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Elacestrant, a new generation FDA-approved oral selective estrogen receptor degrader (SERD) and antagonist, has demonstrated efficacy in a subset of women with advanced HR+breast cancer, but there are few patient-derived models to characterize its effect in advanced cancers with diverse treatment histories and acquired mutations.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We analyzed clinical outcomes with elacestrant, compared with endocrine therapy, among women who had previously been treated with a fulvestrant-containing regimen from the recent phase 3 EMERALD Study. We further modeled sensitivity to elacestrant, compared with the currently approved SERD, fulvestrant in patient-derived xenograft (PDX) models and cultured circulating tumor cells (CTCs).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Analysis of the subset of breast cancer patients enrolled in the EMERALD study who had previously received a fulvestrant-containing regimen indicates that they had better progression-free survival with elacestrant than with standard-of-care endocrine therapy, a finding that was independent estrogen receptor <jats:italic>(ESR1)<\/jats:italic> gene mutations. We modeled elacestrant responsiveness using patient-derived xenograft (PDX) models and in ex vivo cultured CTCs derived from patients with HR+breast cancer extensively treated with multiple endocrine therapies, including fulvestrant. Both CTCs and PDX models are refractory to fulvestrant but sensitive to elacestrant, independent of mutations in <jats:italic>ESR1<\/jats:italic> and Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (<jats:italic>PIK3CA)<\/jats:italic> genes.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Elacestrant retains efficacy in breast cancer cells that have acquired resistance to currently available ER targeting therapies. Elacestrant may be an option for patients with HR+\/HER2- breast cancer whose disease progressed on fulvestrant in the metastatic setting.<\/jats:p>\n                <jats:p>Translational Relevance.<\/jats:p>\n                <jats:p>Serial endocrine therapy is the mainstay of management for metastatic HR+breast cancer, but acquisition of drug resistance highlights the need for better therapies. Elacestrant is a recently FDA-approved novel oral selective estrogen receptor degrader (SERD), with demonstrated efficacy in the EMERALD phase 3 clinical trial of refractory HR+breast cancer. Subgroup analysis of the EMERALD clinical trial identifies clinical benefit with elacestrant in patients who had received prior fulvestrant independent of the mutational status of the <jats:italic>ESR1<\/jats:italic> gene, supporting its potential utility in treating refractory HR+breast cancer. Here, we use pre-clinical models, including ex vivo cultures of circulating tumor cells and patient-derived xenografts, to demonstrate the efficacy of elacestrant in breast cancer cells with acquired resistance to fulvestrant.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10549-023-06998-w","type":"journal-article","created":{"date-parts":[[2023,6,15]],"date-time":"2023-06-15T05:01:45Z","timestamp":1686805305000},"page":"43-56","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Modeling the novel SERD elacestrant in cultured fulvestrant-refractory HR-positive breast circulating tumor cells"],"prefix":"10.1007","volume":"201","author":[{"given":"Taronish D.","family":"Dubash","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aditya","family":"Bardia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Chirn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brittany A.","family":"Reeves","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph A.","family":"LiCausi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Risa","family":"Burr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben S.","family":"Wittner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumit","family":"Rai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hitisha","family":"Patel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teeru","family":"Bihani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heike","family":"Arlt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francois-Clement","family":"Bidard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia G.","family":"Kaklamani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Aftimos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Cort\u00e9s","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Scartoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessio","family":"Fiascarelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Binaschi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nassir","family":"Habboubi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. 