{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T07:01:52Z","timestamp":1792047712748,"version":"4.4.0"},"reference-count":33,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2024,4,2]],"date-time":"2024-04-02T00:00:00Z","timestamp":1712016000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To review the pharmacology, efficacy, and safety of capivasertib for the treatment of adults with hormone receptor-positive, HER2-negative (HR+\/HER2\u2013) locally advanced or metastatic breast cancer with 1 or more PIK3CA\/AKT1\/PTEN alterations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data sources:<\/jats:title>\n                    <jats:p>A literature search was conducted using PubMed and MEDLINE databases, published abstracts, and studies from ClinicalTrials.gov between 2003 and February 2024. Keywords included capivasertib, AZD5363, PI3K\/AKT\/mTOR pathway, and breast cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data extraction:<\/jats:title>\n                    <jats:p>All applicable publications, package inserts, meeting abstracts, and clinical trials with capivasertib were reviewed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data synthesis:<\/jats:title>\n                    <jats:p>Capivasertib is a first-in-class inhibitor of 3 isoforms of AKT (AKT-1, AKT-2, and AKT-3) which is an essential component in the PI3K\/AKT\/mTOR signaling pathway involved in oncogenesis. In the phase III CAPItello-291 trial, capivasertib in combination with fulvestrant (C+F) demonstrated improved progression-free survival (PFS) (7.3 vs 3.1 months) compared with placebo-fulvestrant (P+F) cohort in AKT-altered pathway patients who had progressed through prior aromatase inhibitor. The most common adverse reactions of any grade reported in the C+F group were diarrhea, cutaneous skin reactions, nausea, fatigue, and vomiting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to patient care and clinical practice in comparison with existing drugs:<\/jats:title>\n                    <jats:p>HR+\/HER2\u2013 advanced breast cancer patients experience progression following endocrine therapies and cyclin-dependent kinase (CDK) 4\/6 inhibitors. Capivasertib is a viable treatment option for patients with PIK3CA\/AKT1\/PTEN activating mutations following progression on endocrine-based regimens in the metastatic setting or recurrence within 12 months of completing adjuvant therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Integration of capivasertib into clinical practice is ongoing; intermittent dosing and favorable toxicity are attractive for future novel combination prospective trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280241241531","type":"journal-article","created":{"date-parts":[[2024,4,3]],"date-time":"2024-04-03T00:18:57Z","timestamp":1712103537000},"page":"1229-1237","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":36,"title":["Capivasertib: A Novel AKT Inhibitor Approved for Hormone-Receptor-Positive, HER-2-Negative Metastatic Breast Cancer"],"prefix":"10.1177","volume":"58","author":[{"given":"Alexa J.","family":"Luboff","sequence":"first","affiliation":[{"name":"Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2207-9552","authenticated-orcid":false,"given":"David L.","family":"DeRemer","sequence":"additional","affiliation":[{"name":"Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA"},{"name":"University of Florida Health Cancer Center, Gainesville, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,4,2]]},"reference":[{"key":"bibr1-10600280241241531","unstructured":"Cancer.Net. Breast cancer\u2014statistics. 2023. Accessed December 19, 2023. https:\/\/www.cancer.net\/cancer-types\/breast-cancer"},{"key":"bibr2-10600280241241531","unstructured":"National Comprehensive Cancer Network. Breast cancer (Version 5.2023). Accessed December 15, 2023. https:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/breast.pdf"},{"key":"bibr3-10600280241241531","doi-asserted-by":"publisher","DOI":"10.3390\/ijms222212292"},{"key":"bibr4-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1016\/j.mce.2021.111322"},{"key":"bibr5-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-19-1390"},{"key":"bibr6-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-18-0830"},{"key":"bibr7-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1038\/ncomms11479"},{"key":"bibr8-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1813904"},{"key":"bibr9-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdu456"},{"key":"bibr10-10600280241241531","unstructured":"U.S. Food and Drug Administration. FDA approves capivasertib with fulvestrant for breast cancer. Accessed December 15, 2023. https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-capivasertib-fulvestrant-breast-cancer"},{"key":"bibr11-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2019.1676726"},{"key":"bibr12-10600280241241531","doi-asserted-by":"publisher","DOI":"10.3390\/cancers13143445"},{"key":"bibr13-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-08-1253"},{"key":"bibr14-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1021\/jm301762v"},{"key":"bibr15-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-11-0824-T"},{"key":"bibr16-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-15-0143"},{"key":"bibr17-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-015-2795-7"},{"key":"bibr18-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-17-2260"},{"key":"bibr19-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-016-2987-9"},{"key":"bibr20-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-018-3558-z"},{"key":"bibr21-10600280241241531","unstructured":"Truqap (capivasertib). AstraZeneca, Inc.; 2023."},{"key":"bibr22-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15831"},{"key":"bibr23-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1307"},{"key":"bibr24-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-19-3953"},{"key":"bibr25-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(19)30817-4"},{"key":"bibr26-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.19.00368"},{"key":"bibr27-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2019.11.006"},{"key":"bibr28-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(20)30444-7"},{"key":"bibr29-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdz086"},{"key":"bibr30-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2020.6741"},{"key":"bibr31-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(22)00284-4"},{"key":"bibr32-10600280241241531","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2214131"},{"key":"bibr33-10600280241241531","volume-title":"Paper presented at the 2023 San Antonio Breast Cancer Symposium","author":"Hamilton E"}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280241241531","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10600280241241531","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280241241531","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:13:39Z","timestamp":1777374819000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10600280241241531"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,2]]},"references-count":33,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["10.1177\/10600280241241531"],"URL":"https:\/\/doi.org\/10.1177\/10600280241241531","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,2]]}}}