Breast Cancer
Conditions
Interventions
(FEC100) Fluorouracil(500mg/m2) day1 Epirubicin(100mg/m2) day1 Cyclophosphamide(500mg/m2) day1 every 3weeks x 4cycles. (weekly nab-Paclitaxel) nab-Paclitaxel(100mg/m2) day1,8,15 (HER2 positiv
Sponsors
Department of Surgery Kurume University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)No prior treatment for breast cancer and clinical stage T1-3,N0-2,M0 2)Written informed consent to participate 3)Suitable judgement by physician 4)Histological and/or cytological confirmed breast cancer 5)Age 20 or over 6)Performance status (ECOG) 0-1 7)The below criteria met within 14 days prior to therapy 1 WBC between 4,000/mm3 and 12,000/mm3 2 Granulocyte count 2,000/mm3 or more 3 Platelet count 100,000/mm3 or over 4 Hb 9.0 g/dl or more 5 AST and ALT ULNx2.0 or less 6 Total bilirubin 1.5 mg/dL or less 7 Serum creatinine 1.5 mg/dl or less 8 ECG normal 9 Left ventricle ejection fraction 55 % or more by cardiac sonography or MUGA scan
Exclusion criteria
Exclusion criteria: 1)Heart failure with clinically problem or history of cardiac dysfunction 2)Severe complication (uncontrolled diabetes, hypertension, renal failure, hepatic failure, Severe Infection and mental disorder which become problem on clinical practice) 3)Pregnancy and lactation or suspected pregnancy 4)Active secondary malignancy (current secondary malignancy or other malignancy within 5 years) 5)Bilateral breast cancer 6)Pulmonary fibrosis or pneumonitis 7)Allergy of the nab-Paclitaxel, Epirubicin,Cyclophosphamide and Fluorouracil 8)Physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Preserving operation rate, Clinical response rate, Safety, etc. | — |
Countries
Japan
Contacts
Public Contactsame as above
Kurume University School of Medicine Department of Surgery
Outcome results
None listed