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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.
neratinib plus capecitabine (n=51) vs. lapatinib plus capecitabine (n=50)
randomized controlled trial
neratinib plus capecitabine
neratinib: 240 mg PO once daily continuously in 21-day cycles with no break between cycles / capecitabine: 1,500 mg/m2 PO daily in 2 evenly spaced doses [750 mg/m2 twice a day] on days 1-14 of 21-day cycles ///// Prophylactic antidiarrheal medication was mandated for the duration of cycle 1 in this group
lapatinib plus capecitabine
lapatinib: 1,250 mg PO once daily continuously / capecitabine: 2,000 mg/m2 PO daily in 2 evenly spaced doses [1,000 mg/m2 twice a day] on days 1-14 of 21-day cycles
la/mBC - HER2 positive - 2nd Line (L2)
open-label
203 sites in 28 countries in Europe, North and South America, Asia, and Australia
P3 / Coprimary end points were analyzed using an overall type I error rate of 0.01 for PFS and 0.04 for OS. No interim analysis. (trial was considered positive if either PFS or OS were statistically significant at the split alpha level).Descriptive analysis for this study population (patients with brain metastasis)
Descriptive analysis for this population (patients with brain metastasis)
neratinib plus capecitabine (n=307) vs. lapatinib plus capecitabine (n=314)
randomized controlled trial
neratinib plus capecitabine
neratinib: 240 mg PO once daily continuously in 21-day cycles with no break between cycles / capecitabine: 1,500 mg/m2 PO daily in 2 evenly spaced doses [750 mg/m2 twice a day] on days 1-14 of 21-day cycles ///// Prophylactic antidiarrheal medication was mandated for the duration of cycle 1 in this group
lapatinib plus capecitabine
lapatinib: 1,250 mg PO once daily continuously / capecitabine: 2,000 mg/m2 PO daily in 2 evenly spaced doses [1,000 mg/m2 twice a day] on days 1-14 of 21-day cycles
la/mBC - HER2 positive - 2nd Line (L2)
open-label
203 sites in 28 countries in Europe, North and South America, Asia, and Australia
P3 / Coprimary end points were analyzed using an overall type I error rate of 0.01 for PFS and 0.04 for OS. No interim analysis. (trial was considered positive if either PFS or OS were statistically significant at the split alpha level)
Neratinib plus capecitabine significantly improved PFS but not significantly for OS, compared to lapatinib plus capecitabine.
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