Overview

This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments capecitabine, s1 generic
Phase phase 3
Sponsor Fudan University
Start date January 2012
End date December 2016
Trial size 386 participants
Trial identifier NCT01655992, Fudan BR2012-09 CBCSG011

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
40mg/m2 bid four weeks on two weeks off
s1 generic Tegafur,Gimeracil and Oteracil Potassium Capsules
40mg/m2 bid four weeks on two weeks off
(Active Comparator)
2500mg/m2/day divided into twice two weeks on one week off
capecitabine Xeloda
2500mg/m2/day divided into twice two weeks on one week off

Primary Outcomes

Measure
progression free survival
time frame: 6 months

Secondary Outcomes

Measure
response rate
time frame: 1.5 months
overall survival
time frame: 12 months

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.
Principal investigator Xi-chun Hu, MD,PhD
Description Comparing S1 generic(Tegafur,Gimeracil and Oteracil Potassium Capsules) With Capecitabine in Patients With Metastatic Breast Cancer.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Fudan University.