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
PENELOPE-B, 2021 NCT01864746
palbociclib plus endocrine therapy (n=628) vs. endocrine therapy (n=616)
randomized controlled trial
palbociclib plus endocrine therapy according to local standars (physician's choice)
palbociclib: PO 125mg/day for 21 days
placebo plus endocrine therapy according to local standars (physician's choice)
breast cancer - adjuvant
double blind
221 sites and 11 countries (Australia, Asia, Europe, USA
P3 / IDFS at 5% with 2 IA for efficacy -> 1st <0.0002, 2nd <0.0120 and final analysis <0.0463 / adjustment for multiple testing in other tests was not planned
Palbociclid did not improve IDFS compare to placebo for patients with HR-positive / HER2-negative breast cancer