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FLIPPER, 2021 NCT02690480

palbociclib plus fulvestrant (n=94) vs. fulvestrant (n=95)

randomized controlled trial

Studied treatment

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

Control treatment

placebo plus fulvestrant
fulvestrant: 500 mg on days 1, 14, 28, and every 28 days onward

Patients

la/mBC - HR-positive - 2nd line (L2)

Method

double blind

32 institutions in 2 countries

P2 / PFS at 2-sided at 0.02 / no IA

Remark

PALOMA-3, 2016 NCT01942135

palbociclib plus fulvestrant (n=347) vs. fulvestrant (n=174)

randomized controlled trial

Studied treatment

palbociclib plus fulvestrant
palbociclib: PO 125mg/day 3weeks in/1week off / fulvestrant: IM 500mg

Control treatment

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.

Patients

la/mBC - HR-positive - 2nd line (L2)

Method

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

Remark