Phase II Neoadjuvant Trial of Capecitabine, Cyclophosphamide and Epirubicin for Patients With Axillary Lymph Node Positive Stage II-III Operable Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pathologic response rates (pCR)
研究概览
简要总结
This randomized phase II trial compared pathologic response rates (pCR) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and capecitabine-epirubicin-cyclophosphamide (XEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Females aged 18-70 with histologically proven, core-biopsied, Stage II-III invasive breast cancer
- •No distant disease
排除标准
- •Inadequate heart or liver or kidney function
研究组 & 干预措施
FEC
Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.
干预措施: fluorouracil (Drug)
FEC
Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.
干预措施: cyclophosphamide (Drug)
FEC
Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.
干预措施: Epirubicin (Drug)
XEC
Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery.
干预措施: capecitabine (Drug)
XEC
Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery.
干预措施: cyclophosphamide (Drug)
XEC
Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery.
干预措施: Epirubicin (Drug)
结局指标
主要结局
pathologic response rates (pCR)
时间窗: The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 weeks.
The absence of invasive tumor in the final surgical breast sample (stage yT0 or ypTis)
次要结局
- DFS(Disease free survial)(Participants will be evaluated on Day 1 of each cycle during chemotherapy, and Day 1 every 3 months after completion of chemotherapy. The expected average of 5 years.)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Hematologic, renal, and hepatic funcion will be assessed after each cycle and at the end of therapy, an expected average of 3 weeks.)
研究者
Jianlun Liu
Director of Department of Breast Surgery
Guangxi Medical University