Neoadjuvant Fluzoparib Combined With Chemotherapy in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer: an Open, Multicenter, Cohort Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- tpCR（ypT0/is ypN0）
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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；
研究组 & 干预措施
Cohort1: 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
干预措施: Fluzoparib+Paclitaxel (Drug)
Cohort1: 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
干预措施: Epirubicin+Cyclophosphamide (Drug)
Cohort2: Fluzoparib+Paclitaxel
2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is SD: Fluzoparib+Paclitaxel for 4 cycles
干预措施: Fluzoparib+Paclitaxel (Drug)
Cohort2: Fluzoparib+Paclitaxel
2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is SD: Fluzoparib+Paclitaxel for 4 cycles
干预措施: Epirubicin+Cyclophosphamide (Drug)
结局指标
主要结局
tpCR（ypT0/is ypN0）
时间窗: 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).
次要结局
- Event-free Survival (EFS) as assessed by Investigator(Up to approximately 3 years)
- AEs and SAEs(From enrollment to the surgery (approximately 6 months))
研究者
Liu Xiaoan
Professor
The First Affiliated Hospital with Nanjing Medical University