Considerations for emulations of randomized controlled trials using real-world data: learnings from an emulation of MONALEESA-2.

ABSTRACT: Aim: The eligibility criteria of randomized controlled trials can exclude groups of patients indicated for the therapy post-approval and the trial population may not be generalizable to routine care. We attempted to emulate the MONALEESA-2 trial of ribociclib plus letrozole for women with advanced breast cancer using real-world data (RWD) to assess the impact of modifying entry criteria of the trial, which found a survival benefit associated with ribociclib (hazard ratio [HR] = 0.76). Materials & methods: Post-menopausal women with recurrent or metastatic breast cancer were identified in a linked electronic health records-claims database. Treatment groups were ribociclib plus letrozole or letrozole without ribociclib (referred to as letrozole). Overall survival was compared b

SUBMITTER: Kong AM 

PROVIDER: S-EPMC12580918 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature