A Phase Ib/II, Multicenter, Study of the Combination of LEE011 and BYL719 with Letrozole in Adult Patients with Advanced ER+ Breast Cancer
The purpose of this trial is to inform the future clinical development of the two
investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha
This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate
the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and
BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole
(Arms 3 and 4).
The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further
characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the
combinations. Optional crossover for patients who have progressed while on dose escalation or
dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet
combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted
after protocol amendment 6.
Approximately 250 adult women with ER+/HER2- locally advanced or metastatic breast cancer
will be enrolled.
View more details from ClinicalTrials.gov.
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Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.