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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.
doxorubicin plus cyclophosphamide followed by docetaxel plus trastuzumab (n=1074) vs. docetaxel plus carboplatin with trastuzumab followed by trastuzumab (n=1075)
randomized controlled trial
doxorubicin plus cyclophosphamide followed by docetaxel plus trastuzumab
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 / plus AC-T
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
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.
No significant difference in the rateof disease-free or overall survival was seen between the two trastuzumab-containing regimens, however results were not reported.
doxorubicin plus cyclophosphamide followed by docetaxel plus trastuzumab (n=1074) vs. doxorubicin plus cyclophosphamide followed by docetaxel (n=1073)
randomized controlled trial
doxorubicin plus cyclophosphamide followed by docetaxel plus trastuzumab
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 / plus AC-T
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.
Addition of trastuzumab significantly improve DFS for women with HER2-positive BC, however results are exploratory for OS.
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
trastuzumab plus endocrine therapy (n=196) vs. trastuzumab plus chemotherapy (n=196)
randomized controlled trial
trastuzumab plus endocrine therapy
trastuzumab: on day 1 of study treatment as an initial loading dose of 8 mg/kg. Subsequent dosing and scheduling of trastuzumab was 6 mg/kg every 3 weeks / endocrine therapy
trastuzumab plus chemotherapy
trastuzumab: on day 1 of study treatment as an initial loading dose of 8 mg/kg. Subsequent dosing and scheduling of trastuzumab was 6 mg/kg every 3 weeks / chemotherapy
la/mBC - HER2 positive - 1st Line (L1)
open label
in 9 hospitals in China
P3 / nononferiority, PFS at 0.025 and HR <1.35 / All efficacy analysis will be performed based on the ITT population
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