Role of Olaparib in HER2-Negative Metastatic Breast Cancer Under Study
Posted: Friday, January 19, 2018
Plans for the LUCY trial were presented at the 2017 San Antonio Breast Cancer Symposium (SABCS; Abstract OT3-04-04). The study, led by Karen Gelmon, MD, of the British Columbia Cancer Agency, in Vancouver, British Columbia, will provide data on the efficacy of olaparib in patients with HER2-negative metastatic breast cancer with a germline BRCA1 and/or BRCA2 (gBRCA) mutation in a real-world setting.
Olaparib is approved by the U.S. Food and Drug Administration for the treatment of patients with deleterious or suspected gBRCA-mutated ovarian cancer, but the OlympiAD trial showed the drug provided significant improvements in progression-free survival compared with chemotherapy in patients with breast cancer. Results from the LUCY trial may help to inform and guide clinical practice.
The primary objective of this phase IIIb open-label, single-arm trial is progression-free survival. The investigators plan to screen approximately 2500 patients across 180 sites in 17 countries to enroll 250 patients with the mutation. Secondary objectives include overall survival among other parameters. Eligible patients, older than age 18 with gBRCA-mutated HER2-negative metastatic breast cancer, will be treated until disease progression, unacceptable toxicity, or other discontinuation criteria.
