HER2 positive breast cancer
Conditions
Interventions
After enrollment, all patients receive preoperative treatment consisting of trastuzumab (4 mg/kg loading dose and then 2 mg/kg weekly for 11 weeks) and 260mg/m2
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed breast cancer 2) Clinical stage I-III 3) HER2 Overexpression (IHC 3+ or FISH +) 4) No prior treatment for breast cancer 5) Age more than 20 years and less than 75 years 6) ECOG performance status of 0 or 1 7) Required baseline laboratory parameters (within 14 days of registration) WBC: more than 3500 /mm3 Neu: more than 2,000 / mm3 Plt: more than 100,000/mm3 Hb: more than 9.0g/dl AST: less than 1.5 times UNL ALT: less than 1.5 times UNL T-Bil: less than 1.5 times UNL Cre: less than 1.5 times UNL 8) LVEF more than 55% 9) Written informed- consent
Exclusion criteria
Exclusion criteria: 1) During pregnancy or lactation 2) Previous (written 5 years) or current history of malignant neoplasm 3) Sever bone marrow suppression, renal dysfunction, and liver dysfunction . 4) Long-term corticosteroid therapy 5) Sever cardiovascular or pulmonary disease. 6) Drug allergy to nab-paclitaxel or paclitaxel and albumin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint : The pathological CR rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint : The clinical response rate, adverse event, breast conserving rate and relapse free survival. | — |
Countries
Japan
Contacts
Public ContactHiromitsu Jinno
Keio University School of Medicine Department of Surgery
Outcome results
None listed