Breast Cancer
Conditions
Interventions
TS-1 (80 mg/m2/day) is administered orally on days 3-7, 10-15 and 17-21. CPT-11 (60mg/m2) is injected by vein on day1, 8 and 15. Trastuzumab (4 mg/kg for the initial dosing and 2 mg/kg for subsequent
Sponsors
Kurume University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Histological and/or cytological confirmed breast cancer 2.Metastatic breast cancer 3.HER2 positive (3+ staining by IHC or HER2 gene amplification by FISH) confirmed in the invasive component of the primary or metastatic lesion 4.age: >=20 and <80 5.Performance Status: 0-2 (ECOG) 6.The below criteria are met about prior therapy (1)chemotherapy: more than 7 days passed after chemotherapy (2)hormonal therapy: more than 7 days passed after hormonal therapy (3)radiation: more than 14 days passed after radiation. 7.expected survival longer than 3 months 8.With ability of oral intake 9.Sufficient function of important organs within 7 days prior to entry (1)WBC between 3,000/mm3 and 12,000/mm3 (2)Granulocyte count 1,500/mm3 or over (3)Platelet count 100,000/mm3 or over (4)Hb 9.0 g/dL or over (5)Total bilirubin <= the upper limit of normal range in each institute (6)AST(GOT) <=2.5 times of the upper limit of normal range in each institute (7)ALT(GPT) <=2.5 times of the upper limit of normal range in each institute (8)Serum creatinine <= the upper limit of normal range in each institute (9)Left ventricle ejection fraction 50 % or over by cardiac sonography or MUGA scan (10)Ccr: >=50 ml/min 10.Written informed consent to participate
Exclusion criteria
Exclusion criteria: 1.With contraindicate TS-1, CPT-11 and Trastuzumab 2.With active double cancer 3.With uncontrolled diabetes 4.Heart failure with clinically problem 5.Symptomatic brain metastasis 6.With mental disorder which become problem on clinical practice 7.With uncontrolled hypertension 8.Physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival(PFS) | — |
Countries
Japan
Contacts
Public ContactToh Uhi
Kurume University School of Medicine Department of Surgery
Outcome results
None listed