Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer
Status:
Completed
Trial end date:
2020-03-31
Target enrollment:
Participant gender:
Summary
This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of
niraparib as neoadjuvant therapy in participants with Human epidermal growth factor receptor
2 (HER2)-negative and breast cancer susceptibility gene mutant (BRCAmut) localized breast
cancer (primary tumor >=1 centimeters [cm]). Breast magnetic resonance imaging (MRI), breast
ultrasound, and tumor core biopsy will be performed at the screening (Days -28 to -1).
Participants will receive niraparib (200 milligrams [mg] orally [PO]) treatment daily for 28
days (Cycle 1) and then will undergo breast ultrasound at the end of Cycle 1 on Day 28. Based
on breast ultrasound reports, the participants will either discontinue the study (disease
progression) or will continue niraparib treatment (complete response [CR], partial response
[PR] or stable disease [SD]) for an additional cycle (Cycle 2). A breast MRI and breast
ultrasound will be performed at the end of Cycle 2. Approximately 21 participants will be
enrolled in this study and the study duration will be approximately 2 years.