HER2 positive breast cancer
Conditions
Interventions
4 cycles of nab-paclitaxel and trastuzumab followed by 4 cycles of FEC. Nab-paclitaxel(nab-paclitaxel: 260mg/m2, iv, day 1 every 3 weeks) Trastuzumab*(6mg/kg, iv, day1 every 3 weeks) *:4 mg/kg for
Sponsors
Department of gastroenterologic and breast surgery Kanazawa University,School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histological confirmed invasive breast cancer 2) Clinical stage T1-3, N1-3, M0 3) With evaluable tumor lesions 4) HER2 positive (IHC 3+ or IHC2+, FISH +) 5) Age 20 to 75 6) No prior surgery, radiation, chemotherapy and endocrine therapy 7) ECOG performance status 0 - 1 8) preserving the functions of bone marrow, heart, liver, and kidney granulocyte count 1,500 / mm3 or more Platelet 100,000/mm3 or more Hb 9.0g/dl or more AST(GOT) less than 2.5-times the upper limit of normal ALT(GPT) less than 2.5-times the upper limit of normal Total-bilirubin 1.5 mg/dL or less serum creatinine 1.5 mg/dL or less 9) Signed informed consent of the patient for the registration.
Exclusion criteria
Exclusion criteria: 1) Allergy of the nab-Paclitaxel, Epirubicin,Cyclophosphamide and Fluorouracil 2) Active secondary malignancies 3) Bilateral invasive breast cancer 4) Severe complications (infection, diarrhea, paresis of intestine, obstruction of the intestines, uncontrolled diabetes mellitus, etc.) 5) Positive for HBs antigen and the history of HBV infection 6) Severe heart disease, or the patient who has past history of it 7) Severe mental disease or under treatment 8) Active gastrointestinal tract ulcer or bleeding 9) Severe bone marrow suppression, renal dysfunction, and liver dysfunction 10) Severe pleural effusion or ascites 12) Pregnancy or suspected pregnancy 13) Physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate Histological effect Breast preserving operation rate Frequency of side effects | — |
Countries
Japan
Outcome results
None listed