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docetaxel plus carboplatin with trastuzumab followed by trastuzumab (n=1075) vs. doxorubicin plus cyclophosphamide followed by docetaxel (n=1073)
randomized controlled trial
docetaxel plus carboplatin with trastuzumab followed by trastuzumab
docetaxel 75mg per square meter plus carboplatin AUC 6mg/mL per minute, every 3 weeks for 6 cycles / trastuzumab: for 1 year beginnig with the first dose of docetaxel, initiailly administered at a dose of 4mg per kg of body weight, followed by 2mg per kg per week during chemotherapy and then 6mg per kg every 3 weeks to complete 1 year of trastuzumab treatment
doxorubicin plus cyclophosphamide followed by docetaxel
doxorubicin: 60mg per square meter every 3 weeks for four cycles / cyclophosphamide: 600mg per square meter every 3 weeks for four cycles / followed by docetaxel: 100 mg per square meter) every 3 weeks for four doses (AC-T)
breast cancer - adjuvant
open label
41 countries
P3 / DFS and OS compared between the 3 study group at 2-sided 5%, a step-down testing procedure has been proposed in order to compare the control arm (AC-T) to each trastuzumab-containing arm (AC-TH and TCH) at a level equal to alpha / 2 to account for multiple testing, if both of these comparisons reach statistical significance, then compare the two trastuzumab-containing arms at level alpha / 3IA: will be conducted after 300 (p=0.0002), 450 (p=0.0030) and 650 (p=0.0111) observed events. Final analysis at 900 (p=0.0461) events.
TCH improve significantly DFS compare to AC-T for women with HER2-positive BC, however results are exploratory for OS.
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