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MONALEESA-7: Phase III placebo-controlled study of
ribociclib and tamoxifen/NSAI + goserelin
Stratified by:
•
Presence/absence of liver/lung
metastases
•
Prior chemotherapy for advanced
disease
•
Endocrine therapy partner (tamoxifen
vs NSAI)
Primary endpoint
•
PFS (locally assessed per
RECIST v1.1)
‡
Secondary endpoints
•
Overall survival (key)
•
Overall response rate
•
Clinical benefit rate
•
Safety
•
Patient-reported
outcomes
•
Pre/perimenopausal
women with HR+,
HER2– ABC
•
No prior endocrine
therapy for advanced
disease
•
≤1 line of chemotherapy
for advanced disease
•
N=672
Randomization
(1:1)
Ribociclib
(600 mg/day; 3-weeks-on/1-
week-off)
+ tamoxifen/NSAI +
goserelin*
n=335
Placebo
+ tamoxifen/NSAI +
goserelin*
n=337
Tumor assessments were performed every 8 weeks for 18 months, then every 12 weeks thereafter
Primary analysis planned after ~329 PFS events
95% power to detect a 33% risk reduction (hazard ratio 0.67) with one-sided α=2.5%, corresponding to an increase in
median PFS to 13.4 months (median PFS of 9 months for the placebo arm
1,2
), and a sample size of 660 patients
NSAI, non-steroidal aromatase inhibitor; RECIST, Response Evaluation Criteria in Solid Tumors.
*Tamoxifen = 20 mg/day; NSAI: anastrozole = 1 mg/day or letrozole = 2.5 mg/day; goserelin = 3.6 mg every 28 days;
‡
PFS by Blinded Independent Review Committee conducted to support the primary endpoint.
1. Klijn JG,
et al
.
J Clin Oncol
2001;19:343–353; 2. Mourisden H,
et al
.
J Clin Oncol
2001;19:2596–2606.