Breast cancer
Conditions
Interventions
4 cycles of weekly Nab-paclitaxel followed by 4 cycles of EC100 weekly nab-Paclitaxel (HER2 negative) Nab-Paclitaxel(80mg/m2) day1,8,15, every 4 weeks (HER2 positive) Nab-Paclitaxel(80mg/m2)
Sponsors
Rakuwakai Otowa Hospital Breast oncology department
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Cytological confirmed breast cancer 2) Clinical Stage I-III B 3) Expected to radical operation of post chemotherapy 4) Has measurable region 5) Age 20 or over 6) No prior surgery, radiation, chemotherapy and endocrine therapy 7) Performance Status 0-1 8) Adequate function of important organs(within 14 days before registration) WBC >=4,000/mm3 Neutrophil >=2,000/mm3 Platelet >=10.0 x 104/mm3 Hemoglobin >=9.0g/dL AST <=100 IU/L ALT <=100 IU/L T-Bil <=1.5mg/dL Creatinin <=1.5mg/dL
Exclusion criteria
Exclusion criteria: 1) History of hypersensitivity reaction 2) Active double cander 3) Other severe complications, such as infections, diarrhea, uncontrolled angina, myocardial infarction within 6 months, heart failure. 4) Case of contraindication of this drug 5) Patients with peripheral nerve symptoms 6) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant 7) Judged ineligible based on physicians' decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, rate of breast conserving surgery, frequency and degree of adverse events, remains rate of peripheral neuropathy, QOL survey, Correlation of the QOL survey results and the pCR rate and the response rate | — |
Countries
Japan
Contacts
Public ContactShingo Sakata
Rakuwakai Otowa Hospital Breast oncology department
Outcome results
None listed