palbociclib (n=2884) vs. endocrine therapy (n=2877)
randomized controlled trial
breast cancer - adjuvant
open label
406 centers in 21 countries (worldwide)
P3 / IDFS at 1-sided at 0.025, wit 2 IA (1st: 0.0001, 2nd: 0.0060, final 0.0231) / All statistical inferences for secondary efficacy and patient safety will use two-sidedalpha = 0.05 without adjustment for multiplicity and without applying a sequentialtesting procedure