Breast Cancer
Conditions
Interventions
ow-dose Nab-paclitaxel (HER2 negative) Nab-Paclitaxel(80mg/m2) day1,8,15, every 4 weeks (HER2 positive) Nab-Paclitaxel(80mg/m2) day1,8,15 Trastuzumab 2mg/kg day1,8,15,22 (4 mg/kg for the in
Sponsors
Kitasato University Kitasato Institute Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Cytological confirmed breast cancer 2) Unresectable or recurrence breast cancer 3) Has measurable region 4) Age 20 or over 5) 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 6) ECOG performance status 0-1 7) Life expectancy of at least 60 days after registration 8) 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 |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival,Time to treatment failure,Overall survival,Adverse event | — |
Countries
Japan
Contacts
Public ContactHirohito Seki
Kitasato University Kitasato Institute Hospital Breast Center
Outcome results
None listed