Evidence map›Paper›PMID 39377773›Full record

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

A Preoperative Window-of-Opportunity Study of Oral SERD, Imlunestrant, in Newly Diagnosed ER-Positive, HER2-Negative Early Breast Cancer: Results from the EMBER-2 Study.

Patrick Neven, Nicole Stahl, Maria Vidal, Miguel Martín, Peter A Kaufman, Nadia Harbeck, Kelly K Hunt, Stacey Carter, Francois-Clement Bidard, Peter A Fasching and 15 more

Abstract readRandomized Controlled Trial
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. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. 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

25 authors.

Patrick NevenLeuven Cancer Institute, Universitaire Ziekenhuizen (UZ), Leuven, Belgium.ORCID 0000-0002-1434-9460
Nicole StahlHelios Kliniken Schwerin, Schwerin, Germany.ORCID 0009-0002-9192-522X
Maria VidalDepartment of Medical Oncology, Hospital Clinic, Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Barcelona, Spain.ORCID 0000-0003-1992-5727
Miguel MartínDepartment of Medical Oncology, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.ORCID 0000-0001-9237-3231
Peter A KaufmanUniversity of Vermont Cancer Center, Burlington, Vermont.ORCID 0000-0003-3677-6807
Nadia HarbeckBreast Center, Department of Obstetrics and Gynecology, and Comprehensive Cancer Center CCCLMU, Ludwig-Maximilians-University Hospital, Munich, Germany.ORCID 0000-0002-9744-7372
Kelly K HuntDepartment of Breast Surgical Oncology, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-9156-8723
Stacey CarterDivision of Surgical Oncology, Baylor College of Medicine, Lester and Sue Smith Breast Center, Dan L. Duncan Comprehensive Cancer Center, Houston, Texas.ORCID 0009-0005-1735-0431
Francois-Clement BidardDepartment of Medical Oncology, Institute Curie, University Paris-Saclay, St Cloud, France.ORCID 0000-0001-5932-8949
Peter A FaschingDepartment of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.ORCID 0000-0003-4885-8471
Philippe AftimosDepartment of Medical Oncology, Institute Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.ORCID 0000-0001-9946-4726
Duncan WheatleyRoyal Cornwall Hospital, Truro, United Kingdom.ORCID 0000-0002-1919-5114
Erika HamiltonSarah Cannon Research Institute, Nashville, Tennessee.ORCID 0000-0002-1911-0336
Rebecca AftDepartment of Surgery, Washington University School of Medicine, St. Louis, Missouri.ORCID 0000-0001-8569-7131
Swati KulkarniDepartment of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.ORCID 0000-0002-4213-0933
Peter SchmidBarts Cancer Institute, Queen Mary University of London, London, United Kingdom.ORCID 0000-0001-9817-5228
Manali BhaveDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia.ORCID 0000-0003-4020-5871
Roohi Ismail-KhanLoxo@Lilly, Lilly Corporate Center, Indianapolis, Indiana.ORCID 0000-0002-1301-6736
Claudia KaracsonyiLoxo@Lilly, Lilly Corporate Center, Indianapolis, Indiana.ORCID 0009-0004-9265-6644
Shawn T EstremLoxo@Lilly, Lilly Corporate Center, Indianapolis, Indiana.ORCID 0009-0008-5173-6524
Bastien NguyenLoxo@Lilly, Lilly Corporate Center, Indianapolis, Indiana.ORCID 0000-0002-6166-4746
Umut OzbekEli Lilly and Company, Indianapolis, Indiana.ORCID 0000-0002-9034-7416
Eunice YuenEli Lilly and Company, Indianapolis, Indiana.ORCID 0000-0003-2145-6368
Vanessa Rodrik-OutmezguineEli Lilly and Company, Indianapolis, Indiana.ORCID 0009-0006-3219-1181
Eva CiruelosMedical Oncology Department, Breast Cancer Unit, University Hospital 12 de Octubre, Madrid, Spain.ORCID 0000-0002-2796-1042

Funding

Eli Lilly and Company (Lilly)
6 · The paper itself

Abstract

purposeImlunestrant is an oral selective estrogen receptor degrader with favorable safety and preliminary efficacy in patients with advanced breast cancer. Pharmacodynamic (PD) biomarker data can optimize drug dosing; in this study, we present PD data from the EMBER-2 study. PATIENTS AND

methodsPostmenopausal women with untreated, operable estrogen receptor (ER)-positive, HER2-negative early breast cancer were randomized to 400 versus 800 mg of imlunestrant daily for ∼2 weeks before surgery. A single arm study tested a daily dose of 200 mg. PD biomarker changes (ER, progesterone receptor, Ki-67 by IHC, and mRNA expression of ER-related genes) were evaluated in paired tumor samples (pre-/posttreatment). Safety and pharmacokinetics were also assessed.

resultsAmong evaluable paired samples (n = 75), PD profiles demonstrated consistent ER targeting between 400- and 800-mg doses, with less toxicity at the 400-mg dose. Although inducing the lowest rate of complete cell-cycle arrest, PD and pharmacokinetic results were similar for the 200-mg dose.

conclusionsEMBER-2 combined with existing phase I data has identified 400 mg as the optimal imlunestrant dose.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenAdministration, OralAdultAgedAged, 80 and overBiomarkers, TumorEstradiolFemaleHumansMiddle AgedReceptors, ProgesteroneTreatment OutcomeBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesEstradiolReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID39377773
PMCPMC11609621

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.