A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer

UMIN ID: UMIN000001408

Registered date:01/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 2008/09/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): S-1 80mg/m2 twice daily on days1-14 every 3 weeks. Trastuzumab 6mg/kg (First time 8mg/kg) i.v., every 3 weeks

Outcome(s)

• Primary Outcome: Response Rate
• Secondary Outcome: Safety Overall survial Progression free survival Time to treatment failure Biomarkers

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Gunma Breast Clinical Conference Study Group(GBCCSG)
• Source(s) of Monetary Support: None