Breast Cancer
Conditions
Interventions
Docetaxel 75 mg/m2, IV, Day 1 Cyclophosphamide 600mg/m2, IV, Day 1 Every 21 days for 6 cycles
Sponsors
Kinki Multidisciplinary Breast Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion criteria: Histologically proven female breast cancer who underwent complete surgical excision No incidence of axillary metastasis by lymph node dissection or sentinel node biopsy Age >= 20 to =<34 or >=35 to =<70 who fills one of the followings (St.Gallen category of node-negative with intermediate risk) Tumor size >2cm Histologic and / or nuclear grade2-3 Presence of peritumoral vascular invasion HER2 IHC (3+) or FISH (+) ER (-) ECOG PS 0-1 No more than 2 weeks from the lastsurgery Patients were required to have leukocyte >= 4000/mm3 or neutrophil >= 2000/mm3 hemoglobin >= 10 g/dL platelet count >= 100,000/ mm3 total bilirubin =< 1.5 mg/dL AST =< 2.5x the upper limit of normal serum creatinine less than 1.5 mg/dL Sufficient organ function Written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Planned treatment completion rate | — |
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