palbociclib plus letrozole (n=84) vs. letrozole (n=81)
randomized controlled trial
palbociclib plus letrozole
palbociclib: PO 125mg once daily for 3 weeks followed by 1 week off in 28-day cycles / letrozole: PO 2.5mg once daily
letrozole
letrozole: PO 2.5mg once daily
la/mBC - HR-positive - 1st line (L1)
open label
50 sites in 12 countries (Canada, Europe, South Africa, South Korea)
P2 / analysis of the primary endpoint was initially intendedto be based on cohort 2 only, but an unplanned interim analysis was done in cohort 1 and amended (prospectively) the statistical analysis plan such that the primary endpoint would be analysed in cohorts 1 and 2 combined instead of cohort 2 alone/ PFS at 1-sided at 0.1
PALOMA-2, 2016 NCT01740427
palbociclib plus letrozole (n=444) vs. letrozole (n=222)
randomized controlled trial
palbociclib plus letrozole
palbociclib : PO 125mg per day, in 4-weeks cycle (3-weeks on and 1-week off) / letrozole: PO 2.5mg per day
placebo plus letrozole
letrozole: PO 2.5mg per day
la/mBC - HR-positive - 1st line (L1)
double blind
186 sites in 17 countries
P3 / PFS will be tested at 1-sided at 0.025 (with 1 IA at 0.000013, and 0.025 at the final analysis) / hierarchically test for OS