Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.
Phase 2
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000002456
- Lead Sponsor
- Saitama Breast Cancer Clinical Study Group(SBCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical benefit rate
- Secondary Outcome Measures
Name Time Method Safety Overall response rate Progression free survival Time to treatment failure Biomarkers