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tucatinib plus trastuzumab plus capecitabine (n=410) vs. trastuzumab plus capecitabine (n=202)
randomized controlled trial
tucatinib plus trastuzumab plus capecitabine
tucatinib: 300mg PO twice daily / trastuzumab: 6 mg IV per kg of body weight once every 21 days, with an initial loading dose of 8 mg per kg; subcutaneous administration was allowed / capecitabine: 1000 mg PO per square meter of body-surface area orally twice daily on days 1 to 14 of each 21-day cycle
placebo plus trastuzumab plus capecitabine
placebo: PO twice daily / trastuzumab: 6 mg IV per kg of body weight once every 21 days, with an initial loading dose of 8 mg per kg; subcutaneous administration was allowed / capecitabine: 1000 mg PO per square meter of body-surface area orally twice daily on days 1 to 14 of each 21-day cycle
la/mBC - HER2 positive - 2nd Line (L2)
Excludion criteria: had previously received treatment for metastatic disease with capecitabine or a HER2-targeted tyrosine kinase inhibitor (although patients who had received lapatinib more than 12 months before initiating a trial regimen), patients with leptomeningeal disease
double-blind
155 sites in 15 countries
P2 / To maintain strong control of the family-wise type I error rate at 0.05, the PFS in the ITT population will be tested at 0.05, if it is significant, te alpha will be split between OS (0.02) and the PFS (in patients with brain metastases) (0.03) (If only one of OS and PFS(with brain metastases) is statistical significant, the unused alpha can be passed to the other one following the GSHv procedure.) / 1 IA for PFS (with brain metastases) with alpha at 0.008, and 2 IA for OS (1st IA alpha at 0.007) / (ITT population was not the same for PFS and OS, because authors continued to include patients to increase the power for the analyses)
The study met its primary endpoints. Adding tucatinib to trastzumab and capecitabine incrase significantly the PFS and OS.
tucatinib plus trastuzumab plus capecitabine (n=198) vs. trastuzumab plus capecitabine (n=93)
randomized controlled trial
tucatinib plus trastuzumab plus capecitabine
tucatinib: 300mg PO twice daily / trastuzumab: 6 mg IV per kg of body weight once every 21 days, with an initial loading dose of 8 mg per kg; subcutaneous administration was allowed / capecitabine: 1000 mg PO per square meter of body-surface area orally twice daily on days 1 to 14 of each 21-day cycle
placebo plus trastuzumab plus capecitabine
placebo: PO twice daily / trastuzumab: 6 mg IV per kg of body weight once every 21 days, with an initial loading dose of 8 mg per kg; subcutaneous administration was allowed / capecitabine: 1000 mg PO per square meter of body-surface area orally twice daily on days 1 to 14 of each 21-day cycle
la/mBC - HER2 positive - 2nd Line (L2)
Excludion criteria: had previously received treatment for metastatic disease with capecitabine or a HER2-targeted tyrosine kinase inhibitor (although patients who had received lapatinib more than 12 months before initiating a trial regimen), patients with leptomeningeal disease
double-blind
155 sites in 15 countries
P2 / To maintain strong control of the family-wise type I error rate at 0.05, the PFS in the ITT population will be tested at 0.05, if it is significant, te alpha will be split between OS (0.02) and the PFS (in patients with brain metastases) (0.03) (If only one of OS and PFS(with brain metastases) is statistical significant, the unused alpha can be passed to the other one following the GSHv procedure.) / 1 IA for PFS (with brain metastases) with alpha at 0.008, and 2 IA for OS (1st IA alpha at 0.007) / (ITT population was not the same for PFS and OS, because authors continued to include patients to increase the power for the analyses)
Adding tucatinib to trastuzumab and capecitabine increase significantly PFS for patients with brain metastases.
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