Evidence map›Paper›PMID 42045295›Full record

ArticleNPJ breast cancer2026

Imlunestrant with or without abemaciclib in advanced breast cancer: safety analyses from the EMBER-3 trial.

Joyce O'Shaughnessy, Francois-Clement Bidard, Patrick Neven, Monica Lis Casalnuovo, Philippe Aftimos, Cristina Saura, Nadia Harbeck, Lisa A Carey, Giuseppe Curigliano, Jose A Garcia-Saenz and 9 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ breast cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04975308 (EMBER-3), which is not on this 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.

NCT04975308 phase3active not recruitingnot on this map

EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

TypeinterventionalSponsorEli Lilly and CompanyRan2021 to 2027Enrolled874ConditionsBreast Neoplasms, Neoplasm MetastasisArmsImlunestrant, Exemestane, Fulvestrant, Abemaciclib
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

19 authors.

Joyce O'ShaughnessyBaylor University Medical Center, Texas Oncology, Sarah Cannon Research Institute, Dallas, TX, USA. Joyce.OShaughnessy@USONCOLOGY.COM.
Francois-Clement BidardInstitut Curie, Paris and Saint Cloud, Saint Cloud, France.
Patrick NevenDepartment of Oncology, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.
Monica Lis CasalnuovoHospital María Curie, Buenos Aires, Argentina.
Philippe AftimosInstitut Jules Bordet, Hôpital Universitaire de Bruxelles (HUB), Brussels, Belgium.
Cristina SauraVall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Nadia HarbeckBreast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany.
Lisa A CareyUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Giuseppe CuriglianoDepartment of Oncology and Hemato-Oncology, University of Milano, Milano, Italy.
Jose A Garcia-SaenzHospital Clinico Universitario San Carlos, Madrid, Spain.
Maria Fernandez AbadHospital Universitario Ramón y Cajal, Madrid, Spain.
Larissa de PaulaNúcleo de Pesquisa do Instituto Brasileiro de Controle do Câncer (IBCC Oncologia), São Paulo, Brazil.
Yeon Hee ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Ozgur OzyilkanBaskent University, Adana, Turkey.
Maria MunozEli Lilly and Company, Indianapolis, IN, USA.
Emily BarrettEli Lilly and Company, Indianapolis, IN, USA.
Shanshan CaoEli Lilly and Company, Indianapolis, IN, USA.
Aarti ChawlaEli Lilly and Company, Indianapolis, IN, USA.
Komal L JhaveriMemorial Sloan Kettering Cancer Center, New York, NY, USA.

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

In EMBER-3 (NCT04975308), among patients with ER + , HER2- advanced breast cancer (ABC) with recurrence/progression on/after endocrine therapy (ET), imlunestrant significantly prolonged PFS versus standard ET in patients with ESR1 mutations, and imlunestrant + abemaciclib prolonged PFS versus imlunestrant in the overall population. We report the incidence, severity, timing, and management of common treatment-emergent adverse events (TEAEs), including safety profiles of select subgroups. In both imlunestrant-containing arms, the most common TEAEs were reversible, low grade, single occurrences; occurred early in treatment; and resulted in few treatment discontinuations (imlunestrant, 5%; imlunestrant + abemaciclib, 6%). TEAEs in imlunestrant+abemaciclib arm were managed with dose adjustments (61%) and supportive medication. Imlunestrant monotherapy had a similar safety profile between patients aged <65 and ≥65 years, while imlunestrant + abemaciclib had a similar safety profile to other abemaciclib+ET combinations in both age groups. Imlunestrant and imlunestrant + abemaciclib provide effective, convenient oral therapy with a favorable and manageable safety profile for patients with ER+, HER2- ABC with recurrence/progression on/after ET.

Identifiers

PMID42045295
PMCPMC13324159

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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 OpenQuestion graph.