BreastCancer
Conditions
Interventions
FEC followed by Docetaxel 75 mg/m2, IV, Day 1 Cyclophosphamide 600mg/m2, IV, Day 1 Every 21 days for 4 cycles
Sponsors
Kinki Multidisciplinary Breast Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Histologically proven female breast cancer who underwent complete surgical excision Incidence of axillary metastasis by lymph node dissection or sentinel node biopsy. Age >= 20 to =<70 ECOG PS 0-1 Within 16 weeks from surgery and can tart treatment within 2 weeks Patients were required to have &#8226;leukocyte >= 4000/mm3 or neutrophil >= 2000/mm3 &#8226;hemoglobin >= 10 g/dL &#8226;platelet count >= 100,000/ mm3 &#8226;total bilirubin =< 1.5 mg/dL &#8226;AST =< 2.5x the upper limit of normal &#8226;serum creatinine less than 1.5 mg/dL Sufficient organ function Written informed consent
Exclusion criteria
Exclusion criteria: Patients who have received any prior therapy (hormonal therapy, chemotherapy, etc.) Pregnant or lactation women History of hypersensitivity reaction to drugs formulated with polysorbate Distant metastasis Patients judged by the investigator to be unfit to be enrolled into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of planned treatment cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| toxicity Mean delivered treatment course Relative dose-intensity | — |
Countries
Japan
Contacts
Public ContactNorikazu Masuda
Kinki Multidisciplinary Breast Oncology Group Secretariat office
Outcome results
None listed