Neoadjuvant Fluzoparib Combined With Camrelizumab in Germline BRCA-mutated HER2-negative Breast Cancer

This is an interventional treatment trial for Germline BRCA-mutated HER2-negative Breast Cancer Read More

Inclusion Criteria:

• Women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer
• Histopathologically confirmed early or locally advanced HER2-negative invasive breast cancer as defined by the ASCO/CAP guidelines while meeting the following conditions:

HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; Tumor stage: II-III; Primary tumor size: ≥ 1 cm Nodal Status: N0-3

• ECOG score 0 ~ 1;
• Centrally confirmed BRCA1 or BRCA2 germline mutation;
• At least one measurable lesion according to RECIST 1.1
• Eligible level of organ function

Exclusion Criteria:

• Patients with metastatic breast cancer or bilateral breast cancer;
• Patients with inflammatory breast cancer;
• Participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, bisphosphonate therapy, immunotherapy, biological therapy or tumor embolization;
• Previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other therapies against PD-1/PD-L1 inhibitors;
• Previously received PARP inhibitors;
• 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.)