Neoadjuvant study of niraparib in patients with HER2-negative, BRCA-mutated, resectable breast cancer
Laura M. Spring, Hyo S. Han, Minetta C. Liu, Erika Hamilton, Hanna Y. Irie, Cesar A. Santa‐Maria, James A. Reeves, Peng Pan, Ming Shan, Yongqiang Tang, Julie R. Graham, Sebastien Hazard, Leif W. Ellisen, Steven J. Isakoff
Abstract
This single-arm pilot study (NCT03329937) evaluated neoadjuvant niraparib antitumor activity and safety in patients with localized HER2-negative, BRCA-mutated breast cancer. Twenty-one patients received niraparib 200 mg once daily in 28-day cycles. After 2 cycles, tumor response (≥30% reduction from baseline) by MRI was 90.5% and 40.0% (6 of 15) of patients who received only niraparib (2-6 cycles) had pathological complete response; no new safety signals were identified. High niraparib intratumoral concentration was observed.