PD-1 Inhibitor Sintilimab Concurrent With Epirubicin Cyclophosphamide and Nab-paclitaxel as Neoadjuvant Therapy for Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response (pCR)
研究概览
简要总结
The purpose of the study is to address the following hypotheses: the PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. This regimen will induce higher pathologic complete response (pCR) rate in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed histologically confirmed stage I-III, ER, PR and HER2 negative invasive breast cancer as defined by the ASCO CAP guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard NCCN practice guidelines.
排除标准
- •Patients for whom anthracycline, nab-paclitaxel or antibody therapies are contraindicated.
研究组 & 干预措施
Sintilimab
干预措施: Sintilimab (Drug)
结局指标
主要结局
Pathologic Complete Response (pCR)
时间窗: 21 weeks
Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0).
次要结局
未报告次要终点
研究者
Ying Lin
Vice Director
First Affiliated Hospital, Sun Yat-Sen University