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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.
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