Breast cancer
Conditions
Interventions
Anthracycline followed by taxane Anthracyclin (1 or 2) 1) dose dense AC (ddAC)
Day1 Doxorubicin 60 mg/m2, Cyclophosphamide 600 mg/m2 Day3 Pegfilgrastim 3.6 mg every 2 weeks, 4 cycles 2) dose dense EC (ddEC)
Day1 Epirubicin 90 mg/m2, Cyclophosphamide 600 mg/m2, day 1 Day3 Pegfilgrastim 3.6 mg every 2 weeks, 4 cycles Taxane (3 or 4) 3) weekly Paclitaxel: Day1 Paclitaxel 80 mg/m2 weekly, 12 cycle
Sponsors
Mie University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Invasive ductal carcinoma 2. Stage I-III 3. Age >=20 and 75=< 4. ECOG PS 0 or 1 5. Vital organ functions are preserved 6. Written IC
Exclusion criteria
Exclusion criteria: 1. Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs) 2. History of drug-related allergy which could hinder planned treatment 3. Any history or complication of following cardiac disorders - History of congestive heart failure, cardiac infarction - Complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease 4. Poorly controlled hypertension 5. Poorly controlled diabetes 6. Pregnancy 7. Ineligible to the trial based on decision of an investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of treatment, safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival, overall survival, dose intensity, exploratory study to determine predictive factors of efficacy of dose dense chemotherapy | — |
Countries
Japan
Contacts
Public ContactHiroyasu Oda
Mie University Hospital Department of Oncology
Outcome results
None listed