Evidence map›Paper›PMID 39820652›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025

Elacestrant in Women with Estrogen Receptor-Positive and HER2-Negative Early Breast Cancer: Results from the Preoperative Window-of-Opportunity ELIPSE Trial.

Maria Vidal, Claudette Falato, Tomás Pascual, Rodrigo Sanchez-Bayona, Montserrat Muñoz-Mateu, Isaac Cebrecos, Xavier Gonzalez-Farré, Tomás Cortadellas, Mireia Margelí Vila, Miguel A Luna and 11 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Maria VidalSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0003-1992-5727
Claudette FalatoSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0003-4055-4764
Tomás PascualSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0001-8431-3183
Rodrigo Sanchez-BayonaSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0002-5255-6620
Montserrat Muñoz-MateuSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0001-7772-1437
Isaac CebrecosCancer Institute and Blood Disorders, Hospital Clinic de Barcelona, Barcelona, Spain.ORCID 0000-0002-9333-3642
Xavier Gonzalez-FarréInstituto Oncológico Dr. Rosell, Hospital General de Catalunya, Barcelona, Spain.ORCID 0000-0002-5797-7037
Tomás CortadellasBreast Unit, Department of Obstetrics and Gynaecology, Hospital Universitari General de Catalunya, Barcelona, Spain.ORCID 0000-0001-7225-7954
Mireia Margelí VilaSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0003-3594-4530
Miguel A LunaB-ARGO Group, Medical Oncology Department, ICO Badalona, Germans Trias I Pujol Institute, Badalona, Spain.ORCID 0000-0002-9253-3677
Christian SisoVall d'Hebron University Hospital, Barcelona, Spain.ORCID 0000-0002-7217-1541
Kepa AmillanoHospital Universitari Sant Joan de Reus, Barcelona, Spain.ORCID 0000-0002-4961-9328
Patricia GalvánTranslational Genomics and Targeted Therapies in Solid Tumor, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.ORCID 0000-0002-8153-0307
Milana A BergaminoSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0002-1091-2711
Juan M Ferrero-CafieroSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0001-8796-8812
Fernando SalvadorSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0002-5442-1754
Alejandra Espinosa GuerreroSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0002-7193-9563
Laia PareSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0002-4904-558X
Esther SanfeliuTranslational Genomics and Targeted Therapies in Solid Tumor, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.ORCID 0000-0002-7974-3346
Aleix PratCancer Institute and Blood Disorders, Hospital Clinic de Barcelona, Barcelona, Spain.ORCID 0000-0003-2377-540X
Meritxell BelletSOLTI Cancer Research Group, Barcelona, Spain.ORCID 0000-0001-8859-8307

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeElacestrant has shown significantly prolonged progression-free survival compared with standard-of-care endocrine therapy in estrogen receptor-positive (ER-positive), HER2-negative metastatic breast cancer, whereas potential benefit in early-stage disease requires further exploration. The SOLTI-ELIPSE window-of-opportunity trial investigated the biological changes induced by a short course of preoperative elacestrant in postmenopausal women with early breast cancer. PATIENTS AND

methodsEligible patients with untreated T1c (≥1.5 cm)-T3, N0, ER-positive/HER2-negative breast cancer with locally assessed Ki67 ≥10% received elacestrant at a daily dose of 345 mg for 4 weeks. The primary efficacy endpoint was complete cell cycle arrest, defined as Ki67 ≤2.7%, on day 28.

resultsOverall, 22 patients were evaluable for the primary endpoint. Elacestrant was associated with a complete cell cycle arrest rate of 27.3% and a statistically significant Ki67 geometric mean change of -52.9% (P = 0.007; 95% confidence interval, -67.4 to -32.1). Notably, the treatment with elacestrant led to a shift toward a more endocrine-sensitive and less proliferative tumor phenotype based on PAM50-based gene signatures. Elacestrant increased the expression of immune-response genes (GZMB, CD4, and CD8A) and suppressed proliferation and estrogen-signaling genes (MKI67, ESR1, and AR). These biological changes were independent of the levels of Ki67 suppression on day 28. The most common adverse events were grade 1 anemia (21.7%), hot flushes (8.7%), constipation (8.7%), and abdominal pain (8.7%). One patient experienced a grade 3 cutaneous rash, leading to treatment discontinuation. No other serious adverse events were reported.

conclusionsPreoperative treatment with elacestrant in early breast cancer demonstrated relevant biological and molecular responses and exhibited a manageable safety profile. These findings support further investigation of elacestrant in the early setting.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenAdultAgedBiomarkers, TumorFemaleHumansKi-67 AntigenMiddle AgedNeoplasm StagingTreatment OutcomeBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesKi-67 AntigenReceptors, Estrogen

Identifiers

PMID39820652
PMCPMC11959270

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.