Evidence map›Paper›PMID 42735454›Full record

ArticleESMO open2026

Outcomes of elacestrant in patients with ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer who received prior endocrine therapy and cyclin-dependent kinase inhibitor in a real-world setting.

G Curigliano, M De Laurentiis, N Harbeck, S Kuemmel, J Á García-Sáenz, R Sanchez Bayona, D Rea, A Okines, B Pistilli, E Sears and 4 more

Abstract read
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Article in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

14 authors.

G CuriglianoDepartment of Oncology and Hemato-Oncology, University of Milano, Milano, Italy; European Institute of Oncology, IRCCS, Milano, Italy. Electronic address: giuseppe.curigliano@ieo.it.
M De LaurentiisIstituto Nazionale Tumori IRCCS "Fondazione Pascale," Naples, Italy.
N HarbeckBreast Center, Department of Obstetrics and Gynecology, Comprehensive Cancer Center (CCC) Munich, University of Munich, Munich, Germany.
S KuemmelBreast Unit, Kliniken Essen-Mitte, Essen, Germany.
J Á García-SáenzOncology Department, Hospital Ruber Internacional, Madrid, Spain.
R Sanchez BayonaMedical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
D ReaCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.
A OkinesMedical Oncology, The Royal Marsden NHS Foundation Trust, London, United Kingdom.
B PistilliDepartment of Medical Oncology, Gustave Roussy, Villejuif, France.
E SearsAnalysis Group, New York, NY, USA.
J MaitlandAnalysis Group, Toronto, Canada.
S KlossMenarini Group, Florence, Italy.
T WassermanMenarini Group, New York, NY, USA.
M IgnatiadisDepartment of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Bruxelles, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReal-world data analyses show durable benefits with elacestrant, with or without prior treatment with cyclin-dependent kinase 4/6 inhibitor (CDK4/6i). This cohort focused on patients with ER-positive/HER2-negative estrogen receptor 1 (ESR1)-mutated metastatic breast cancer (mBC) treated with elacestrant after at least one line of endocrine therapy (ET) combined with CDK4/6i (N = 281). PATIENTS AND

methodsClaims data from the Komodo Research Dataset linked with Foundation Medicine clinical-genomics data were used. Primary outcome was median time-to-next-treatment (mTTNT).

resultsIn patients with ER-positive/HER2-negative ESR1-mutated mBC who received one to two prior lines of ET + CDK4/6i (n = 108), mTTNT with elacestrant was 8.2 months [95% confidence interval (CI) 6.0-12.2]. In patients who received one to two prior lines of ET + CDK4/6i for ≥12 months (n = 85), mTTNT was 9.0 months (95% CI 7.7-13.7), including an mTTNT of 12.2 months (95% CI 9.0-not reached) in those who received one prior line of ET (n = 31). In patients with liver and/or lung metastasis (n = 169), mTTNT was 6.9 months (95% CI 5.8-8.3), whereas it was 7.4 months (95% CI 5.6-12.9) in patients with brain metastasis (n = 68). In patients with coexisting ESR1- and phosphoinositide 3-kinase-pathway-mutated tumors (n = 115), mTTNT was 6.1 months (95% CI 5.0-8.1).

conclusionsElacestrant showed durable benefits in patients with ER-positive/HER2-negative ESR1-mutated mBC previously exposed to at least one line of ET + CDK4/6i, reinforcing the role of elacestrant as a potential first-choice option for patients with endocrine-sensitive tumors.

Indexed as

breast cancerelacestrantESR1 mutationmetastatic breast cancerreal-world data

Identifiers

PMID42735454
PMCPMC13594719

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