ribociclib plus endocrine therapy (n=335) vs. endocrine therapy (n=337)
randomized controlled trial
ribociclib plus endocrine therapy plus goserelin
ribociclib: PO 600mg/day (3-weeks-on and 1-week-off) / endocrine therapy: tamoxifen (PO 20 mg) or anNSAI (letrozole 2.5 mg or anastrozole 1 mg) every day / goserelin: SC 3.6mg on day 1 of every cycle
placebo plus endocrine therapy plus goserelin
endocrine therapy: tamoxifen (PO 20 mg) or anNSAI (letrozole 2.5 mg or anastrozole 1 mg) every day / goserelin: SC 3.6mg on day 1 of every cycle
la/mBC - HR-positive - 2nd line (L2)
Exclusion criteria: patients who had received previous treatment with a CDK4/6 inhibitors, who had previous endocrine therapy in advanced setting, who had CNS metastases
double blind
188 centres in 30 countries
P3 / PFS at 1-sided at 2.5% (no IA), then if PFS is significant, testing of OS with 2 IA at 1-sided at 2.5%
PFS was significantly increased when ribociclib was added to endocrine therapy
MONALEESA-3, 2018 NCT02422615
ribociclib plus fulvestrant (n=484) vs. fulvestrant (n=242)
randomized controlled trial
ribociclib plus fulvestrant
ribociclib: PO 600mg per day, 3-weeks on and 1-week off / fulvestrant: IM 500mg on day 1 of each 28-day cycle with an additional dose on day 15 of cycle 1
placebo plus fulvestrant
fulvestrant: IM 500mg on day 1 of each 28-day cycle with an additional dose on day 15 of cycle 1
la/mBC - HR-positive - 2nd line (L2)
Exclusion criteria: previsous treatment with fulvestrant or CDK4/6 inhibitors
double blind
174 study sites in 30 countries
P3 / PFS at 1-sided at 0.025 (with no IA) / hierarchical testing strategy for OS at 1-sided at 0.025 (1st IA: 0.00013, 2nd IA: 0.01129, final analysis)