Evidence map›Paper›PMID 41962306›Full record

Trial reportESMO open2026

Patient-reported outcomes and qualitative interviews in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: results from the phase III EMBER-3 trial.

G Curigliano, J O'Shaughnessy, F-C Bidard, M L Casalnuovo, S-B Kim, E Tokunaga, P Aftimos, C Saura, L A Carey, M Okera and 14 more

Abstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2026. 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. Review
  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

24 authors.

G CuriglianoDepartment of Oncology and Hemato-Oncology, University of Milano, Milan, Italy; European Institute of Oncology, IRCCS, Milan, Italy. Electronic address: giuseppe.curigliano@ieo.it.
J O'ShaughnessyBaylor University Medical Center, Texas Oncology, Sarah Cannon Research Institute, Dallas, USA.
F-C BidardInstitut Curie and University of Versailles-Saint-Quentin, Saint Cloud, France.
M L CasalnuovoHospital María Curie, Buenos Aires, Argentina.
S-B KimAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
E TokunagaNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
P AftimosInstitut Jules Bordet, Hôpital Universitaire de Bruxelles, Brussels, Belgium.
C SauraVall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
L A CareyLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, USA.
M OkeraCancer Research SA, Adelaide, Australia.
E MeloHospital do Câncer de Londrina, Londrina, Brazil.
F ZagouriDepartment of Clinical Therapeutics, Medical School of National and Kapodistrian University of Athens, 'Alexandra' General Hospital of Athens, Athens, Greece.
M Magallanes-MacielCentro Oncologico Internacional, Mexico City, Mexico.
N KaradurmusGülhane Education and Research Hospital, University of Health Sciences, Ankara, Turkey.
S BahadurMayo Clinic Arizona, Pheonix, USA.
R M SpeckEli Lilly and Company, Indianapolis, USA.
X A WangEli Lilly and Company, Indianapolis, USA.
K PradhanEli Lilly and Company, Indianapolis, USA.
J MaceyClarivate, London, UK.
H KitchenClarivate, London, UK.
S FairhurstClarivate, London, UK.
J MillerClarivate, London, UK.
K L JhaveriMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, USA.
N HarbeckBreast Center, Department of Obstetrics and Gynecology, LMU University Hospital Munich, Munich, Germany.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundImlunestrant is a next-generation, brain-penetrant, oral selective estrogen receptor degrader. In the phase III EMBER-3 trial, conducted in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer, imlunestrant demonstrated a significant progression-free survival benefit compared with standard endocrine therapy (standard of care; fulvestrant or exemestane) in patients harboring ESR1 mutations (ESR1m). Additionally, the combination of imlunestrant and abemaciclib improved outcomes compared with imlunestrant monotherapy, irrespective of ESR1m status. This manuscript reports findings from exploratory analyses of patient-reported outcome (PRO) measures and qualitative interviews evaluating EMBER-3 participants' experiences and treatment preferences. MATERIALS AND

methodsPROs administered were the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and the PRO-Common Terminology Criteria for Adverse Events (CTCAE) items for diarrhea frequency and injection site reactions (for fulvestrant recipients only). Mean changes from baseline in EORTC QLQ-C30 scores were calculated using a longitudinal mixed model for repeated measures; a 10-point change defined as clinically meaningful. PRO-CTCAE analyses were descriptive. Interview transcripts were analyzed using directed content analysis techniques.

resultsOverall, global health status/quality of life (GHS/QoL) and function were generally maintained over time across treatment arms among the ESR1m population and all patients, with treatment differences favoring imlunestrant versus SOC among the ESR1m population. Fewer GHS/QoL and function deterioration events occurred in the imlunestrant arm (ESR1m and all patients) compared with other treatment arms. Most (72.3%) fulvestrant-treated patients reported injection site reactions at any time. Diarrhea frequency was consistently higher in the combination arm of imlunestrant-abemaciclib.

conclusionGHS/QoL and function were maintained across treatment arms, despite a higher incidence of diarrhea in the imlunestrant-abemaciclib group. These PRO findings complement the efficacy and safety results from EMBER-3 and further support the favorable risk-benefit profile of imlunestrant, either as oral monotherapy or in combination with abemaciclib, in patients with advanced breast cancer.

Indexed as

Breast NeoplasmsPatient Reported Outcome MeasuresAdultAgedErb-b2 Receptor Tyrosine KinasesEstrogen Receptor alphaFemaleHumansMiddle AgedQuality of LifeReceptors, EstrogenERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesEstrogen Receptor alphaReceptors, Estrogenadvanced breast cancerESR1 mutationsimlunestrantoral selective estrogen receptor degraders (SERDs)patient-reported outcomesquality of life

Identifiers

PMID41962306
PMCPMC13091516

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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.