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Lead
Fudan University
Comparing S1 generic(Tegafur,Gimeracil and Oteracil Potassium Capsules) With Capecitabine in Patients With Metastatic Breast Cancer.
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)