Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Interventions
- Drug: Fluzoparib+PaclitaxelDrug: Epirubicin+Cyclophosphamide
- Registration Number
- NCT05834582
- Brief Summary
Although many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. 60 patients with germline BRCA-mutated three-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with chemotherapy according to tumor response after EC (epirubicin and cyclophosphamide) for 2 cycles.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
-
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
- 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；
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort1: Epirubicin+Cyclophosphamide Epirubicin+Cyclophosphamide 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 Cohort2: Fluzoparib+Paclitaxel Fluzoparib+Paclitaxel 2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is SD: Fluzoparib+Paclitaxel for 4 cycles Cohort2: Fluzoparib+Paclitaxel Epirubicin+Cyclophosphamide 2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is SD: Fluzoparib+Paclitaxel for 4 cycles Cohort1: Epirubicin+Cyclophosphamide 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
- Primary Outcome Measures
Name Time Method tpCR（ypT0/is ypN0） 6 months from the patients enrolled pCR is defined as the absence of invasive residual disease in the breast and in the axillary lymph nodes (ypT0/is ypN0).
- Secondary Outcome Measures
Name Time Method Event-free Survival (EFS) as assessed by Investigator Up to approximately 3 years EFS is defined as the time from enrollment to disease progression or death due to any cause
AEs and SAEs From enrollment to the surgery (approximately 6 months) adverse events and serious adverse events
Trial Locations
- Locations (1)
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China