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.)