Study ID: NSABP B55
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
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
- Must be 18 years or older
- Must have triple negative breast cancer defined as one of the following:
- ER and PgR negative and HER2 negative (not eligible for anti-HER2 therapy)
- ER and/or PgR positive, HER2 negative
- Must have documented germline mutation in the genes BRCA1 or BRCA2 that is known or predicted to be detrimental (leading to loss of function)
- Must have completed breast and axilla surgery, and at least six cycles of adjuvant or neoadjuvant chemotherapy
Additional criteria may apply.