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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 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)
la/mBC - HR-positive - 1st line (L1)
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
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