Primary breast cancer
Conditions
Interventions
S-1 80mg/m2 b.i.d., day1-14 q3w, 1 yr
Sponsors
Saitama Breast Cancer Clinical Study Group(SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed primary breast cancer. 2) ER(-), PgR(-) and HER2(-) 3) Received primary systemic therapy. 4) Age more than 20years and less than 75 years. 5) ECOG performance status of 0 or 1. 6) Possible to take orally 7) Required baseline laboratory parameters (within 14 days before registration): WBC more than 4000 /mm3 Neu more than 2000 / mm3 Plt more than 100,000/mm3 Hb more than 9.0g/dl AST less than 2.5 times ULN ALT less than 2.5 times ULN T-Bil less than 1.5mg/dl Cre less than 1.2mg/dl Ccr more than 60ml/min 8) Signed informed consent of the patient for the registration.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Overall survial Disease free survival Relative dose intensity Biomarkers | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group(SBCCSG) Secretariat Division (Shintoshin Ladies' MammoClinic)
Outcome results
None listed