A Phase II Comparative Study of ABI-007 in Patients with Metastatic Breast Cancer.
Phase 2
- Conditions
- Metastatic breast cancer
- Registration Number
- JPRN-jRCT2080220890
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 192
Inclusion Criteria
No history of chemotherapy for metastatic breast cancer
No over-expression of HER2 by IHC or FISH
Exclusion Criteria
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 Progression free survival<br>RECIST
- Secondary Outcome Measures
Name Time Method Response rate, Time to treatment failure, Time to progression, Overall survival<br>RECIST, other.