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

UMIN ID: UMIN000001414

Registered date:06/10/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Primary breast cancer
• Date of first enrollment: 2008/10/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): S-1 80mg/m2 b.i.d., day1-14 q3w, 1 yr

Outcome(s)

• Primary Outcome: Feasibility
• Secondary Outcome: Safety Overall survial Disease free survival Relative dose intensity Biomarkers

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Saitama Breast Cancer Clinical Study Group(SBCCSG)
• Source(s) of Monetary Support: None