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entinostat plus exemestane (n=305) vs. exemestane (n=303)
randomized controlled trial
entinostat plus exemestane
entinostat: PO 5mg one per week (28-day cycle) / exemestane: PO 25mg per day
placebo plus exemestane
exemestane: PO 25mg per day
la/mBC - HR-positive - 2nd line (L2)
double blind
from 111 centers in USA and South Africa
P3 / PFS and OS at 1-sided at 0.025 -> split: 0.001 for PFS (1 futility analysis) and 0.024 for OS (with 6 IA for OS with nominal significance 1: 0.00048 / 2: 0.00048 / 3: 0.00068 / 4: 0.004 / 5: 0.00805 / 6: 0.01193 and final 0.01872)
entinostat plus exemestane (n=64) vs. exemestane (n=66)
randomized controlled trial
entinostat plus exemestane
entinostat: PO 5mg once weekly / exemestane: PO 25mg daily
placebo plus exemestane
exemestane: PO 25mg daily
la/mBC - HR-positive - 2nd line (L2)
double blind
between June 2008 and July 2010
P2 / PFS at 1-sided at 0.1
It seems that entinostat can improve PFS in patients with ER-positive.
tucidinostat plus exemestane (n=244) vs. exemestane (n=121)
randomized controlled trial
tucidinostat plus exemestane
tucidinostat: PO 30mg twice a week for 4 consecutive weeks in a 4-week cycle / exemestane: PO 25mg/day
placebo plus exemestane
exemestane: PO 25mg/day
la/mBC - HR-positive - 2nd line (L2)
double blind
at 22 centres in China
P3 / PFS at 2-sided at 0.05
tucidinostat added to exemestane increased significantly PFS comaper to exemestane monotherapy. OS data were still immature
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