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

Fudan University

Status and phase: Terminated; Phase 3

Conditions: Metastatic Breast Cancer

Treatments: Drug: S1 generic; Drug: capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01655992

Fudan BR2012-09 CBCSG011

Details and patient eligibility

About

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

Full description

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

Enrollment: 386 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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386 participants in 2 patient groups

S1 generic

Experimental group

Description:

40mg／m2 bid four weeks on two weeks off

Treatment:

Drug: S1 generic

capecitabine

Active Comparator group

Description:

2500mg／m2／day divided into twice two weeks on one week off

Treatment:

Drug: capecitabine