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Circulating tumor cells (CTCs) are a prognostic marker, but their role in predicting response to specific MBC treatments is less clear. In this trial, we assessed the clinical outcome and its association with CTC-dynamics in HER2-negative MBC treated with eribulin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and methods<\/jats:title>\n                    <jats:p>HER2-negative MBC-patients were screened for CTCs within the DETECT study program using the CellSearch\u00ae technology (Menarini Silicon Biosystems; Bologna, Italy). Patients with HER2-negative CTCs were eligible for the single-arm DETECT-IVb study treatment with eribulin. Primary endpoint was progression-free survival (PFS), and secondary endpoints included overall survival (OS), CTC-clearance rate and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Median PFS and OS were 4.6 months and 13.4 months, respectively. Multivariable adjusted analyses showed that patients with CTC-clearance at first follow-up (34.7%) had significantly improved PFS (p = 0.043) but not OS (p = 0.192) compared to patients with at least 1 CTC. Likewise, patients with CTC-clearance at the end of the treatment (23.1%) achieved a significantly better PFS (p = 0.015) but not OS (p = 0.218). Neutropenia, leukopenia, anemia and fatigue were the most common adverse events and no new or unexpected safety signals were obtained.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In this trial, we could confirm eribulin as an effective treatment option in high-risk HER2-negative MBC. CTCs proved their role as a prognostic marker and our results support the potential role of CTC dynamics as an early biomarker of treatment response to eribulin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      EudraCTNo2013-001269-18\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\" ext-link-type=\"uri\">http:\/\/ClinicalTrials.gov<\/jats:ext-link>\n                      , TRN NCT02035813, Registration date 2014-01-12.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10549-026-08069-2","type":"journal-article","created":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T04:29:08Z","timestamp":1789532948000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy, safety and circulating tumor cell dynamics in patients treated with Eribulin for HER2-negative advanced breast cancer \u2013 results from the phase II DETECT IVb trial"],"prefix":"10.1007","volume":"219","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3675-6494","authenticated-orcid":false,"given":"F.","family":"Schochter","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.W.P.","family":"Friedl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Sch\u00e4ffler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Meier-Stiegen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.N.","family":"Pfister","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Riethdorf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Wiesm\u00fcller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Neubauer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"M\u00fcller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Wimberger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.A.","family":"Fasching","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Lorenz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Hempel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Heublein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Hartkopf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Pantel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"Rack","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"M\u00fcller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Fehm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.","family":"Janni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.P.","family":"Cieslik","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,9,16]]},"reference":[{"issue":"1","key":"8069_CR1","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1093\/annonc\/mdw544","volume":"28","author":"F El Cardoso","year":"2017","unstructured":"Cardoso F, Costa A, Senkus E, Aapro M, Andr\u00e9 F, Barrios C, Bergh J, Bhattacharyya G, Biganzoli L, Cardoso M, Carey L, Corneliussen-James D, Curigliano G, Dieras V, El Saghir N, Eniu A, Fallowfield L, Fenech D (2017) P. 