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Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.

Phase 3
Conditions
Breast cancer
Registration Number
JPRN-UMIN000003969
Lead Sponsor
Department of Breast Surgery, Graduate School of Medicine, Kyoto University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
1930
Inclusion Criteria

Not provided

Exclusion Criteria

1) Active double cancer 2) Bilateral (synchronous or asynchronous) breast cancer, inflammatory breast cancer 3) A history of previous treatment with oral 5-fluorouracil derivatives for 2 weeks or longer (Patients who received intravenous 5-fluorouracil can be enrolled.) 4) Serious diarrhea 5) Serious complications 6) A history of myocardial infarction within the past 6 months, interstitial pneumonia, or allergy to fluoropyrimidine derivatives 7) Pregnant women, nursing women, or women who want to become pregnant 8) Patients judged to be unsuitable for enrollment in the study by their physicians

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Invasive Disease-free survival
Secondary Outcome Measures
NameTimeMethod
Overall survival Distant Disease-free survival Disease-free survival Safety
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