Randomized phase II study of preoperative systemic chemotherapy of carboplatin/weekly paclitaxel followed by CEF versus weekly paclitaxel followed by CEF for operable HER2-negative breast cancer
Phase 2
- Conditions
- Stage II and IIIA breast cancer
- Registration Number
- JPRN-UMIN000003355
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 220
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients during pregnancy or lactation 2) Active infectious disease 3) History of hypersensitivity for Cremophor® EL(polyoxethylated castor oil) 4) Interstitual pneumonia or lung fibrosis 5) HBs antigen positive 6) Uncontrolled diabetes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response rate, which is defined as the absence of viable invasive tumor in both the breast and the axillary nodes, or residual ductal carcinoma in situ (DCIS) in breast and no viable invasive tumor in the axillary nodes.
- Secondary Outcome Measures
Name Time Method 1) Disease-free survival 2) Clinical response rate 3) Adverse events 4) Breast-conservation rate