Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer
TNBC - Triple-Negative Breast Cancer
About this trial
This is an interventional treatment trial for TNBC - Triple-Negative Breast Cancer focused on measuring three-negative Breast Cancer with germline BRCA-mutated
Eligibility Criteria
Inclusion Criteria: Women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer Histopathologically confirmed early or locally advanced three-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; ER and/or PR negative (not eligible for endocrine therapy): IHC nuclear staining ≤ 1% Tumor stage: II-III: Primary tumor size: ≥ 2cm ECOG score 0 ~ 1; Centrally confirmed BRCA1 or BRCA2 germline mutation; Eligible level of organ function Exclusion Criteria: Patients with metastatic breast cancer or bilateral breast cancer or inflammatory breast cancer; Participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, immunotherapy, biological therapy or tumor embolization; Previously received PARPi therapy; History of another primary malignancy; Confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia; Female patients who are pregnant or lactating; History of allergy to drugs in this study;
Sites / Locations
- JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort1: Epirubicin+Cyclophosphamide
Cohort2: Fluzoparib+Paclitaxel
2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is CR or PR: Epirubicin+Cyclophosphamide for 2 cycles Fluzoparib+Paclitaxel for 2 cycles
2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is SD: Fluzoparib+Paclitaxel for 4 cycles