Breast Cancer
Conditions
Interventions
S-1 is administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day), depending on the BSA from days 1 to 14, which is followed by 7 days rest. Trastuzumab 6 m
Sponsors
Kitasato University Kitasato Institute Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histological and/or cytological confirmed breast cancer 2) HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods 3) ECOG performance status 0-2 4) Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan) 5) Age 20 or over 6) Adequate function of important organs (within 14 days before registaration) 1. WBC: >=4,000/mm3 2. Neutrophil: >=2,000/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. T-Bil <= 1.5mg/dL 6. AST <= ULN x 2.5 7. ALT <= ULN x 2.5 8. Creatinin <= 1.5mg/dL 9.Ccr: >=60mL/min 7) Expected survival time: more than 6 months 8) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity reaction 2) Sever bone marrow suppression, renal dysfunction, liver dysfunction 3) Received S-1 4) Inflammatory breast cancer 5) Active double cancer 6) With widespread liver metastases or with dyspnea in pulmonary lymphangitis 7) With brain metastasis 8) With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease 9) Insulin therapy or Uncontrolled diabetes 10) With pulmonary fibrosis or pneumonitis 11) With dyspnea at rest 12) With pleural effusion, ascites, pericardial effusion 13) Active infection or potentiality infection 14) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant 15) Judged ineligible based on physicians' decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, progression free survival | — |
Countries
Japan
Outcome results
None listed