Phase II trial of TS-1 plus Trastuzumab in patients with metastatic breast cancer
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000004764
- 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
- 30
Not provided
1) with severe allergy to Trastuzumab and TS-1 and 5-FU based drug 2) with history of severe allergy 3) pregnant or nursing women 4) with wide liver metastasis or lymphangitic pulmonary metastasis with respiratory distress 5) with active double cancer 6) with cerebral metastasis 7) with metastatic lesions observed only in their bones 8) with uncontrollable heart failure, angina pectoris, congestive cardiac failure, history of myocardial infarction, abnormal cardiac rhythm which need to treat 9) uncontrolled diabetes 10) with pulmonary fibrosis or pneumonitis 11) with dyspnea at rest 12) with uncontrolled pleural effusion, peritoneal effusion, pericardial effusion 13) possible infection associated with clinical symptoms such as fever 14) 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 Step 1 part: safety, feasibility Step 2 part: response rate, safety
- Secondary Outcome Measures
Name Time Method Step 1: Pharmacokinetics of TS-1 Step 2: TTP, TTF, OS