A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Relapse-free survival
研究概览
简要总结
This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75
- •Performance status 0 or 1 (ECOG)
- •Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
- •Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ ULN
- •Renal Creatinine ≤ ULN
排除标准
- •Prior anticancer treatment
研究组 & 干预措施
1
UFT (uracil, tegafur)
干预措施: UFT (uracil, tegafur) (Drug)
2
CMF(cyclophosphamide, methotrexate, and fluorouracil)
干预措施: cyclophosphamide, methotrexate, and fluorouracil (Drug)
结局指标
主要结局
Relapse-free survival
时间窗: every course for first three courses, then every other course
次要结局
- Overall survival, adverse events, and the quality of life(any time)