A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)
NCT ID: NCT01655992
Last Updated: 2018-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
386 participants
INTERVENTIONAL
2012-01-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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S1 generic
40mg／m2 bid four weeks on two weeks off
S1 generic
40mg／m2 bid four weeks on two weeks off
capecitabine
2500mg／m2／day divided into twice two weeks on one week off
capecitabine
2500mg／m2／day divided into twice two weeks on one week off
Interventions
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capecitabine
2500mg／m2／day divided into twice two weeks on one week off
S1 generic
40mg／m2 bid four weeks on two weeks off
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xichun Hu
Vice Director of department of medical oncology
Principal Investigators
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Xi-chun Hu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan Univeristy Cancer Hospital
Locations
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Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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Fudan BR2012-09 CBCSG011
Identifier Type: -
Identifier Source: org_study_id
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