Metastatic Breast Cancer
Conditions
Keywords
capecitabine, Tegafur，Gimeracil and Oteracil Potassium Capsules
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.
Interventions
DRUGcapecitabine
2500mg／m2／day divided into twice two weeks on one week off
DRUGS1 generic
40mg／m2 bid four weeks on two weeks off
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| response rate | 1.5 months |
| overall survival | 12 months |
Countries
China
Outcome results
None listed