Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Phase 2
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000006020
- Lead Sponsor
- Tokai University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
past medical history of drug allergy HER2 positive breast cancer (IHC 3+, IHC 2+ and FISH +) Active double cancer Severe complications Symptomatic brain metastasis Severe mental disorder History of blood transfusions within 2 weeks Sever bone marrow suppression, renal dysfunction, liver dysfunction Body cavity fluid watery diarrhea on registration Active infection or potentiality infection allergic reaction of the nab-paclitaxel, paclitaxel or albumin During pregnancy or lactation Judged by the investigator to be unfit to be enrolled into the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pathological complete response rate
- Secondary Outcome Measures
Name Time Method adverse event clinical response rate pathological response rate rate of breast-conserving surgery feasibility overexpression rate of SPARC