600- vs 400-mg First-Line Ribociclib in Hormone Receptor–Positive/-Negative Advanced Breast Cancer

Does ribociclib, 400 mg, preserve efficacy with reduced toxic effects vs ribociclib, 600 mg, in hormone receptor–positive (HR)/–negative () advanced breast cancer?In the final analysis of this phase 2 randomized clinical trial of 376 women with HR/ advanced breast cancer, ribociclib, 400 mg, did not meet noninferiority criteria vs ribociclib, 600 mg, for overall response rate (48.9% vs 56.1%). The response duration and progression-free survival were similar, while Fridericia-corrected QT interval prolongation and neutropenia rates were lower with ribociclib, 400 mg.The trial results suggest that the ribociclib starting dose for HR/ advanced breast cancer should remain 600 mg, but dose reduction can help manage certain adverse events.

Corresponding Author: Fatima Cardoso, MD, Medical Oncology, ABC Global Alliance, Lisbon, Portugal (fcardoso@abcglobalalliance.org).

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