A phase II neoadjuvant trial of sequential weekly nab-paclitaxel(nanoparticle albumin-bound paclitaxel) (abraxane) in HER2-negative patients, followed by 5-fluorouracil/ epirubicine/ cyclophosphamide (FEC) in operable breast cancer
Phase 2
Recruiting
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000017033
- Lead Sponsor
- Tokyo Women's Medical University Department of Surgery II
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 42
Inclusion Criteria
Not provided
Exclusion Criteria
1)History of drug-hypersensitivity. 2) Evaluated HER2(+) by IHC/FISH. 3) Active double cancer. 4)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS) 5) Male patient. 6) Infection or suspected infection. 7) Abnormal ECG or serious cardiac disorder. (1)History of congestive cardiac failure.(NYHA class III/IV)) 8) Complication needed hospitalization. 9) Mental disease with difficulty of taking part in this study. 10) Administration of steroid. 11) HBV related marker (+). 12)Gastrointestinal bleeding. 13)Current pregnancy and lactation, or possibility of pregnancy. 14)Ineligible based on decision of an investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pathological Complete Response (pCR)
- Secondary Outcome Measures
Name Time Method Response Rate (RR) Safety