Postmenopausal, hormone-receptor positive and resectable primary breast cancer
Conditions
Interventions
Epirubicin 90-100 mg/m2, Cyclophosphamide 600 mg/m2, q3w x 4 cycles or Adriamycin 60 mg/m2, Cyclophosphamide 600 mg/m2, q3w x 4 cycles + Paclitaxel 80 mg/m2, weekly 12cycles and Letrozole 2.5mg p.o. d
Sponsors
Niigata Cancer Center Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Operable primary breast cancer(Stage2 ,3A at first diagnosis) 2.Postmenopausal patients who satisfies one or more below criteria; A,Prior bilateral oophorectomy B,>=60 years old < 70 years old C,< 60 years old and amenorrheic for 12 months or more and FSH , plasma estradiol level in postmenopausal ranges D,< 60 years old and after hysterectomy and FSH , plasma estradiol level in postmenopausal ranges 3.Measurable region 4.ER and/or PgR positive 5.PS 0-1(ECOG) 6.Adequate major organ function; WBC >= 3,000/mm3, <= 12,000/mm3 or ANC >= 2,000/mm3 PLT >= 100,000/mm3 Hb >= 9.5 g/dl GOT,GPT <=1.5 x ULN Total bilirubin <= 1.25 x ULN Serum creatinin <= 1.5 Cardiac function normal ECG 7.Patient judged appropriate for this study by the physicians 8.Written informed consent
Exclusion criteria
Exclusion criteria: 1.Serious complications ( e.g malignant hypertension, CHF, hepatic failure, MI within 6 months, PE, arrhythmia treatment needed, infection, hemorrhagic tendency ) 2.Hepatitis B 3.Serious Diabetes mellitus 4.Infection disease 5.Active multiple cancer 6.Edema 7.Inflammatory breast cancer 8.Synchronous bilateral breast cancer 9.History of drug-hypersensitivity 10.Patients have been treated with steroid or hormone replacement therapy or raloxifene 11.Mental disease 12.Osteoporosis, treated with bisphosphonate at present 13.Patient judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate,Breast Conserving Surgery rate,Safety | — |
Countries
Japan
Outcome results
None listed