Breast cancer
Conditions
Interventions
As FEC regimen, 5-fluorouracil 500 mg/m2 iv, epirubicine 100 mg/m2 iv and cyclophophamide 500 mg/m2 iv every 3 weeks, repeated 4 cycles Docetaxel 75 mg/m2 iv every 3 weeks, repeated 4 cycles follow
Sponsors
Kyushu Breast Cancer Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. ECOG Performance status 0-1 2. positive HER2 protain (IHC) or over-expression of HER2 gene (FISH) 3. Sufficient organ function (e.g. bone marrow, cardiac, liver and renal) 4. Primary breast cancer patients pN0-3 who underwent curative mastectomy and lymph-node dissection including negative sentinel lymph nodes 5.Within 6 weeks after surgery 6. No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy for present primary breast cancer 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Clinical or radiological evidence of metastatic breast cancer 2. complication of the active other malignancies 3. Serious cardiac disfunction 4. Uncontrolled medical conditions 5. Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 6. Patients who are required concurrent treatment by corticosteroids except for premedication 7 .Severe psychiatric disorders 8. Pregnant or lactation women, or women with suspected pregnancy 9. History of hypersensitivity reaction to drug formulated with Polysorbate 80 10. Patients judged by the investigator to be unfit to be enrolled into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of the treatment according with the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Postponement rate as compared to planned treatment schedule Dose reduction rate as compared to planned doses of chemotherapeutic agents | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Kyushu Breast Cancer Study Group Executive office
Outcome results
None listed