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Alpelisib in combination with fulvestrant was the first approved PI3K inhibitor and was introduced in clinical practice in 2019. A lack of evidence for the use of alpelisib in the context of current treatment options like cyclin-dependent 4\/6 inhibitor (CDK4\/6i), highlights the importance of this analysis. We provide a real-world analysis of the use of alpelisib with the prospective German PRAEGNANT registry (NCT02338167).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      57 patients with advanced breast cancer receiving alpelisib and fulvestrant were identified. 55 Patients had received prior CDK4\/6i therapy. Progression-free survival (PFS) and overall survival (OS) were calculated for all patients, and stratified according CDK4\/6i pre-treatment, using the Kaplan\u2013Meier method. Subgroups (age, line of therapy, concomitant disease among others), somatic\n                      <jats:italic>PIK3CA<\/jats:italic>\n                      mutations, reasons for discontinuation and adverse events (AEs) were analyzed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The median PFS was 5.0 (95% confidence interval [CI], 3.1\u20139.4) months, and the median OS was 20.1 (95% CI, 14.6\u201330.8) months. Line of therapy and concomitant diseases appeared to affect PFS, while the line of therapy and preexisting diabetes influenced OS. However, subgroups were too small for statistical testing. Discontinuation was mainly due to tumor progression (56.1%). Hyperglycemia, rash and diarrhea were the most documented AEs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This prospective real-world analysis shows slightly shorter median PFS and OS times compared with the pivotal trials. Patients in our analyses received alpelisib in later therapy lines, which may explain the poorer outcome.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10549-026-07939-z","type":"journal-article","created":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T08:14:55Z","timestamp":1775117695000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Alpelisib and Fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial"],"prefix":"10.1007","volume":"217","author":[{"given":"Manuel","family":"H\u00f6rner","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lara 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Breast 80:104412","journal-title":"Breast"}],"container-title":["Breast Cancer Research and Treatment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10549-026-07939-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10549-026-07939-z","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10549-026-07939-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T07:36:29Z","timestamp":1777880189000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10549-026-07939-z"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,2]]},"references-count":35,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["7939"],"URL":"https:\/\/doi.org\/10.1007\/s10549-026-07939-z","relation":{},"ISSN":["0167-6806","1573-7217"],"issn-type":[{"value":"0167-6806","type":"print"},{"value":"1573-7217","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,2]]},"assertion":[{"value":"24 October 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 March 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 April 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"M.H. received research support from Helsinn Healthcare SA, honoraria from Lilly Deutschland GmbH, Thieme and travel support from Novartis, Lilly Deutschland GmbH, and AstraZeneca. N.A received honoraria for lectures and participation in advisory boards: Gilead, Georg Thieme Verlag and received support for attending meetings from AstraZeneca, Novartis, Pfizer. A.K. received lecture fees from Gilead and Novartis, honoria for written scientific work from Thieme as well as support for attending meetings from Lilly; H.S. received honoraria from Pfizer, Novartis, GILEAD, Lilly, Daiichi, Eickeler Veranstaltungen, Novartis, GILEAD; C.G. received