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New targeted therapies have been developed to overcome resistance to endocrine therapy (ET) and improve the outcome of HR+/HER2-advanced breast cancer (ABC).We conducted a meta-analysis and systemic review on randomized controlled trials evaluating various targeted therapies in combination with ET in HR+/ HER2-ABC.PUBMED and EMBASE databases were searched for eligible trials.Hazard ratios (HRs) for progression-free survival (PFS),odds ratios (ORs) for objective response rate (ORR),clinical benefit rate (CBR),and toxicity were meta-analyzed.Twenty-six studies with data on 10 347 patients were included and pooled.The addition of cyclin-dependent kinase 4/6 inhibitors to ET significantly improved median PFS (pooled HR =0.547,P ＜ 0.001),overall survival (pooled HR =0.755,P ＜ 0.001),and tumor response rates (ORR,pooled OR =1.478,P ＜ 0.001;CBR,pooled OR =1.201,P ＜ 0.001) with manageable toxicities (pooled OR =3.280,P ＜ 0.001).The mammalian targets of rapamycin inhibitors and exemestane were not clinically beneficial for this pooled population including ET-na(i)ve and ET-resistant patients.Moderate improvement in PFS (pooled HR =0.686,P ＜ 0.001) yet pronounced toxicities (pooled OR=2.154,P ＜ 0.001) were noted in the combination of phosphatidylinositol-4,5-bisphosphate 3-kinase inhibitors with fulvestrant.Future studies are warranted to optimize the population and the dosing sequence of these available options.