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trastuzumab plus epirubicin and cyclophosphamide followed by docetaxel (n=309) vs. lapatinib plus epirubicin and cyclophosphamide followed by docetaxel (n=311)
randomized controlled trial
trastuzumab plus epirubicin and cyclophosphamide followed by docetaxel
trastuzumab: IV 6 mg/kg body weight, every 3 weeks (loading dose of 8 mg/kg on day 1 of the first EC cycle) / epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 day 1, every 3 weeks / docetaxel: 100 mg/m2 day 1, every 3 weeks
lapatinib plus epirubicin and cyclophosphamide followed by docetaxel
lapatinib: 1,250 mg per day, starting on day 1 of the first cycle of EC until day 21 of the fourth cycle of docetaxel. Lapatinib was reduced to 1000mg per day to improve tolerability / epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 day 1, every 3 weeks / docetaxel: 100 mg/m2 day 1, every 3 weeks
All patients received four cycles of epidubicin and cyclophosphamide followed by four cycles of docetaxel.
es-BC - HER2 positive - (neo)adjuvant (NA)
open label
at 126 centres in Germany and one centre in Switzerland
P3 / pCR at 2-sided with alpha at 0.05 in the ITT population
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