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

• Status: Terminated
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Capecitabine; Tegafur

Criteria

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