Randomized Phase II trial of Neoadjuvant weekly Nab-paclitaxel followed by FEC compared with Docetaxel followed by FEC for early breast cancer
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000005388
- Lead Sponsor
- Department of Breast Surgical Oncology, Showa University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 150
Not provided
1) History of sever hypersensitivity 2) Her 2 overexpression (3+ by IHC stain or 2+ and FISH positive) 3) Active other malignancies 4) Severe complications (infection, diarrhea, intestine on the paralyzed, and ileus which affect to treatment, uncontrolled diabetes mellitus, uncontrolled angina, heart infarction within 6 months, heart failure interstitial pneumonia or pulmonary fibrosis, cerebrovascular accident etc.) 5) has brain metastasis with symptoms 6) has psychological illness which became a problem in practice 7) received transfusion within 2 weeks because of bleeding in gastrointestinal tract 8) sever bone suppression, renal dysfunction, and liver dysfunction 9) sever pleural effusion or ascites fluid 10) water diarrhea at registration 11) has infection or fever which suspected of infection 12) history of hypersensitivity to Nab-paclitaxel, paclitaxel or albumin 13) pregnant or possibility of pregnant 14) history of sever hypersensitivity to docetaxel or polysorbate-containing product 15) Patients judged inappropriate by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is to evaluate the pathological CR rate.
- Secondary Outcome Measures
Name Time Method Secondary endpoint is to evaluate the Clinical response rate, pathological response rate, breast conserving rate, and safety.