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Abstract PD13\u201304 2022.","DOI":"10.1158\/1538-7445.SABCS22-PD13-04"}],"container-title":["Breast Cancer Research and Treatment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10549-023-06998-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10549-023-06998-w\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10549-023-06998-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,6,27]],"date-time":"2023-06-27T06:34:35Z","timestamp":1687847675000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10549-023-06998-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,15]]},"references-count":38,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2023,8]]}},"alternative-id":["6998"],"URL":"https:\/\/doi.org\/10.1007\/s10549-023-06998-w","relation":{},"ISSN":["0167-6806","1573-7217"],"issn-type":[{"value":"0167-6806","type":"print"},{"value":"1573-7217","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,15]]},"assertion":[{"value":"22 March 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 May 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 June 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"A.B. Consultant\/Advisory board: Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics\/Gilead, Sanofi, Daiichi Pharma\/Astra Zeneca, Phillips, Eli Lilly, Foundation Medicine, Contracted Research\/Grant (to institution): Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health, Immunomedics\/Gilead, Daiichi Pharma\/Astra Zeneca, Eli Lilly. A.J.I. received royalties from Invitae, and is a SAB member of Oncoclinicas Brasil, SequreDx, Repare Therapeutics and Kinnate Biopharma. H.A., H.P., and T.B. are former employees and shareholders of Radius Health, Inc. F.C.B. Consulting or Advisory Role: Pfizer, AstraZeneca, Lilly, Novartis, Radius Health, Menarini, Sanofi (Inst), Speakers\u2019 Bureau: Pfizer, Novartis, AstraZeneca, Roche, Lilly, Rain Therapeutics, Research Funding: Novartis (Inst), Pfizer (Inst), Menarini Silicon Biosystems (Inst), Prolynx (Inst), Patents, Royalties, Other Intellectual Property: ESR1 & MSI detection techniques (patents; Inst) and Travel, Accommodation Expenses: Roche, Pfizer, AstraZeneca, Novartis. V.G.K. Honoraria: Genentech, Novartis, Pfizer, Genomic Health, Puma Biotechnology, AstraZeneca, Seattle Genetics, daichi, Gilead Sciences, Consulting or Advisory Role: Amgen, Eisai, Puma Biotechnology, Celldex, AstraZeneca, Athenex, bioTheranostics, Speakers\u2019 Bureau: Genentech, Novartis, Genomic Health, Puma Biotechnology, Pfizer, AstraZeneca\/Daiichi Sankyo and Research Funding: Eisai. P.A. Honoraria: Synthon, Roche, Gilead Sciences, Consulting or Advisory Role: Macrogenics, Boehringer Ingelheim, Novartis, Amcure, Roche, Novartis, Amgen, Servier, G1 Therapeutics, Radius Health, Deloitte, Menarini, Gilead Sciences and Travel, Accommodations Expenses: Amgen, MSD Oncology, Roche Belgium, Pfizer. J.C. Stock and Other Ownership Interests: MedSIR, Nektar, Leuko, Honoraria: Novartis, Eisai, Celgene, Pfizer, Roche, Samsung, Lilly, Merck Sharp & Dohme, Daiichi Sankyo, Consulting or Advisory Role: Celgene, Cellestia Biotech, AstraZeneca, Roche, Seattle Genetics, Daiichi Sankyo, ERYTECH Pharma, Polyphor, Athenex, Lilly, Servier, Merck Sharp & Dohme, GlaxoSmithKline, Leuko, Clovis Oncology, Bioasis, Boehringer Ingelheim, Ellipses Pharma, HiberCell, Bioinvent, GEMoaB, Gilead Sciences, Menarini, Zymeworks, Reveal Genomics, Research Funding: ARIAD (Inst), Astrazeneca (Inst), Baxalta (Inst), Bayer (Inst), Eisai (Inst), Guardant Health (Inst), Merck Sharp & Dohme (Inst), Pfizer (Inst), Puma Biotechnology (Inst), Queen Mary university of London (Inst), Roche (Inst), Piqur (Inst), Patents, Royalties, Other Intellectual Property: Pharmaceutical Combinations of A Pi3k Inhibitor And A Microtubule Destabilizing Agent. Javier Cort\u00e9s Cast\u00e1n, Alejandro Piris Gim\u00e9nez, Violeta Serra Elizalde. WO 2014\/199294 A, Her2 as a predictor of response to dual HER2 blockade in the absence of cytotoxic therapy. Aleix Prat, Antonio Llombart, Javier Cort\u00e9s. US 2019\/ 0338368 A1 and Travel, Accommodations Expenses: Roche, Pfizer, Eisai, Novartis, Daiichi Sankyo, Gilead Sciences. S.S., A.F., M.B., and N.H. are employees of Menarini Ricerche. M.T., D.A.H., and S.M. are founders of and own equity in TellBio, Inc., which is involved with CTC diagnostics and therapeutics. No funding was received from TellBio, Inc. for this work. No disclosures were reported by the other authors.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Patients provided written informed consent to an Institutional Review Board approved blood collection protocol (DF\/HCC 05\u2013300).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}