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Cancers 12(12):3735","journal-title":"Cancers"}],"container-title":["Breast Cancer Research and Treatment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10549-026-08069-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10549-026-08069-2","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10549-026-08069-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T04:29:12Z","timestamp":1789532952000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10549-026-08069-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,16]]},"references-count":37,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["8069"],"URL":"https:\/\/doi.org\/10.1007\/s10549-026-08069-2","relation":{},"ISSN":["0167-6806","1573-7217"],"issn-type":[{"value":"0167-6806","type":"print"},{"value":"1573-7217","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,16]]},"assertion":[{"value":"20 April 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"25 August 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 September 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"During the preparation of this manuscript, the authors used ChatGPT for language refinement and phrasing. After using this tool\/service, the authors reviewed and edited the content as needed and take full responsibility for the content of the published article.","order":1,"name":"Ethics","label":"Generative AI and AI-assisted technologies in the manuscript preparation process","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Fabienne Schochter received institutional research funding for from Roche, Pfizer, AstraZeneca, GSK, MSD, AbbVie, Eisai; received speaker and consultant honoraria from Roche, GSK, AstraZeneca, MSD, Eisai; received travel support form MSD, Abbvie and AstraZeneca and served on advisory boards for AstraZeneca, GSK, MSD and Roche; unrelated to this work; Thomas W.P. Friedl: Honoraria from Novartis and Lilly, unrelated to this work.Sch\u00e4ffler H: Honoraria from Gilead, Novartis. Travel expenses from Novartis, Gilead and Daichi Sankyo.Meier-Stiegen F: No conflict of interestPfister KN: Honoraria from Gilead Sciences, Novartis and PfizerRiethdorf S: No conflict of interestWiesm\u00fcller L: No conflict of interest.Neubauer H: No conflict of interestM\u00fcller L: No conflict of interestPauline Wimberger has received research funding for institution from Amgen, Abbvie, AstraZeneca, MSD, GlaxoSmithKline, Novartis, Pfizer, Roche Pharma, Clovis, Lilly, honoraria from Amgen, Abbvie, AstraZeneca, MSD, GlaxoSmithKline, Novartis, Pfizer, Roche Pharma, Clovis, TEVA, Eisai, Lilly, Gilead, Daichii Sankyo. PW participates at advisory boards from Amgen, Abbvie, AstraZeneca, MSD, GlaxoSmithKline, Novartis, Pfizer, Roche Pharma, Clovis, TEVA, Eisai, Lilly, Gilead and Daichii Sankyo; all unrelated to this work. Fasching PA: Personal fees from Novartis, grants from Biontech, grants and personal fees from Pfizer, personal fees from Daiichi-Sankyo, personal fees from Astra Zeneca, personal fees from Eisai, personal fees from Merck Sharp & Dohme, grants from Cepheid, personal fees from Lilly, personal fees from SeaGen, personal fees from Roche, personal fees from Agendia, personal fees from Gilead, personal fees from Mylan, personal fees from Menarini, personal fees from Veracyte, personal fees from GuardantHealth, during the conduct of the study; and Translational Research in Oncology (TRIO).Lorenz R: has received travel support from Daichii Sankyo.Hempel T: No conflict of interestHeublein S: Research funding from Novartis and honoraria from Roche, Pfizer, AstraZeneca, GSK, Novartis, MSD, Clovis, Immunogen, AbbVie, Eisai, Menarini, Pharmaand, Gilead, Daiichi Sankyo; SH participated in advisory activity from MSD, Novartis, GSK, Roche, AbbVie, Daiichi Sankyo and AstraZeneca and received travel grants form GSK, Novartis, AstraZeneca, and Pfizer. Hartkopf A: has received personal fees from Amgen, AstraZeneca, MSD, GlaxoSmithKline, Novartis, Roche Pharma, Lilly, Onkowissen, Agendia, Exact Science, Riemser, TEVA, Gilead, Menarini Stemline, Pfizer, Pierre Fabre and Daichii Sankyo; honoraria from Amgen, AstraZeneca, Agendia, ExactScience, MSD, GlaxoSmithKline, Novartis, Pfizer, Pierre Fabre, Roche Pharma, TEVA, Eisai, Lilly, Onkowissen, Riemser, Seagen, Gilead, Menarini Stemline, Thieme, Veracyte Springer, Daichii Sankyo; received travel support from Roche, Novartis, Lilly AstraZeneca, GSK, ExactScience. Gilead, Menarini Stemline, Pfizer, Daichii Sankyo; all unrelated to this work.Pantel K: Grant\/Research support from: EU\/IMI GUIDE.MRD EFPIA, EU PANCAID, ERC; Honoraria from: NRICH, BMS, Menarini, Novartis, Roche, MSD, Guardant HealthRack B: Honoraria and research funding by AstraZeneca and Novartis M\u00fcller V: 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, ClinSol, Novartis, MSD, Daiichi-Sankyo, Eisai, Lilly, Gilead, Stemline; Institutional research support: Novartis, Roche, Seagen, Genentech, Astra Zeneca, Pfizer; Travel grants: Astra Zeneca, Roche, Pfizer, Daiichi Sankyo, Gilead; all unrelated to this work.Fehm T: has received personal fees from Onkowissen, FOMF, Medconcept and honoraria (inst) from Novartis, Roche, Pfizer, MSD, EIsai, AstraZeneca, Daichii Sankyo.TF participates at advisory boards from AstraZeneca, MSDand Daichii Sankyoa and received travel support from Roche, Pfizer, Daichii Sankyo; all unrelated to this work.Janni W: Honoraria and\/or research funding by AstrsaZeneca, Cellgene, Chugai, DaiichiSankyo, Aisai, ExactScience, GSK, Janssen, Lilly, Menarini, MSD; Novartis, Sanofi-Aventis, Roche, Pfizer, Seagen, Gilead, Inivata, Guardant HealthCieslik JP: No conflict of interest.","order":2,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"12"}}