A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)
- Registration Number
- NCT01655992
- Lead Sponsor
- Fudan University
- Brief Summary
Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.
- Detailed Description
Comparing S1 generic(Tegafur，Gimeracil and Oteracil Potassium Capsules) With Capecitabine in Patients With Metastatic Breast Cancer.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 386
Inclusion Criteria
- 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
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Exclusion Criteria
- Pregnant or lactating women
- ECOG ≥ 2
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S1 generic S1 generic 40mg／m2 bid four weeks on two weeks off capecitabine capecitabine 2500mg／m2／day divided into twice two weeks on one week off
- Primary Outcome Measures
Name Time Method progression free survival 6 months
- Secondary Outcome Measures
Name Time Method response rate 1.5 months overall survival 12 months
Trial Locations
- Locations (1)
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China