A Phase I Study of weekly ABI-007 in Combination with TS-1 in Patients with Metastatic Breast Cancer
Phase 1
- Conditions
- Metastatic breast cancer
- Registration Number
- JPRN-jRCT2080221553
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
Patient has no prior chemotherapy or one for metastatic breast cancer. No prior chemotherapy of Taxanes or TS-1 for metastatic breast caner.
- Patient has no over-expressed HER2 for IHC or FISH.
Exclusion Criteria
- Patient has recurrent disease within 12 months following the end of neo-adjuvant or adjuvant chemotherapy with a Taxane-containing regimen.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>CTCAE (ver.4.0)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics, Efficacy<br>RECIST (ver.1.1)