metastatic breast cancer
Conditions
Interventions
Lapatinib is administered intravenously at one hour before or after meal of day 1. S-1 is administered orally for 14 consecutive days followed by a 7 days rest. Cycles are repeated every 3 weeks.
Sponsors
St. Luke's International Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.histologically confirmed breast cancer 2.patients diagnosed as metastasisbreast cancer 3.HER2 status was considered positive(grade 3+ staining intensity by means of immunohistochemical analysis or grade 2+ staining intensity by means of immunohistochemical analysis with gene amplification on fluorescence in situ hybridization) 4.anthracycline, taxane and trastuzumab refractory patients 5.patients with evaluable region 6.20 years old or more 7.sufficient function of important organs Hemoglobin:over9g/dl WBC: over 4000/mm3 and under 12000/mm3 Neutrophyl:over 2000/mm3 Platelet: over 100000/mm3 T.bil: 2.0 times of normal range in institute GOT,GPT: 2.0 times of normal range in institute Left ventricular systolic dysfunction:normal range in institute serum Creatinin:normal range in institute Ccr:over 50 ml/min/body 8.Performance Statues: 0-2(ECOG) 9.with ability of oral intake 10.written informed consent
Exclusion criteria
Exclusion criteria: 1.with severe allergy to S-1 or Lapatinib 2.with active double cancer 3.infection,diarrhea,paralysis of intestine and intestinal obstruction which are judged to interfere with treatment,diabetes with incontrollable,and other sever complications 4.with mental disorder which become problem on clinical practice 5.with heart disease which become problem on clinical practice 6.with interstitial pneumonitis or with history of interstitial pneumonitis 7.with heart failure or with history of heart failure 8.with sever bone-marrow suppression, renal disorder,liver disorder 9.with large pleural effusion, or accumulation of ascitic fluid 10.with water diarrhea at the registration 11.treatment with flucytosine 12.pregnant,women who like be pregnant 13.doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate MTD and RD | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, rate of adverse events | — |
Countries
Japan
Contacts
Public ContactYoshida Atsushi
St. Luke's International Hospital Breast center
Outcome results
None listed