Breast cancer
Conditions
Interventions
S-1 80mg/m2 twice daily on days1-14 every 3 weeks. Trastuzumab 6mg/kg (First time 8mg/kg) i.v., every 3 weeks
Sponsors
Gunma Breast Clinical Conference Study Group(GBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed breast cancer 2) Advanced or recurrence breast cancer with measurable lesions 3) Diagnosed HER2 over expression (IHC score 3+ or FISH positive) in primary or metastatic site 4) 6 months apart from the previous trastuzumab administration in adjuvant or neoadjuvant 5) No prior radiotherapy 6) Age 20 to 80 years 7) ECOG PS 0 to 2 8) Expected survival time: more than 3 months 9) LVEF more than 55% 10) Required baseline laboratory parameters WBC >= 3,500 /mm3 (or Neu >= 1,500 / mm3 ) and <= 12,000mm3 Plt >= 100,000/mm3 Hb >= 9.0g/dl AST <= 2.5 times ULN and ALT <= 2.5 times ULN T-Bil <= 1.5mg/dl Cre <= 1.2mg/dl or Ccr >= 60ml/min (Cockcroft-Gault model) 11) Written informed consent 12) Possible to take orally
Exclusion criteria
Exclusion criteria: 1) Male breast cancer 2) Necessary to continue treatment with warfarin potassium 3) Severe complications [ulcer which needs blood transfusion, uncontrolled diabetes mellitus, interstitial lung disease, pulmonary fibrosis, cerebral thrombosis, cerebral hemorrhage, subarachnoid hemorrhage, ischemia attack, encephalosis, stenocardia, myocardial infarction, uncontrolled congestive heart failure or arrhythmia, intestinal tract paralysis, ileus, neurodegeneration disease, hepatic insufficiency, cirrhosis, renal insufficiency] 4) Active double cancer 5) Inflammatory breast cancer or symptomatic brain metastasis 6) Patients who have only the lesion which caught the radiation exposure 7) Patients who received previous treatment with oral fluoropyrimidines within 12 months 8) internal use of flucytosyne 9) doctors decision for excluion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Overall survial Progression free survival Time to treatment failure Biomarkers | — |
Countries
Japan
Contacts
Public ContactJun Horiguchi
Gunma Breast Clinical Conference Study Group(GBCCSG) Secretariat Division (Department of Thoracic Visceral Organ Surgery , Gunma University Graduate Scho
Outcome results
None listed