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

Inclusion criteria

• 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;

Exclusion criteria

• 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;
• Previously received PARP inhibitor treatment (excluding those who have completed PARP inhibitor treatment for ovarian cancer for at least 5 years without recurrence or metastasis);
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis or combined hepatitis B and C co-infection; autoimmune hepatitis;
• Confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia; angina requiring antianginal medication
• Female patients who are pregnant or lactating
• History of definite neurological or psychiatric disorders, including epilepsy or dementia
• Presence of interstitial lung disease, pneumonitis, or uncontrolled systemic disease (eg, diabetes mellitus, pulmonary fibrosis, acute pneumonitis, etc.)