Table 2.

Palbociclib phase III breast cancer studies

Clinicaltrials.gov identifier/study nameDesignArmsSettingPrimary endpoint
NCT01740427Randomized 2:1, double-blindPAL + letrozole vs. placebo + letrozoleER+, HER2, ABC, first-linePFS
PALOMA-2N = 666
NCT01942135Randomized 2:1, double-blindPAL + fulvestrant vs. placebo +ER+, HER2, MBC, progression afterPFS
PALOMA-3N = 521fulvestrantprior hormonal therapies
NCT02297438Randomized 1:1, double-blindPAL+ letrozole vs. placebo + letrozoleER+, HER2, ABC, first-linePFS
PALOMA-4N = 330 (target)Asian regional postmenopausal
NCT02028507Randomized 1:1, open-labelPAL+ exemestane vs. capecitabineER+, HER2, MBC resistant toPFS
PEARLN = 348 (target)nonsteroidal aromatase inhibitors
NCT01864746Randomized 1:1, double-blindPAL + standard endocrine therapy vs.HR+, HER2, high risk, adjuvantiDFS
PENELOPE-BN = 800 (target)placebo + standard endocrine therapy
PlannedRandomized 1:1, open-labelPAL + standard endocrine therapy vs.HR+, HER2, adjuvantiDFS
PALLASN = 4,600 (target)standard endocrine therapy

Abbreviations: ABC, advanced breast cancer; HR, hormone receptor; iDFS, invasive disease-free survival; PAL, palbociclib.