Feasibility study of S-1 as additional therapy after neo-adjuvant or adjuvant chemotherapy for triple negative breast cancer(SBCCSG-14).

Phase 2

• Conditions: Primary breast cancer

• Registration Number: JPRN-UMIN000001414
• Lead Sponsor: Saitama Breast Cancer Clinical Study Group(SBCCSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-06
• Study Completion: 2015-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1) Either of ER, PgR, HER2 is positive by surgical specimen. 2) Male breast cancer 3) Severe complications (uncontrolled diabetes mellitus, infection, heart failure which needs medical treatment (unstable angina pectoris, history of myocardial infarction occurred within 6 months), mental disorder) 4) Interstitial lung disease, pulmonary fibrosis 5) History of serious drug allergy 6) Active other malignancies 7) During pregnancy or lactation 8) History of hypersensitivity 9) History of serious hypersensitivity to fluoropyrimidines 10) During administration of fluoropyrimidines 11) During administration of flucytosine 12) Patients judged inappropriate by physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified