A Randomized Phase III Trial of Neoadjuvant Chemotherapy With 3 Cycles of FEC Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Adriamycin Plus Cyclophosphamide Followed by 4 Cycles of Docetaxel in Node-positive Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- pathologic complete response (pCR) between two arms
研究概览
简要总结
Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.
详细描述
To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Performance status 0 or 1
- •Clinically stage 2 or 3 with histologically proven lymph node involvement
- •Tumor or lymph node greater than 1.5 cm
排除标准
- •Pregnancy or lactation
- •Prior chemotherapy or radiotherapy for any malignancy
- •Documented history of cardiac disease contraindicating anthracyclines
- •Currently active infection
研究组 & 干预措施
FEC3-D3
3 cycles of FEC followed by 3 cycles of Docetaxel
Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks
Docetaxel 75 mg/m2, every 3 weeks
干预措施: FEC3-D3 (Drug)
结局指标
主要结局
pathologic complete response (pCR) between two arms
时间窗: within the first 30 days (plus or minus 3 days) after surgery
次要结局
- 3 year-disease free survival between two arms(3 year after surgery)
研究者
Sung-Bae Kim
Professor
Asan Medical Center