Evidence map›Paper›PMID 32466779›Full record

Observational studyBreast cancer research : BCR2020

Risk of early progression according to circulating ESR1 mutation, CA-15.3 and cfDNA increases under first-line anti-aromatase treatment in metastatic breast cancer.

Florian Clatot, Anne Perdrix, Ludivine Beaussire, Justine Lequesne, Christelle Lévy, George Emile, Michael Bubenheim, Sigrid Lacaille, Céline Calbrix, Laetitia Augusto and 9 more

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in Breast cancer research : BCR, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02473120 (Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 10% 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.

NCT02473120 nacompletednot on this map

Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer

TypeinterventionalSponsorCentre Henri BecquerelRan2015 to 2019Enrolled104ConditionsMetastatic Breast CancerArmsDetermination of ESR1 mutations
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Enhanced efficacy of a next-generation EEEV self-replicating RNA platform for combination cancer immunotherapies.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Serial analysis ofFrontiers in oncology · 2025
    Article
  11. Clinical Value of Liquid Biopsy in Patients with FGFR2 Fusion-Positive Cholangiocarcinoma During Targeted Therapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
  12. Observational
  13. Review
  14. Review
  15. Cancers · 2023
    Review
  16. Article
  17. Article
  18. Combinatorial Power of cfDNA, CTCs and EVs in Oncology.Diagnostics (Basel, Switzerland) · 2022
    Review
  19. 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

19 authors at 5 institutions in 1 country.

Florian ClatotDepartment of Medical Oncology, Centre Henri Becquerel, Rouen, France. florian.clatot@chb.unicancer.fr.ORCID 0000-0002-7074-9282
Anne PerdrixNormandie Univ, UNIROUEN, Inserm U1245, IRON group, Rouen University Hospital, Normandy Centre for Genomic and Personalized Medicine, Rouen, France.
Ludivine BeaussireNormandie Univ, UNIROUEN, Inserm U1245, IRON group, Rouen University Hospital, Normandy Centre for Genomic and Personalized Medicine, Rouen, France.
Justine LequesneClinical Research Unit, Centre Henri Becquerel, Rouen, France.
Christelle LévyInstitut Normand du Sein, Centre François Baclesse, Caen, France.
George EmileInstitut Normand du Sein, Centre François Baclesse, Caen, France.
Michael BubenheimDepartment of Clinical Research and Innovation, Rouen University Hospital, Rouen, France.
Sigrid LacailleNormandie Univ, UNIROUEN, Inserm U1245, IRON group, Rouen University Hospital, Normandy Centre for Genomic and Personalized Medicine, Rouen, France.
Céline CalbrixDepartment of Biopathology, Centre Henri Becquerel, Rouen, France.
Laetitia AugustoDepartment of Medical Oncology, Centre Henri Becquerel, Rouen, France.
Cécile GuillemetDepartment of Medical Oncology, Centre Henri Becquerel, Rouen, France.
Cristina AlexandruDepartment of Medical Oncology, Centre Henri Becquerel, Rouen, France.
Maxime FontanillesDepartment of Medical Oncology, Centre Henri Becquerel, Rouen, France.
David SefriouiNormandie Univ, UNIROUEN, Inserm U1245, IRON group, Rouen University Hospital, Normandy Centre for Genomic and Personalized Medicine, Rouen, France.
Lucie BurelClinical Research Unit, Centre Henri Becquerel, Rouen, France.
Sabine GuénotClinical Research Unit, Centre Henri Becquerel, Rouen, France.
Doriane RichardClinical Research Unit, Centre Henri Becquerel, Rouen, France.
Nasrin Sarafan-VasseurNormandie Univ, UNIROUEN, Inserm U1245, IRON group, Rouen University Hospital, Normandy Centre for Genomic and Personalized Medicine, Rouen, France.
Frédéric Di FioreDepartment of Medical Oncology, Centre Henri Becquerel, Rouen, France.
Inserm · FRCentre Henri BecquerelCentre Virchow-Villermé · FRCentre François Baclesse · FRUniversité de Rouen Normandie · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEndocrine therapy is recommended as a first-line treatment for hormone receptor-positive metastatic breast cancer (HR+MBC) patients. No biomarker has been validated to predict tumor progression in that setting. We aimed to prospectively compare the risk of early progression according to circulating ESR1 mutations, CA-15.3, and circulating cell-free DNA in MBC patients treated with a first-line aromatase inhibitor (AI).

methodsPatients with MBC treated with a first-line AI were prospectively included. Circulating biomarker assessment was performed every 3 months. The primary objective was to determine the risk of progression or death at the next follow-up visit (after 3 months) in case of circulating ESR1 mutation detection among patients treated with a first-line AI for HR+MBC.

resultsOverall, 103 patients were included, and 70 (68%) had progressive disease (PD). Circulating ESR1 mutations were detected in 22/70 patients with PD and in 0/33 patients without progression (p < 0.001). Among the ESR1-mutated patients, 18/22 had a detectable mutation prior to progression, with a median delay of 110 days from first detection to PD. The detection of circulating ESR1 mutations was associated with a 4.9-fold (95% CI 3.0-8.0) increase in the risk of PD at 3 months. Using a threshold value of 25% or 100%, a CA-15.3 increase was also correlated with progression (p < 0.001 and p = 0.003, respectively). In contrast to ESR1, the CA-15.3 increase occurred concomitantly with PD in most cases, in 27/47 (57%) with a 25% threshold and in 21/25 (84%) with a 100% threshold. Using a threshold value of either 25% or 100%, cfDNA increase was not correlated with progression.

conclusionThe emergence of circulating ESR1 mutations is associated with a 4.9-fold increase in the risk of early PD during AI treatment in HR+MBC. Our results also highlighted that tracking circulating ESR1 mutations is more relevant than tracking CA-15.3 or cfDNA increase to predict progression in this setting.

trial registrationClinicalTrials.gov, NCT02473120. Registered 16 June 2015-retrospectively registered after one inclusion (first inclusion 1 June 2015).

Indexed as

MutationAdultAgedAged, 80 and overAromatase InhibitorsBiomarkers, TumorBreast NeoplasmsCirculating Tumor DNACohort StudiesDisease ProgressionDrug Resistance, NeoplasmEstrogen Receptor alphaFemaleFollow-Up StudiesHumansMiddle AgedAromatase InhibitorsBiomarkers, TumorCirculating Tumor DNAESR1 protein, humanEstrogen Receptor alphaMucin-1Aromatase inhibitorBreast cancerCA-15.3Cell-free DNACirculating DNAESR1 mutation

Identifiers

PMID32466779
PMCPMC7254698
OpenAlexW3031745106

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.