breast cancer
Conditions
Interventions
Combination chemotherapy consists of TS-1 (80 mg/m2/day, day 1 through 14), Trastuzumab (4 mg/kg for the initial dosing and 2 mg/kg for subsequent administration, day1, 8, 15). Cycles are repeated eve
Sponsors
Tokai University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed breast cancer who diagnosed 2) metastatic breast cancer 3) age: >=20 and <=75 4) Her2 positive 5) No-carry-over effect of prior treatment 6) patients with measurable region 7) Performance Status: 0-2(ECOG) 8) left ventricular ejection fraction: normal range in institute 9) sufficient function of important organs a) WBC: >=4,000/mm3, <=12,000/mm3 b) Neutrophyl: >=2,000/mm3 c) Platelet: >=100,000/mm3 d) Hemoglobin: >=9g/dl e) ALT, AST: < 2.5 times of the upper limit of normal range in each institute f) sT.bil: <= the upper limit of normal range in each institute g) sCreatinin: <= the upper limit of normal range in each institute h) Ccr: >=60 ml/min/body 10) expected more than 3 months survival from drug administration 11)written informed consent 12)with ability of oral intake
Exclusion criteria
Exclusion criteria: 1) with severe allergy to Trastuzumab and TS-1 and 5-FU based drug 2) with history of severe allergy 3) pregnant or nursing women 4) with wide liver metastasis or lymphangitic pulmonary metastasis with respiratory distress 5) with active double cancer 6) with cerebral metastasis 7) with metastatic lesions observed only in their bones 8) with uncontrollable heart failure, angina pectoris, congestive cardiac failure, history of myocardial infarction, abnormal cardiac rhythm which need to treat 9) uncontrolled diabetes 10) with pulmonary fibrosis or pneumonitis 11) with dyspnea at rest 12) with uncontrolled pleural effusion, peritoneal effusion, pericardial effusion 13) possible infection associated with clinical symptoms such as fever 14) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Step 1 part: safety, feasibility Step 2 part: response rate, safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Step 1: Pharmacokinetics of TS-1 Step 2: TTP, TTF, OS | — |
Countries
Japan
Contacts
Public ContactYasuhiro Suzuki
Tokai University School of Medicine Division of Breast and Endocrine Surgery, Department of Surgery
Outcome results
None listed