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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.
neratinib (n=1420) vs. placebo (n=1420)
randomized controlled trial
neratinib
neratinib: 240mg PO daily for 12 months
placebo
placebo: PO daily for 12 months
breast cancer - adjuvant
double blind
495 centers in Europe, Asia, Australia, New Zealand, and North and South America
P3 / IDFS in ITT population at 2-sided 5%. no IA planned. There were 3 different sponsors during the study, resulting to 3 global amendments with notable changes to study design. Final amendment: IDFS in the ITT population at 2yr.
pertuzumab plus trastuzumab (n=2400) vs. trastuzumab (n=2404)
randomized controlled trial
pertuzumab plus trastuzumab plus chemotherapy
pertuzumab: 840 mg IV as a loading dose, followed by 420 mg IV every 3 weeks / trastuzumab: 8mg per kg of body weight IV as a loading dose, followed by 6 mg per kg IV every 3 weeks / --> both beginning at the first cycle of taxane therapy and continuing for a maximum of 18 cycles within 1 year
placebo plus trastuzumab plus chemotherapy
placebo / trastuzumab: 8mg per kg of body weight IV as a loading dose, followed by 6 mg per kg IV every 3 weeks / --> both beginning at the first cycle of taxane therapy and continuing for a maximum of 18 cycles within 1 year
chemotherapy: Anti-HER2 treatment was given in combination with chemotherapy according to one of the following schedules: 3 or 4 cycles (every 3 weeks) of 5-fluorouracil plus either epirubicin or doxorubicin plus cyclophosphamide, followed by 3 or 4 cycles (every 3 weeks) of docetaxel or 12 weekly cycles of paclitaxel; 4 cycles (every 3 weeks or every 2 weeks) of cyclophosphamide plus either doxorubicin or epirubicin, followed by either 4 cycles (every 3 weeks) of docetaxel or 12 weekly cycles of paclitaxel; or 6 cycles (every 3 weeks) of docetaxel plus carboplatin
breast cancer - adjuvant
Exclusion criteria: Patients with previous invasive breast cancer, nonbreast cancer within 5 years before randomization, any previous chemotherapy or radiotherapy for cancer, any previous anti-HER2 therapy or other previous anticancer biologic therapy or immunotherapy
double blind
549 centers across 43 countries
P3 / controlled at 5% 2-sided, use of a hierarchical testing procedure: if IDFS is significant, following endpoints will be tested in the following order: IDFS including second primary non-breast cancer, DFS, OS. For OS, 3 IA: 1st at IDFS final p<0.00001, 2nd at 4-5 yr after last randomization: p=0.0027, 3rd at 7-8 yr after last randomization p=0.0139, final at 640 OS events (9-10yr) p = 0.0453
IDFS and DFS were significantly higher in the pertuzumab group compare to the placebo group.
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