600- vs 400-mg First-Line Ribociclib in Hormone Receptor-Positive/ERBB2-Negative Advanced Breast Cancer: The AMALEE Randomized Clinical Trial.

ABSTRACT:

Importance

Ribociclib, 600 mg showed substantial survival benefits in patients with hormone receptor-positive (HR+)/ERRB2-negative (ERBB2-; formerly HER2) advanced breast cancer (ABC) in the phase 3 MONALEESA trials but was associated with dose-dependent adverse events (AEs) that were manageable with dose reductions.

Objective

To investigate whether a 400-mg ribociclib starting dose could reduce the incidence of AEs while maintaining efficacy in ABC.

Design, setting, and participants

The AMALEE phase 2, multicenter, randomized, open-label, interventional noninferiority study was conducted between June 18, 2019, and December 8, 2020, and included pre- and postmenopausal women with newly diagnosed HR+/ERBB2- ABC. The study was conducted across 107 sites in 23 countries

SUBMITTER: Cardoso F 

PROVIDER: S-EPMC12464849 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature