Clinical Trial of the Week: Treatment trial for patients diagnosed with germline BRCA1/2 mutations and high-risk HER2 negative breast cancer

Researchers at Main Line Health are participating in a phase III study that is testing the safety and efficacy of olaparib (Lynparza®) vs. placebo in patients with germline BRCA1/2 mutations and high-risk HER2 negative breast cancer and who’ve completed local treatment and neoadjuvant or adjuvant chemotherapy.

In this multi-site randomized trial, researchers seek to determine if olaparib improves invasive disease-free survival for a period of up to 10 years. Patients are randomized 1:1 to receive the drug or a placebo for up to 12 months.

Inclusion criteria:

  • Must have been diagnosed with breast cancer defined as either ER and PgR negative and HER2 negative (not eligible for anti-HER2 therapy), or ER and/or PgR positive, HER2 negative
  • Must have documented germline mutation in 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.

Study NSABP B55 is available at all Main Line Health acute care hospitals. The principal investigators are Albert DeNittis, MD, and Paul Gilman, MD. More information is available at https://www.mainlinehealth.org/research/clinical-trials/nsabp-b55.

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