Evidence map›Paper›PMID 37348019›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

AMEERA-3: Randomized Phase II Study of Amcenestrant (Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Monotherapy in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer.

Sara M Tolaney, Arlene Chan, Katarina Petrakova, Suzette Delaloge, Mario Campone, Hiroji Iwata, Parvin F Peddi, Peter A Kaufman, Elisabeth De Kermadec, Qianying Liu and 6 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04059484 (An Open Label Randomized Phase 2 Trial of Amcenestrant), which is not on this map. Cited by 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 3 pooled it
17.6field-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.

NCT04059484 phase2terminatednot on this map

An Open Label Randomized Phase 2 Trial of Amcenestrant (SAR439859), Versus Endocrine Monotherapy as Per Physician's Choice in Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies

TypeinterventionalSponsorSanofiRan2019 to 2025Enrolled367ConditionsBreast Cancer MetastaticArmsAmcenestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
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  8. US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative,Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  9. Article
  10. Targeting Estrogen Receptor for Breast Cancer.Current issues in molecular biology · 2026
    Review
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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

16 authors at 2 institutions in 11 countries.

Sara M TolaneyDana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-5940-8671
Arlene ChanCurtin University, Perth, Australia.ORCID 0000-0003-2135-2286
Katarina PetrakovaMasaryk Memorial Cancer Institute, Brno, Czech Republic.
Suzette DelalogeInstitut Gustave Roussy, Villejuif, France.ORCID 0000-0003-2106-9165
Mario CamponeInstitut de Cancérologie de l'Ouest, René Gauducheau, Saint-Herblain, France.
Hiroji IwataAichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0002-0242-4718
Parvin F PeddiProvidence Saint John's Cancer Institute, Santa Monica, CA.ORCID 0000-0002-8459-9828
Peter A KaufmanUniversity of Vermont Larner College of Medicine, Burlington, VT.ORCID 0000-0003-3677-6807
Elisabeth De KermadecSanofi, Cambridge, MA.
Qianying LiuSanofi, Cambridge, MA.
Patrick CohenSanofi, Vitry-sur-Seine, France.ORCID 0009-0008-1187-1123
Gautier PauxSanofi, Cambridge, MA.ORCID 0000-0003-3002-6351
Lei WangSanofi, Cambridge, MA.
Nils TernèsSanofi, Chilly-Mazarin, France.
Eric BoitierSanofi, Chilly-Mazarin, France.
Seock-Ah ImSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea.ORCID 0000-0002-5396-6533
Roche (Switzerland) · CHUniversity of Vermont · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAmcenestrant (oral selective estrogen receptor degrader) demonstrated promising safety and efficacy in earlier clinical studies for endocrine-resistant, estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer (aBC). PATIENTS AND

methodsIn AMEERA-3 (ClinicalTrials.gov identifier: NCT04059484), an open-label, worldwide phase II trial, patients with ER+/HER2- aBC who progressed in the (neo)adjuvant or advanced settings after not more than two previous lines of endocrine therapy (ET) were randomly assigned 1:1 to amcenestrant or single-agent endocrine treatment of physician's choice (TPC), stratified by the presence/absence of visceral metastases, previous/no treatment with cyclin-dependent kinase 4/6 inhibitor, and Eastern Cooperative Oncology Group performance status (0/1). The primary end point was progression-free survival (PFS) by independent central review, compared using a stratified log-rank test (one-sided type I error rate of 2.5%).

resultsBetween October 22, 2019, and February 15, 2021, 290 patients were randomly assigned to amcenestrant (n = 143) or TPC (n = 147). PFS was numerically similar between amcenestrant and TPC (median PFS [mPFS], 3.6

conclusionAMEERA-3 did not meet its primary objective of improved PFS with amcenestrant versus TPC although a numerical improvement in PFS was observed in patients with baseline

Indexed as

Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesFemaleHumansReceptors, EstrogenERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, Estrogen

Identifiers

PMID37348019
PMCPMC10461947
OpenAlexW4381612716

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.