About this trial
This study is an open-label, single-arm, multicenter clinical study. 64 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。
Eligibility criteria
Qualifiers
HER2 negative: IHC 0/1+or IHC2+with no amplification of ISH;
Primary tumor size: ≥ 1cm
Lymph node status: N0-3
Inflammatory breast cancer patients with measurable lesions (according to RECIST 1.1 standard)
Disqualifiers
Tumor related symptoms and treatment
Recurrent or metastatic breast cancer;
Participated in other drug trials or received any anti-tumor therapy, including endocrine therapy, bisphosphate therapy, immunotherapy, biological therapy, or tumor embolization, within 4 weeks prior to enrollment;
Previously received treatment for PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other PD-1/PD-L1 inhibitors;
Trial design
Treatments tested in this trial
- Camrelizumab+Fluzoparib
Treatment groups
Sponsors and collaborators
Peking University People's Hospital
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator