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细胞增殖、生长和分裂等过程受到细胞周期的严格调控，其调控机制在肿瘤的发生发展中发挥重要作用。近年来，多项研究显示，细胞周期蛋白依赖性激酶4和6（ CDK4／6）抑制剂对于雌激素受体阳性或人类表皮生长因子受体阳性的乳腺癌患者具有较好的疗效，然而其在三阴性乳腺癌患者中的作用仍存在争议，故探究相关分子标志物以进一步筛选最能从该治疗中获益的乳腺癌人群对临床具有重要意义。此外视网膜母细胞瘤基因（ Rb）也在乳腺癌中扮演关键角色，而cyclin D?CDK4／6?Rb信号通路因具有调控细胞周期限制点的作用，被认为是乳腺癌潜在的治疗靶点。本文将对CDK4／6抑制剂在乳腺癌治疗中的研究进展作一综述。“,”Cellular proliferation, growth, and division are tightly controlled by the cell?cycle regulatory machinery. Recently, cyclin?dependent kinase 4 and 6( CDK4/6) inhibitors were identified to be useful in breast cancer patients with positive estrogen recep?tor or amplified HER?2, whereas the role remains controversial in triple?negative breast cancer. It is of great importance to investigate the predictive biomarkers for identifying which subgroup of breast cancer patients would mostly benefit from such treatment. Moreover, tumor suppressor retinoblastoma( Rb) plays a pivotal importance in breast cancer, and cyclin D?CDK4/6?Rb pathway, governing the cell cycle restriction point in breast cancer, is a potential target for anticancer therapy. In this article, we review the preclinical and clinical data and describe the future development on the role of CDK4/6 inhibitors in breast cancer.