Reported safety, preliminary efficacy, and molecular analysis in ER+, HER2– BC from the
phase 1b dose escalation stage of the RIB plus ALP plus LET arm
ARM 1 (n ≈ 12-18):
RIB+LET
Phase 1b/2 Study
(N = 46)
• Postmenopausal women
with ER+, HER2− ABC
Primary endpoint
• MTD and/or RP2D
Secondary endpoints
• Safety, PK, and preliminary efficacy assessments
ABC, advanced breast cancer; ALP, alpelisib; ER+, estrogen receptor-positive; HER2–, human epidermal growth factor receptor-2–negative;
LET, letrozole; MTD, maximum tolerated dose; RIB, ribociclib; RP2D, recommended phase 2 dose
Juric D, et al. SABCS 2015; Abstract P3-14-01.
ARM 2 (n ≈ 12-18):
ALP+LET
ARM 3 (n ≈ 15-20):
RIB+ALP+LET
Define RP2Ds
ARM 1 (n ≈ 30):
RIB+LET
ARM 2 (n ≈ 45):
RIB+LET
Progressive
disease
ARM 3 (n ≈ 45):
RIB+ALP+LET
Optional
crossover
group
Define
RP2D
CLEE011X2107
Ribociclib in combination with alpelisib and letrozole in ER+,
HER2– BC
1
6
0
9
0
4
3
6
8
1
