Evidence map›Paper›PMID 38381994›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative,

Mirat Shah, Hima Lingam, Xin Gao, Haley Gittleman, Mallorie H Fiero, Danielle Krol, Nikolett Biel, Tiffany K Ricks, Wentao Fu, Salaheldin Hamed and 18 more

Open access · greenAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
13.0field-weighted citation impact, top 1% of its field
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

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Imlunestrant with or without abemaciclib in advanced breast cancer: updated efficacy results from the phase III EMBER-3 trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
    Trial
  5. Article
  6. Review
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  10. Article
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  12. Article
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  15. ESR1 fusions in breast cancer: functions, mechanisms and therapeutic opportunities.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
    Review
  16. Exploration of targeted anti-tumor therapy · 2026
    Review
  17. Review
  18. Article
  19. Therapeutic Potential of Metal-Based and PARP Inhibitor Chemotherapy forInternational journal of molecular sciences · 2025
    Review
  20. 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

28 authors at 1 institution in 1 country.

Mirat ShahCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0003-0052-9978
Hima LingamCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0009-0003-6214-7921
Xin GaoCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-7383-6453
Haley GittlemanCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-6976-8777
Mallorie H FieroCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Danielle KrolCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-2172-9680
Nikolett BielCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Tiffany K RicksCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Wentao FuCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Salaheldin HamedCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Fang LiCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Jillian Jielin SunCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Jianghong FanCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Robert SchuckCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-5855-1361
Manuela GrimsteinCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-6430-3022
Liuya TangCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.
Shyam KalavarCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.
Abdelrahmman AbukhdeirCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.
Anand PathakCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.
Soma GhoshCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.
Ilynn BulataoOncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-4706-0372
Amy TilleyCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
William F PierceOncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-3411-7720
Bronwyn D MixterOncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0001-5277-4399
Shenghui TangCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-0437-665X
Richard PazdurCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-4771-9923
Paul KluetzCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Laleh Amiri-KordestaniCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-0056-5437
United States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe US Food and Drug Administration (FDA) approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 ( PATIENTS AND

methodsApproval was based on EMERALD (Study RAD1901-308), a randomized, open-label, active-controlled, multicenter trial in 478 patients with ER+, HER2- advanced or metastatic breast cancer, including 228 patients with

resultsIn the

conclusionThe approval of elacestrant in ER+, HER2- advanced or metastatic breast cancer was restricted to patients with

Indexed as

Breast NeoplasmsTetrahydronaphthalenesAdultAntineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesEstrogen Receptor alphaFemaleHumansUnited StatesUnited States Food and Drug AdministrationelacestrantERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesEstrogen Receptor alphaTetrahydronaphthalenes

Identifiers

PMID38381994
PMCPMC11003513
OpenAlexW4392015946

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.