Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study
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。
• According to the definition of the latest ASCO/CAP guidelines, early or locally advanced HER2 negative invasive breast cancer confirmed by histopathology meets the following conditions:
‣ 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)
• Patients with bilateral breast cancer whose primary lesions all meet the inclusion criteria, or breast cancer with Tis-1bN0 and HER2 negative on the other side only meeting the inclusion criteria on one side;
• The hormone receptor status is known;
• ECOG score 0-1;
• Carrying BRCA1 or BRCA2 germline pathogenic mutations or suspected pathogenic mutations;
• According to RECIST 1.1 standard, at least one measurable lesion is present;