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CDK4/6抑制剂为激素受体(HR)阳性人表皮生长因子受体2(HER-2)阴性乳腺癌患者的临床管理模式带来革新。全球上市的CDK4/6抑制剂包括哌柏西利、Ribociclib和阿贝西利。对于HR阳性HER-2阴性局部晚期和转移性乳腺癌，CDK4/6抑制剂联合芳香化酶抑制剂或氟维司群一线或二线及以上治疗均可大幅度降低疾病进展或死亡风险，不良反应可控。鉴于CDK4/6抑制剂联合内分泌治疗在中国的临床应用刚开始起步，国家肿瘤质控中心乳腺癌专家委员会和中国抗癌协会肿瘤药物临床研究专业委员会组织相关领域专家，制定了CDK4/6抑制剂临床应用专家共识，系统性介绍CDK4/6抑制剂的药理学特征、用药监测以及不良事件管理等，以期加深临床肿瘤医师对CDK4/6抑制剂药物的认知，推进临床决策的精准性，达到延长患者生存时间和提高生活质量的最终目标。“,”The introduction of cyclin-dependent kinase (CDK) 4/6 inhibitors has revolutionized the clinical management paradigm of hormone receptor (HR) positive/human epidermal growth factor receptor (HER) 2 negative breast cancer. As of today, CDK 4/6 inhibitors including Palbociclib, Ribociclib, and Abemaciclib have been widely approved by regulatory agencies. Randomized clinical trials demonstrated that CDK 4/6 inhibitors in combination with an aromatase inhibitor (AI) or fulvestrant in the first-, second- or later-line setting for HR positive/HER2 negative locally advanced or metastatic breast cancer led to substantial reduction in the risk of disease progression or death. Adverse effects of treatment were manageable and as or better than expected in terms of patient satisfaction. Considering CDK4/6 inhibitors in combination with endocrine therapy being a novel approach in China clinical practice, the panel developed the consensus comprehensively describing the pharmacology properties, monitoring strategy during treatment and adverse events management, to facilitate greater understanding in Chinese oncologists of a whole new therapeutic class of drug, promote accuracy of clinical decision and help reach the ultimate goal of improving survival and quality of life of the target patient population.