Neoadjuvant Fluzoparib Combined With Camrelizumab in Germline BRCA-mutated HER2-negative Breast Cancer
- Sponsor
- Peking University People's Hospital
- Study ID
- NCT05576389
- Phase
- PHASE2
- Status
- Enrolling By Invitation
Conditions
- Germline BRCA-mutated HER2-negative Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Camrelizumab+Fluzoparib — DRUGFluzoparib：150mg was given orally twice daily Camrelizumab：200 mg IV drip on Day 1 of each cycle
Study Details
This study is an open-label, single-arm, multicenter clinical study. 94 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。
Key Dates
- Start date
- Oct 1, 2022
- Status verified
- Nov 2022
- Primary completion
- Apr 30, 2024
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 94 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Camrelizumab+Fluzoparib
Primary Outcome Measure
tpCR（ypT0/is ypN0） [ Time Frame: 6 months ]