breast cancer
Conditions
Interventions
4 cycles of weekly Nab-paclitaxel followed by 4 cycles of FEC100 weekly nab-Paclitaxel (HER2 negative) Nab-Paclitaxel(80mg/m2) day1,8,15, every 4 weeks (HER2 positive) Nab-Paclitaxel(80mg/m2)
Sponsors
Kitasato University Kitasato Institute Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Cytological confirmed breast cancer 2) Clinical Stage I-IIIB 3) Expected to radical cure by operation and neoadjuvant chemotherapy 4) Has measurable region 5) Age 20 or over 6) No prior surgery, radiation, chemotherapy and endocrine therapy 7) Adequate function of important organs (within 14 days before registaration) 1. WBC: >=4,000/mm3 2. Neutrophil: >=2,000/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. T-Bil <= ULN x 2.5 6. AST <= ULN x 1.5 7. ALT <= ULN x 1.5 8. Creatinin <= 1.5mg/dL 8) ECOG performance status 0-1 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity reaction 2) Active double cancer 3) Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months, heart failure. 4) Severe mental disorder 5) Sever bone marrow suppression, renal dysfunction, liver dysfunction 6) Has watery diarrhea 7) Active infection or potentiality infection 8) History of hypersensitivity for albumin 9) Grade2 or grater peripheral neuropathy 10) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant 11) Judged ineligible based on physicians' decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event, quasi pathological complete response rate, response rate, rate of breast conserving surgery | — |
Countries
Japan
Outcome results
None listed