either triple negative breast cancer or ER and/or PgR positive, HER2 negative. Documented germline mutation in BRCA1 or BRCA2 predicted deleterious or suspected deleterious (testing can be done on study). Surgery and at least six cycles in neoadjuvant or adjuvant treatment setting must be completed (antoracyclines, taxanes or the combination of both). Prior platinum as potentially curative treatment for prior cancer (e.g., ovarian) or as adjuvant or neoadjuvant treatment for breast cancer.

Intervention/treatment: Olaparib vs. placebo for a year after standard treatment