Clinical Trial of the Week: Treatment trial for patients with germline BRCA 1/2 mutations and high-risk HER2 negative breast cancer

By Donna Loyle, communications specialist, LIMR

In this randomized, double-blind, multi-center study, researchers seek to determine if treatment with the drug olaparib (Lynparzaâ„¢) improves invasive disease-free survival for a period of up to 10 years in patients with triple negative breast cancer defined as either:

  • ER and PgR negative and HER2 negative, or
  • ER and/or PgR positive, HER2 negative

Participants in this Phase III study are randomized 1:1 to receive olaparib or a placebo for up to 12 months. Eligible participants must have documented germline mutation in the genes BRCA1 or BRCA2 that is known or predicted to be detrimental (leading to loss of function). Additionally, they must have completed breast and axilla surgery and at least six cycles of adjuvant or neoadjuvant chemotherapy (antoracyclines, taxanes or combination of both).

 

This trial is available at all Main Line Health acute care hospitals. Principal investigators are Albert DeNittis, MD, and Paul Gilman, MD. For more information, visit: https://www.mainlinehealth.org/research/clinical-trials/nsabp-b55.

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