Document Type
Article
Publication Date
12-1-2025
Abstract
Purpose of Review: To discuss the biological mechanisms of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, the rationale for using CDK4/6 inhibitors in estrogen receptor-positive (ER+) and human epidermal growth factor receptor-2-negative (HER2-) breast cancer (BC), data from landmark phase III clinical trials that led to U.S. Food and Drug Administration (FDA) approval, and updates on recently published and ongoing clinical trials. Finally, we explore future directions of CDK4/6 inhibitors in the management of ER+ and HER2- BC. Recent Findings: Based on landmark phase III clinical trials, CDK4/6 inhibitors have become essential to treat ER+ and HER2- BC. Summary: New therapeutic strategies focused on CDK4/6 inhibitors are being evaluated and are expected to enter future pre-clinical and clinical trials, expanding the use of CDK4/6 inhibitors beyond currently FDA-approved indications.
Keywords
breast cancer, CDK4/6 inhibitor, clinical trials, cyclin-dependent kinase, endocrine therapy resistance
Language
English
Publication Title
Current Breast Cancer Reports
Rights
© 2025, The Author(s). This is an Open Access work distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.
Recommended Citation
Mizukami, T., Montero, A.J. Progress in Clinical Trials of CDK4/6 Inhibitors. Curr Breast Cancer Rep 17, 41 (2025). https://doi.org/10.1007/s12609-025-00606-0
Manuscript Version
Final Publisher Version