speaker honoraria from Novartis Pharma GmbH and ClinSol GmbH & Co. KG.; C. M. T. received honoraria from AstraZeneca. C.M.T. is a shareholder in Curevac N.V. and BioNTech SE.; S.Y.B. received advisory board honoraria from Lilly und Astra Zeneca; CC.H. received honoraria for lectures from Novartis, Roche, Pfizer, AstraZeneca, Gilead, Eisai, MSD and Daiichi Sankyo; and support for attending meetings from Daiichi Sankyo; V.M. received Speaker honoraria: Astra Zeneca, arsTempi, Daiichi-Sankyo, Eisai, Pfizer, MSD, Medac, Novartis, Roche, Seagen, Onkowissen, high5 Oncology, Lilly, Medscape, Gilead, Pierre Fabre, iMED Institute, Consultancy honoraria: Roche, Pierre Fabre, PINK, ClinSol, Novartis, MSD, Daiichi-Sankyo, Eisai, Lilly, Seagen, Gilead, Stemline, Institutional research support: Novartis, Roche, Seagen, Genentech, Astra Zeneca, Travel grants: Astra Zeneca, Roche, Pfizer, Daiichi Sankyo, Gilead, V.M. is an edititorial board member of the journal The Breast; A.S. received honoraria from Amgen, AstraZeneca, Aurikamed, Bayer, Celgene, ClinSol, Clovis Oncology, coma, UroGyn, Connectmedica, Daiichi Sankyo, Gilead, GSK, if-kongress, I-MED, iOMEDICO, Lilly, MCI Deutschland, med publico, Menarini Stemline, Metaplan, MSD, Mylan, NanoString Technologies, Novartis, onkowissen.de, Pfizer, Pierre Fabre, promedicis, Roche, Seagen, streamedup, SYNLAB, Tesaro and travel support from AstraZeneca, Celgene, Daiichi Sankyo, Gilead, Pfizer, Roche; M.BP. received  honoraria for lectures and advisory boards: Roche, Novartis, Pfizer, pfm, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, Amgen, Samsung, Canon, MSD, GSK, Daiichi Sankyo, Gilead, Sirius Medical, Syantra, resitu, Pierre Fabre, ExactSciences, Aurikamed; Study support: Korean Breast Cancer Society, Eugen & Irmgard Hahn Stiftung, EndoMag, Mammotome, MeritMedical, Sirius Medical, Gilead, Hologic, ExactSciences, Claudia von Schilling Stiftung, Damp Stiftung, Ehmann Stiftung Savognin; Travel expenses: Eli Lilly, ExactSciences, Pierre Fabre, Pfizer, Daiichi Sankyo, Roche, Stemline; A.H. received honoraria from Novartis, MSD as well as support for attending meetings from Daiichi Sankyo and Gilead; A.R. received honoraria for lectures: Roche, Pfizer, Novartis, Celgen, LEO Pharma, Novartis, ExactSciences, Pierre Fabre, Lilly, Seagen, Targos, RG; Advisory Boards: Roche, Astra Zeneca, Pfizer, Celgen, Eisai, Novartis, MSD, Hexal, Amgen, ExactSciences, Pierre Fabre; J.E. Speakers Bureau, Travel Grants or Advisory Boards: AstraZeneca, Daiichi, Eurobio, Gilead, Lilly, Myriad, Pfizer, Seagen; T.F. received travel expenses from Daichii Sanyko, Pfizer, Roche and honoraria from MedConcept, Onkowissen, FOMF; L.L.M. received fees for speaking engagements and accommodation expenses in connection with congress participations from Roche, Pfizer, Lilly Pharma, Daiichi Sankyo, AstraZeneca, Onkowissen, Gilead, Novartis; W.W.J. received research Grants and\/or honoraria from AstraZeneca, Cellgene, Chugai, DaiichiSankyo, Eisai, ExactScience, Gilead, GSK, Guardant Health, Janssen, Lilly, Menarini Stemline, MSD, NeoGenomics, Novartis, Pfizer, Roche, Sanofi-Aventis, Seagen; P.A.F. has received institutional funding from BioNTech, Cepheid and Pfizer and peronal honoraria from Novartis, Pfizer, Roche, Daiichi Sankyo, AstraZeneca, Lilly, Eisai, Merck Sharp & Dohme, Pierre Fabre, SeaGen, Agendia, Sanofi Aventis, Gilead and Mylan for consulting, participation in advisory boards and steering committees and\/or lectures. His institution conducts research for Novartis; N.T. received honoraria for lectures and advisory boards: Novartis, Exact Sciences, Pfizer, Georg Thieme Verlag, if-kongress, Deltamed; Study support: Novartis; Travel expenses: Novartis, Daiichi sankyo, Astra Zeneca, Aurikamed. All remaining authors have nothing to declare.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"All patients included in the present study provided informed consent, and the study was approved by all ethics committees of participating study sites.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}],"article-number":"9"}}