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abemaciclib plus fulvestrant (n=446) vs. fulvestrant (n=223)
randomized controlled trial
abemaciclib plus fulvestrant
abemaciclib: 150mg twice per day, during each 28-days cycle (after amendment for reducing 200mg twice a day) / fulvestrant: IM 500mg on days 1 and 15 of the first cycle, and then the first day of each cycle
placebo plus fulvestrant
fulvestrant: IM 500mg on days 1 and 15 of the first cycle, and then the first day of each cycle
la/mBC - HR-positive - 2nd line (L2)
double blind
P3 / hierarchical testing approach, with first PFS at 1-sided at 0.025, with 1 IA (with alpha at 0.00001) and final analysis at alpha at 0.02499996, and then OS, with 3 IA.
dalpiciclib plus fulvestrant (n=241) vs. fulvestrant (n=120)
randomized controlled trial
dalpiciclib plus fulvetrant
dalpiciclib: PO 150mg/day for 3-weeks on and 1-week off in each 4-cycle / fulvestrant: IM 500mg on day 1 and 15 of the first cycle and on day 1 of each subsequent 4-week cycle.
placebo (matching dulpaciclib) plus fulvestrant
fulvestrant: IM 500mg on day 1 and 15 of the first cycle and on day 1 of each subsequent 4-week cycle.
la/mBC - HR-positive - 2nd line (L2)
double blind
39 centers in China
P3 / 1-sided at 0.025 for PFS with 1IA (α = 0.0074 ) and final analysis (α = 0.0227)
dalpiciclib added to fuvestrant improved significantly PFS compate to fulvestrant alone, in patients with HR-positive, and HER2-negaive BC.
palbociclib plus fulvestrant (n=347) vs. fulvestrant (n=174)
randomized controlled trial
palbociclib plus fulvestrant
palbociclib: PO 125mg/day 3weeks in/1week off / fulvestrant: IM 500mg
placebo plus fulvestrant
fulvestrant: IM 500mg
Premenopausal or perimenopausal patients received goserelin for the duration of study treatment, starting at least 4 weeks before randomization and continuing every 28 days.
la/mBC - HR-positive - 2nd line (L2)
double blind
144 centers in 17 countries (Asia, Australia, Europe, North America)
P3 / PFS at 1-sided at 0.025 with 1 IA (at 0.00135) / hierarchical test for OS with 2IA
palbociclib plus fulvestrant (n=94) vs. fulvestrant (n=95)
randomized controlled trial
palbociclib plus fulvestrant
palbociclib: 125 mg/day, 28-day cycles; 3 weeks on, 1 week off / fulvestrant: 500 mg on days 1, 14, 28, and every 28 days onward
placebo plus fulvestrant
fulvestrant: 500 mg on days 1, 14, 28, and every 28 days onward
la/mBC - HR-positive - 2nd line (L2)
double blind
32 institutions in 2 countries
P2 / PFS at 2-sided at 0.02 / no IA
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
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)
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