A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)

A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.

Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.

Comparing S1 generic(Tegafur，Gimeracil and Oteracil Potassium Capsules) With Capecitabine in Patients With Metastatic Breast Cancer.

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

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