Phase I/II Trial of Exemestane, Ribociclib, and Everolimus in Women with HR⁺/HER2^- Advanced Breast Cancer after Progression on CDK4/6 Inhibitors (TRINITI-1).

ABSTRACT:

Purpose

Standard-of-care treatment for metastatic hormone receptor-positive (HR⁺), HER2-negative (HER2^-) breast cancer includes endocrine therapy (ET) combined with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i). Optimal treatment after progression on CDK4/6i is unknown. The TRINITI-1 trial investigated ribociclib, a CDK4/6i that has recently demonstrated significant overall survival benefit in two phase III trials, in combination with everolimus and exemestane in patients with HR⁺, HER2^- advanced breast cancer (ABC) after progression on a CDK4/6i.

Patients and methods

This multicenter, open-label, single-arm, phase I/II study included patients with locally advanced/metastatic HR⁺/HER2^- breast cancer. The p

SUBMITTER: Bardia A 

PROVIDER: S-EPMC8487593 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature