HER2-positive breast cancer
Conditions
Interventions
Nab-paclitaxl 260mg/mm2,q3w 6cycles Trastuzumab 8mg/kg loading dose over 90 min and 6mg/kg second dose over 60 min then 6mg/kg subsequent doses over 30 min,q3w total 6cycles
Sponsors
Tokyo Medical University Ibaraki Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed breast cancer 2)HER2 overexpression(IHC3+ or IHC2+ and FISH positive) 3) Clinical stage IIA, IIB, IIIA 4) Age >= 20 5) PS (ECOG) 0, 1 6) LVEF more than 55% 7) Adequate organ function 8) Baseline laboratory parameters (within 14 days of registration) Hemoglobin >= 9g/dL WBC >= 4000/mm3 Neutrophil >= 2000/mm3 Platelet >= 100000/mm3 AST, ALT <= ULN*2.5 T-Bil <= 1.5mg/dL Creatinine <= 1.5mg/dL 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women 2) Invasive cancer after completion of therapy(less than 5years ) 3) Asynchronous bilateral breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity Overall survival Relapse free survival | — |
Countries
Japan
Contacts
Public ContactKayoko Koshikawa
Tokyo Medical University Ibaraki Medical Center Department of breast surgery
Outcome results
None listed