Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)
Phase 1
- Conditions
- Reccurent or metastatic breast cancer
- Registration Number
- JPRN-UMIN000000517
- Lead Sponsor
- Japan Breast Cancer Research Group (JBCRG)
- Brief Summary
DLT was grade 4 hematological toxicity and grade 3>= nonhematological toxicities. Recommended dose for phase II were CPT-11 100mg/m2, TS-1 80-120mg/day.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Prior chemotherapy with CPT-11, S-1 Diarrhea No lesion other than bone metastasis Brain metastasis Serious cardiac disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I:MTD, DLT, RD Phase II:Clinical response, Clinical efficacy
- Secondary Outcome Measures
Name Time Method Phase II:Adverse events, TTP, OS