The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
606
Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2 Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2
Epirubicin = 75 mg/m2 per cycle Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2
Disease free survival at 3 years
Time frame: 3 years
Assess safety in both treatment arms at 3 years
Time frame: 3 years
Compare overall survival between the 2 treatment arms at 3 years
Time frame: 3 years
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