breast cancer
Conditions
Interventions
Combination chemotherapy consists of TS-1 (65-80 mg/m2/day, day 1 through 14), Lapatinib (1250 mg/day, day 1 through 21). Cycles are repeated every 3 weeks.
Sponsors
Tokai University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed breast cancer with metastatic disease 2) age: >=20 and <=75 3) Her2 positive 4) Performance Status: 0-1(ECOG) 5) sufficient function of important organs a) WBC: >=3,000/mm3 b) Neutrophyl: >=1,500/mm3 c) Platelet: >=100,000/mm3 d) Hemoglobin: >=9.0g/dl e) sT.bil: <= 1.5 times of the upper limit of normal range in each institute f) ALT, AST: <= 2.5 times of the upper limit of normal range in each institute g) Ccr: >=60 ml/min/body 6) left ventricular ejection fraction: normal range in institute 7) with ability of oral intake 8) written informed consent
Exclusion criteria
Exclusion criteria: 1) with active double cancer 2) with severe complications (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat, history of cerebrovascular accident, hemorrhagic gastrointestinal ulceration, uncontrolled diabetes, renal failure, active hepatitis, liver cirrhosis) 3) possible infection associated with clinical symptoms such as fever 4) uncontrolled pleural effusion, pericardial effusion 5) pregnant or nursing women or women who like be pregnant 6) with pulmonary fibrosis or pneumonitis 7) with history of mental disorder or treating it at the moment 8) with history of severe allergy 9) with severe allergy to TS-1 and Lapatinib 10) patients receiving Flucytosine 11) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determinate maximum tolerated dose and recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of TS-1, safety | — |
Countries
Japan
Contacts
Public ContactYasuhiro Suzuki
Tokai University School of Medicine Division of Breast and Endocrine Surgery, Department of Surgery
Outcome results
None listed