NCT01655992终止3 期
A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.
详细描述
Comparing S1 generic(Tegafur，Gimeracil and Oteracil Potassium Capsules) With Capecitabine in Patients With Metastatic Breast Cancer.
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
- •Histologically confirmed breast cancer
- •Pretreated metastatic breast cancer not more than 2 lines chemotherapy
- •Have not been previously treated with capecitabine,oral fluracil
- •ECOG performance status of ≤ 1
- •Be female and ≥ 18 and ≤ 75 years of age
- •Have at least one target lesion according to the RECIST criteria 1.1
排除标准
- •Pregnant or lactating women
- •Have been treated with capecitabine
- •Evidence of CNS metastasis
- •History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
- •Abnormal laboratory values: hemoglobin < 10.0 g/dl, absolute neutrophil count < 1.5×10^9/L, platelet count < 100×10^9/L, serum creatinine > upper limit of normal (ULN), serum bilirubin > ULN, ALT and AST > 5×ULN, AKP > 5×ULN
- •Serious uncontrolled intercurrent infection
- •Life expectancy of less than 3 months
研究组 & 干预措施
S1 generic
Experimental
40mg／m2 bid four weeks on two weeks off
干预措施: S1 generic (Drug)
capecitabine
Active Comparator
2500mg／m2／day divided into twice two weeks on one week off
干预措施: capecitabine (Drug)
结局指标
主要结局
progression free survival
时间窗: 6 months
次要结局
- response rate(1.5 months)
- overall survival(12 months)
研究者
Xichun Hu
Vice Director of department of medical oncology
Fudan University
研究点 (1)
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