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This study examined the potential protective effects of montelukast (ML), an anti-asthmatic drug with anti-inflammatory characteristics, against doxorubicin-induced cardiotoxicity (DIC) in breast cancer (BC) patients.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Method<\/jats:title>\n            <jats:p>A prospective, randomized, controlled clinical study including fifty individuals with a confirmed diagnosis of BC, individuals scheduled to receive DOX 60 mg\/m<jats:sup>2<\/jats:sup> in conjunction with Cyclophosphamide 600 mg\/m<jats:sup>2<\/jats:sup> (AC) for four courses at 21-day intervals. Both the control group and the ML group were randomly\u00a0selected\u00a0from the patient pool.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>After treatment, a significant reduction in N-terminal Pro Brain Natriuretic Peptide (NT pro-BNP) levels was observed in the ML group compared to the control group (1756.0 [1054.0\u20132334.0] vs. 3788.0 [2226.0\u20134401.1] pg\/mL, p\u2009&lt;\u20090.001). Nuclear factor-kappa B (NF-\u03baB) levels also decreased significantly in the ML group (2.23 [1.18\u20133.05] vs. 3.11 [2.39\u20133.25] pg\/mL, p\u2009=\u20090.009). The median percentage reduction in Soluble suppression of tumorigenicity 2 (sST2) levels was more pronounced in the ML group (20.93\u2009\u00b1\u20095.45 ng\/mL) than in the control group (24.16\u2009\u00b1\u20095.14 ng\/mL, p\u2009=\u20090.036). Additionally, a strong positive correlation between NT pro-BNP and NF-\u03baB levels was observed post-treatment (rs\u2009=\u20090.644, p\u2009&lt;\u20090.001), supporting ML\u2019s potential anti-inflammatory and cardioprotective effects.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>The incorporation of ML into AC led to a substantial decrease in cardiac biomarkers confirming the feasibility of incorporating ML in individuals with breast cancer as an auxiliary treatment to prevent DOX-induced cardiotoxicity.<\/jats:p>\n            <jats:p>\n              <jats:bold>Trial registration<\/jats:bold> ClinicalTrials.gov: NCT05959889.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s00520-025-09947-z","type":"journal-article","created":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T18:56:43Z","timestamp":1759345003000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Evaluating the role of montelukast on doxorubicin-induced cardiotoxicity in breast cancer patients"],"prefix":"10.1007","volume":"33","author":[{"given":"Naglaa F.","family":"Gomaa","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5983-3993","authenticated-orcid":false,"given":"Rehab H.","family":"Werida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed G.","family":"EL-Gowily","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9277-2910","authenticated-orcid":false,"given":"Noha A.","family":"El-Bassiouny","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,10,1]]},"reference":[{"key":"9947_CR1","first-page":"477","volume":"74","author":"AN Giaquinto","year":"2024","unstructured":"Giaquinto AN, Sung H, Newman LA, Freedman RA, Smith RA, Star J, Jemal A, Siegel RL (2024) Breast cancer statistics 2024. 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