The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 1
- 主要终点
- Relapse-free survival
研究概览
简要总结
This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. To evaluate the safety, data on adverse events will be collected during 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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 65
- •Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 11.0 g/dL
- •Hepatic AST and ALT ≤ 40 U/L Total bilirubin ≤ 1.5 mg/dL
- •Renal BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL
排除标准
- 未提供
研究组 & 干预措施
1
UFT (uracil, tegafur) and tamoxifen
干预措施: UFT (uracil, tegafur) and tamoxifen (Drug)
2
CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
干预措施: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen (Drug)
结局指标
主要结局
Relapse-free survival
时间窗: recurrence and survival will be collected for 5 years after surgery
次要结局
- Overall survival, adverse events, and the quality of life(adverse events will be collected during treatment)