A phaseI/II study of TS-1 and Docetaxel with Metastatic Breast Cancer patients resisting for Docetaxel
Phase 1
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000002064
- Lead Sponsor
- Department of Breast and Thyroid Surgery, Kawasaki Medical School
- Brief Summary
no registry
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
1) Concomitant malignancy 2) Patient with contraindicate TS-1 and TXT 3) Complications including severe heart disease 4) Patient with cardiac infarction within 6 months 5) Serious renal function disturbance 6) Patient with cirrhosis 7) Patient with dyspnea by pheumonitis and lung fibrosis 8) Patient with uncontrolled diabetia 9) Patient with infectious 10)Gravida and having will of pregnancy 11) Patient with chemical allergy 12) Unsuitable patients by doctors diagnosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Decide most tolerable dose and recommend dose of medicine Phase II: Response rate
- Secondary Outcome Measures
Name Time Method Phase I: Adverse events Phase II: Disease free survival time, all survival time and adverse events