Evidence map›Paper›PMID 39087959›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2024

Elacestrant in ER+, HER2- Metastatic Breast Cancer with ESR1-Mutated Tumors: Subgroup Analyses from the Phase III EMERALD Trial by Prior Duration of Endocrine Therapy plus CDK4/6 Inhibitor and in Clinical Subgroups.

Aditya Bardia, Javier Cortés, François-Clément Bidard, Patrick Neven, José Garcia-Sáenz, Phillipe Aftimos, Joyce O'Shaughnessy, Janice Lu, Giulia Tonini, Simona Scartoni and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07753954 (Imaging to Re-evaluate Elacestrant Clinical Application), which is not on this map. Cited by 67 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 4 pooled it
–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.

NCT07753954 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Imaging to Re-evaluate Elacestrant Clinical Application

TypeinterventionalSponsorJules Bordet InstituteRan2026 to 2031Enrolled160ConditionsER+ / HER2- Advanced Breast CancerArmsElacestrant
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. SEOM-GEICAM-SOLTI clinical guidelines in advanced breast cancer (UPDATE 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Guideline
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  8. The journal of liquid biopsy · 2026
    Review
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7 more citing papers are in PubMed but not listed here.

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

14 authors.

Aditya BardiaUniversity of California Los Angeles (UCLA) Health Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California.ORCID 0000-0003-4885-1157
Javier CortésInternational Breast Cancer Center (IBCC), Pangaea Oncology, Quironsalud Group, Barcelona, Spain; and IOB Madrid, Hospital Beata Maria Ana, and Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid, Spain.ORCID 0000-0001-7623-1583
François-Clément BidardInstitut Curie, Paris and Saint Cloud, France.ORCID 0000-0001-5932-8949
Patrick NevenUniversitaire Ziekenhuizen (UZ)-Leuven Cancer Institute, Leuven, Belgium.ORCID 0000-0002-1434-9460
José Garcia-SáenzInstituto de Investigación Sanitaria Hospital Clinico San Carlos (IdISSC), Madrid, Spain.ORCID 0000-0001-6880-0301
Phillipe AftimosInstitut Jules Bordet-Université Libre de Bruxelles, Brussels, Belgium.ORCID 0000-0001-9946-4726
Joyce O'ShaughnessyBaylor University Medical Center, Texas Oncology, US Oncology, Dallas, Texas.ORCID 0000-0002-2955-5523
Janice LuNorthwestern University Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois.ORCID 0009-0006-8926-6367
Giulia ToniniMenarini Group, Florence, Italy.ORCID 0009-0004-4835-4059
Simona ScartoniMenarini Group, Florence, Italy.ORCID 0009-0005-3306-4689
Alessandro PaoliMenarini Group, Florence, Italy.ORCID 0000-0002-1128-6839
Monica BinaschiMenarini Group, Florence, Italy.ORCID 0000-0002-3155-3164
Tomer WassermanMenarini Group, Florence, Italy.ORCID 0009-0007-2468-8371
Virginia KaklamaniUniversity of Texas Health Sciences Center, San Antonio, Texas.ORCID 0000-0002-3313-8458

Funding

Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Robert Damoiseaux · 1985 to 2026
$134.5M
NCI NIH HHS P30 CA016042
6 · The paper itself

Abstract

purposeElacestrant significantly prolonged progression-free survival (PFS) with manageable safety versus standard-of-care (SOC) endocrine therapy (ET) in patients with estrogen receptor-positive (ER+), HER2- metastatic breast cancer and tumors harboring estrogen receptor 1 (ESR1) mutation following ET plus a cyclin-dependent kinase 4/6 inhibitor (ET+CDK4/6i). In patients with ESR1-mutated tumors, we evaluated the efficacy and safety of elacestrant versus SOC based on prior ET+CDK4/6i duration and in clinical subgroups with prior ET+CDK4/6i ≥12 months. PATIENTS AND

methodsEMERALD, an open-label phase III trial, randomly assigned patients with ER+, HER2- metastatic breast cancer who had received 1-2 prior lines of ET, mandatory CDK4/6i, and ≤1 chemotherapy to elacestrant (345 mg daily) or SOC (aromatase inhibitor or fulvestrant). PFS was assessed across subgroups in post hoc exploratory analyses without adjustment for multiple testing.

resultsIn patients with ESR1-mutated tumors and prior ET+CDK4/6i ≥12 months, the median PFS for elacestrant versus SOC was 8.6 versus 1.9 months (HR, 0.41; 95% confidence interval, 0.26-0.63). In this population, the median PFS (in months) for elacestrant versus SOC was 9.1 versus 1.9 (bone metastases), 7.3 versus 1.9 (liver and/or lung metastases), 9.0 versus 1.9 (<3 metastatic sites), 10.8 versus 1.8 (≥3 metastatic sites), 5.5 versus 1.9 (PIK3 catalytic subunit α mutation), 8.6 versus 1.9 (tumor protein p53 gene mutation), 9.0 versus 1.9 (HER2-low), 9.0 versus 1.9 (ESR1D538G-mutated tumors), and 9.0 versus 1.9 (ESR1Y537S/N-mutated tumors). Subgroup safety was consistent with the overall population.

conclusionsThe duration of prior ET+CDK4/6i ≥12 months in metastatic breast cancer was associated with a clinically meaningful improvement in PFS for elacestrant compared with SOC and was consistent across all subgroups evaluated in patients with ER+, HER2-, ESR1-mutated tumors.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Erb-b2 Receptor Tyrosine KinasesEstrogen Receptor alphaMutationAdultAgedFemaleHumansMiddle AgedNeoplasm MetastasisPiperazinesProtein Kinase InhibitorsReceptors, EstrogenCDK4 protein, humanCDK6 protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6ERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesESR1 protein, humanEstrogen Receptor alphaPiperazinesProtein Kinase InhibitorsReceptors, Estrogen

Identifiers

PMID39087959
PMCPMC11443208

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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 Socratic graph.