Randomized Phase II Study of Neoadjuvant Chemotherapy and Trastuzumab (Herceptin) for Operable Breast Cancer with Overexpression of HER2
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000000651
- Lead Sponsor
- Office for cordination of Herceptin trial
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1. Pregnant and nursing 2. Concomitant infectious disease 3. History of hypersensitivity to Cremophor EL(polyoxethylated castor oil) or polysorbate 4. Interstitual pneumonia or lung fibrosis 5. Hepatitis Virus B antigen positive 6. Diabetes Mellitus with uncontrolled status or insulin-therapy 7. Difficulty to participate because of mental disorder 8. Simultaneous double-cancer (exclude carcinoma in situ)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological CR (pCR) rate Definition: no evidence of residual cancer in axillary lymph node and no evidence of residual invasive cancer in breast
- Secondary Outcome Measures
Name Time Method Disease-Free Survival Adverse Events in neoadjuvant therapy PK study of Neoadjuvant Trastuzumab (10 patients of each arm) To evaluate predictive factors of pCR by cDNA array