Breast cancer
Conditions
Interventions
Lapatinib at a dose of 1250 mg daily. Capecitabine at a dose of 2000 mg per square meter of body-surface area in two divided doses on days 1 through 14 of a 21-day cycle.
Sponsors
Saitama Breast Cancer Clinical Study Group(SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed breast cancer 2) Diagnosed HER2 over expression (IHC score 3+ or FISH positive) in primary or metastatic site 3) Patients who received previous treatment with oral FU agents 4) 6 months apart from the previous trastuzumab administration in adjuvant or neoadjuvant 5) Case who passes from the final administering of FU agents one month when FU agents is dministered by pre-treatment 6) Case to whom metastasis to central nervous system is steady 7) ECOG PS 0 to 2 8) Possible to take orally 9) Required baseline laboratory parameters within 14 days before it registers AST <= 3.0 times ULN and ALT <= 3.0 times ULN Case where abnormal shadow is not admitted by chest image inspection (X rays of chest or CT) LVEF<=ULN(LVEF more than 50%) Ccr >= 50ml/min (Cockcroft-Gault model) Neu >= 1,500 / mm3 Plt >= 100,000/mm3 Hb >= 9.0g/dl 10) Age>=20 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Concomitant infectious disease 2) History of lung disease, pulmonary fibrosis 3) Uncontrollable complication heart disease 4) have hypersensitivity to lapatinib and capecitabine 5) During pregnancy or lactation 6) History of serious hypersensitivity to fluoropyrimidines 7) Patients who received previous treatment with oral fluoropyrimidines within 12 months 8)The patient who has the risk of the extension at QT intervals is a case who assumes that it consults the specialist, and the treatment of the examination is inapposite. 9) Present case to whom radiation therapy is enforced 10) Doctors decision for excluion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical benefit rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Overall response rate Progression free survival Time to treatment failure Biomarkers | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group(SBCCSG) Secretariat Division (Shintoshin Ladies' MammoClinic)
Outcome results
None listed