Phase II study of Nab-paclitaxel plus S-1 followed by FEC as neoadjuvant chemotherapy for the operable breast cancer
Phase 2
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000017177
- Lead Sponsor
- Kitasato University Kitasato Institute Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 28
Inclusion Criteria
Not provided
Exclusion Criteria
1) History of hypersensitivity reaction 2) HER2 negative disease 3) Active double cancer 4) Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months, heart failure. 5) Severe mental disorder 6) Sever bone marrow suppression, renal dysfunction, liver dysfunction 7) Has watery diarrhea 8) Active infection or potentiality infection 9) History of hypersensitivity for albumin 10) Grade2 or grater peripheral neuropathy 11)Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant 12)Judged ineligible based on physicians' decision
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pathological complete response rate(ypT0/is ypN0)
- Secondary Outcome Measures
Name Time Method adverse event, quasi pathological complete response rate, response rate, rete of breast conserving surgery, biomarker of chemotherapy, disease free survival