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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
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
palbociclib plus endocrine therapy (n=92) vs. capecitabine (n=86)
randomized controlled trial
palbociclib plus exemestane
palbociclib: PO 125mg/day for 3weeks / exemestane: 25mg/day for 4weeks / leuprolide: SC 3.75mg
capecitabine
capecitabine: 1250 mg/m² twice a day for 2 weeks, repeated every 3 weeks
la/mBC - HR positive
open label
14 sites in South Korea
P2 / PFS at 1-sided at 0.05 with 1 IA : IA at 0.0055 (-sided) and final analysis at 0.0485 ->However, the plan had to be changed to no interim analysis because of the high accrual rate on Sept 27, 2018
Exploratory results: it seems that palbociclib plus endocrine therapy increase PFS in premenopausal women with HR-positive metstatic breast cancer
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
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
palbociclib plus fulvestrant (n=347) vs. fulvestrant (n=174)
randomized controlled trial
palbociclib plus fulvestrant
palbociclib: PO 125mg/day 3weeks in/1week off / fulvestrant: IM 500mg
placebo plus fulvestrant
fulvestrant: IM 500mg
Premenopausal or perimenopausal patients received goserelin for the duration of study treatment, starting at least 4 weeks before randomization and continuing every 28 days.
la/mBC - HR-positive - 2nd line (L2)
double blind
144 centers in 17 countries (Asia, Australia, Europe, North America)
P3 / PFS at 1-sided at 0.025 with 1 IA (at 0.00135) / hierarchical test for OS with 2IA
palbociclib plus fulvestrant (n=94) vs. fulvestrant (n=95)
randomized controlled trial
palbociclib plus fulvestrant
palbociclib: 125 mg/day, 28-day cycles; 3 weeks on, 1 week off / fulvestrant: 500 mg on days 1, 14, 28, and every 28 days onward
placebo plus fulvestrant
fulvestrant: 500 mg on days 1, 14, 28, and every 28 days onward
la/mBC - HR-positive - 2nd line (L2)
double blind
32 institutions in 2 countries
P2 / PFS at 2-sided at 0.02 / no IA
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