The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy. Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,198
4 cycles, intravenous use, day 1 every three weeks
4 cycles, intravenous infusion, day 1 every three weeks
4 cycles, intravenous infusion, day 1 every three weeks after completion of EC-chemotherapy
6 cycles, intravenous infusion, day 1 every 3 weeks
6 cycles, intravenous infusion, day one every three weeks
Bethesda Krankenhaus
Mönchengladbach, Germany
disease-free survival in patients treated with either 6 cycles of Docetaxel / Cyclophosphamide chemotherapy or 4 cycles of EC followed by 4 cycles of Docetaxel as adjuvant treatment
Time frame: 5 years
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