Breast Cancer
Conditions
Interventions
4 cycles of nab-paclitaxel followed by 4 cycles of FEC Nab-paclitaxel nab-paclitaxel: 260mg/m2, iv, day 1 every 3 weeks FEC Epi-ADM 90 mg/m2 and CPA 600 mg/m2 iv,day 1 every 3 weeks
Sponsors
Hiroshima city hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed Breast cancer 2) Clinical T1-3, N0-2, M0 cases and expected to radical cure by operation and neoadjuvant chemotherapy 3) ER,PgR and HER2 statuses are confirmed by needle biopsy 4) Age between 20 and 70 years 5) has measurable region 6) No prior therapy for present primary breast cancer 7) ECOG performance status 0 to 1 8) Required baseline laboratory parameters (within 2 weeks before registration): WBC 12,000 /mm3> >= 4000 /mm3 Neu >= 2000 / mm3 Plt >= 100,000/mm3 Hb >= 10.0g/dl AST <= ULNx2.5 ALT <= ULNx2.5 T-Bil <= 1.5mg/dL Creatinin <=1.5 mg/dL ECG normal 9) Written IC Ccr <=50 ml/min
Exclusion criteria
Exclusion criteria: 1) with history of cardiac dysfunction 2) with sever complications ex.)with incontrollable diabetes,with infection,hypertension, renal insufficiency, liver failure and mental disorder which become problem on clinical practice 3) during pregnancy or lactation 4) with active secondary malignancy (current secondary malignancy or other malignancy within 5 years) . 5) with bilateral breast cancer 6) with pulmonary fibrosis or pneumonitis 7) allergy of the nab-Paclitaxel, Epirubicin,Cyclophosphamide and Fluorouracil 8) with peripheral neuropathy 9) HBs antigen is positive 10) patients judged by the investigator as unfit to be enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate,safety | — |
Countries
Japan
Outcome results
None listed