Phase I trial of S-1 plus Lapatinib in patients with HER-2 positive metastatic breast cancer
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000004921
- Lead Sponsor
- Tokai University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 6
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method