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First-line CDK inhibitors Study Designs

HR+, HER2- ABC

Postmenopausal

Noprior systemic therapy in

this setting

If neoadjuvant or adjuvant ET

administered, a disease free

interval of >12 months since

completion of ET

ECOG PS ≤1

abemaciclib: 150 mg

BID

Abemaciclib

plus

AI

Randomization

2 :1

placebo

plus

AI

N=493

abemaciclib: 150 mg

BID

Palbociclib

plus

AI

Randomization

2 :1

placebo

plus

AI

N=666

abemaciclib: 150 mg

BID

Ribociclib

plus

AI

Randomization

1 :1

placebo

plus

AI

N=668

PALOMA-2

1

MONALEESA-2

2

MONARCH-3

3

Primary endpoint:

Investigator-assessed PFS

1

Finn RS, et al. N Engl J Med 2016;

2

Hortobagyi G, et al. N Engl J Med 2016;

3

di Leo A, et al. J Clin Oncol 2017