Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPeking University People's Hospital

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

64 Participants
are divided into 1 treatment group

Sponsors and collaborators

Peking University People's Hospital

Lead sponsor

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Collaborator