Phase Ib Dose-escalation/Expansion Trial of Ribociclib in Combination With Everolimus and Exemestane in Postmenopausal Women with HR⁺, HER2^- Advanced Breast Cancer.

ABSTRACT:

Purpose

Report results of the phase Ib dose-escalation/expansion study of triplet therapy with cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor (ribociclib), mTOR inhibitor (everolimus), and endocrine therapy (exemestane).

Patients and methods

Postmenopausal women with hormone receptor-positive (HR⁺), human epidermal growth factor receptor 2-negative (HER2^-), pretreated, advanced breast cancer (ABC) were enrolled. The primary objective of the dose-escalation phase was to estimate the MTD and recommended phase II dose (RP2D) of triplet therapy through evaluation of the incidence of dose-limiting toxicities. Safety, tolerability, and efficacy of the RP2D were evaluated in the dose-expansion phase in patients naïve or refractory to CDK4/6 inhibitor ther

SUBMITTER: Bardia A 

PROVIDER: S-EPMC8489181 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature