Breast cancer
Conditions
Interventions
4 cycles of FEC (Fluorouracil 500 mg/m2 / Epirubicin 75 mg/m2 / Cyclophosphamide 500mg/m2), every 3 weeks, then 4 cycles of Docetaxel 70 mg/m2 every 3 weeks.
Sponsors
Kyushu Breast Cancer Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically proven female breast cancer. 2)Clinical stage T 1-3 N 1-2 M0 3)Incidence of axillary metastasis by lymph node dissection or sentinel node biopsy. 4)> 19 to < 71 years old. 5)ECOG Performance status is 0-1 6)No more than 4 weeks since surgery. 7)No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy is allowed. 8)Sufficient organ function (e.g. bone marrow, cardiac, liver and renal) 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Bilateral breast cancer 2)A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix 3)Inflammatory breast cancer 4)Male 5)A history of hypersensitivity reaction to any drugs. 6)Uncontrolled medical conditions. 7)Suspected of infection with fever 8)Severe peripheral neuropathy (>Grade 1). 9)Symptomatic varicella. 10)Treatment required pleural or pericardial effusions 11)Severe peripheral edema. 12)Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 13)Patients who are required concurrent treatment by corticosteroids. 14)Severe psychiatric disorders 15)Pregnant or lactation women, or women with suspected pregnancy 16)Patients judged by the investigator to be unfit to be enrolled into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, feasibility | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Kyushu Breast Cancer Study Group Executive office
Outcome results
None listed