Breast cancer
Conditions
Interventions
4 cycles of TC (Docetaxel 75 mg/m2 / Cyclophosphamide 600mg/m2), every 3 weeks
Sponsors
Kyushu Breast Cancer Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Primary breast cancer patients with negative HER2 excluded HER2 3+ by IHC3 or positive by FISH,and ER positive breast dancer. Intermediate risk for recurrence according to the classification proposed by the 10th International Symposium on Primary Therapy of Breast Cancer (St.Gallen, 2007) 2.ECOG Performance status 0-1 3.Within 6 weeks after surgery 4.No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy for present primary breast cancer 5.Sufficient organ function (e.g. bone marrow, cardiac, liver and renal) 6.Written informed consent
Exclusion criteria
Exclusion criteria: 1.History of bilateral breast cancer 2.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.HBs antigen positive 11.Treatment required pleural or pericardial effusions 12.Severe peripheral edema (>grade 1) 13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 14.Patients who are required concurrent treatment by corticosteroids except for premedication 15.Severe psychiatric disorders 16.Pregnant or lactation women, or women with suspected pregnancy 17.Patients judged by the investigator to be unfit to be enrolled into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| completion rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, disease-free survival | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Kyushu Breast Cancer Study Group Executive office
Outcome results
None listed