Article(id=1291404667418825294, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404554201985968, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.06.026, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1729353600000, receivedDateStr=2024-10-20, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824465851, onlineDateStr=2026-08-04, pubDate=1743091200000, pubDateStr=2025-03-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824465851, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824465851, creator=13701087609, updateTime=1785824465851, updator=13701087609, issue=Issue{id=1291404554201985968, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='6', pageStart='751', pageEnd='900', issueExtLink='null', onlineDate='null', pubDate='1743091200000', pubDateStr='2025-03-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824438858, creator='13701087609', updateTime=1785824438858, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=886, endPage=889, ext={EN=ArticleExt(id=1291404667917947473, articleId=1291404667418825294, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=New AKT inhibitor for the treatment of breast cancer——Capivasertib, columnId=1291339032068354347, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=New Drugs Introduction, runingTitle=null, highlight=null, articleAbstract=

Endocrine therapy is the main treatment mode for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer, but primary or secondary endocrine resistance can lead to treatment failure and affect patient survival. Studies have shown that abnormalities in the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR) pathway (PAM pathway) account for more than 50% of endocrine-resistant patients. The PAM pathway is not only the main mechanism of endocrine therapy resistance in breast cancer, but also mediates resistance to chemotherapy and targeted therapy. AKT is one of the core kinases of the PAM pathway, and inhibiting its activity can inhibit the aberrant activation of the pathway. Capivasertib is the first AKT kinase inhibitor, and in the phase Ⅲ CAPItello-291 clinical study, compared with fulvestrant alone, the combination of capivasertib and fulvestrant significantly increased PFS in the overall population and the phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha/protein kinase B/phosphatase and tensin homolog (PIK3CA/AKT/PTEN)mutant population. In addition, capivasertib has a good safety profile, and the common adverse reactions are elevated blood glucose, diarrhea, and skin adverse reactions, which are mostly grade 1-2 and can be well tolerated. Breast cancer treatment guidelines all recommend it for post-line selection in people with PIK3CA/AKT/PTEN mutations who have failed endocrine therapy. This article mainly introduces the pharmacological mechanism, pharmacodynamics, pharmacokinetics, clinical trials and safety information of capivasertib, in order to facilitate the clinical application of the drug.

, authors=Rui SHI, Yan-hua ZHANG, authorsList=Rui SHI, Yan-hua ZHANG, authorCompany=null, correspAuthors=Yan-hua ZHANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404668651950675, articleId=1291404667418825294, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=乳腺癌治疗新药AKT抑制药——Capivasertib, columnId=1291339032219349293, journalTitle=中国临床药理学杂志, columnName=新药介绍, runingTitle=null, highlight=null, articleAbstract=

内分泌治疗是激素受体阳性/表皮生长因子受体2阴性（HR+/HER2-）晚期乳腺癌患者的主要治疗模式，但原发性或继发性耐药可导致治疗失败，影响患者生存。研究显示，磷脂酰肌醇3-激酶（PI3K）-蛋白激酶B（AKT）-哺乳动物雷帕霉素靶蛋白（mTOR）通路（PAM通路）异常占耐药患者的50%以上。PAM通路不仅是乳腺癌内分泌治疗耐药的主要机制，同时也介导化疗、靶向治疗耐药。AKT是PAM通路的核心激酶之一，抑制其活性可抑制PAM通路的异常激活。Capivasertib是首个AKT激酶抑制药，在Ⅲ期CAPItello-291临床研究中，capivasertib与氟维司群联合组与氟维司群单药组相比，总体人群、磷脂酰肌醇-3-激酶催化亚基α/蛋白激酶B/磷酸酶和张力同源蛋白（PIK3CA/AKT/PTEN）突变人群PFS均显著延长。此外，capivasertib安全性良好，常见药物不良反应为血糖升高、腹泻及皮肤药物不良反应，多为1~2级，可耐受。国内外指南均推荐其可用于内分泌治疗失败具有PIK3CA/AKT/PTEN突变人群的后线选择。本文主要介绍capivasertib的药理机制、药效学、药代动力学、临床试验和安全性信息等内容，以期助于该药物的临床应用。

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史蕤（1987-），女，主管药师，主要从事肿瘤临床药学方面工作

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史蕤（1987-），女，主管药师，主要从事肿瘤临床药学方面工作

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