A phase 2 study of nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000009733
- Lead Sponsor
- Hiroshima city hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) with history of cardiac dysfunction 2) with sever complications ex.)with incontrollable diabetes,with infection,hypertension, renal insufficiency, liver failure and mental disorder which become problem on clinical practice 3) during pregnancy or lactation 4) with active secondary malignancy (current secondary malignancy or other malignancy within 5 years) . 5) with bilateral breast cancer 6) with pulmonary fibrosis or pneumonitis 7) allergy of the nab-Paclitaxel, Epirubicin,Cyclophosphamide and Fluorouracil 8) with peripheral neuropathy 9) HBs antigen is positive 10) patients judged by the investigator as unfit to be enrolled in 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 response rate,safety