Evidence map›Paper›PMID 42709321›Full record

ArticleMolecular diagnosis & therapy2026

Bridging Biomarker Testing to Biomarker-Driven Targeted Therapy: Real-World ESR1 Mutation Testing Patterns and Prevalence in ER+, HER2- Metastatic Breast Cancer.

Chi-Yin Liao, Jincy John, Precious Anyanwu, Manali A Bhave, Francois-Clement Bidard, Tyler Marquart, Francisco Sapunar, Aarti Chawla, Lindsay A Williams

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Article in Molecular diagnosis & therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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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

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4 · The record

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5 · Who and what money

Authors and funding

9 authors.

Chi-Yin LiaoEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Jincy JohnEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Precious AnyanwuEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Manali A BhaveWinship Cancer Institute of Emory University, Atlanta, GA, USA.
Francois-Clement BidardInstitut Curie, Paris, France.
Tyler MarquartEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Francisco SapunarEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Aarti ChawlaEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Lindsay A WilliamsEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. lindsay.williams@lilly.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) treatment landscape continues to evolve with targeted therapy development. Estrogen receptor 1 (ESR1) testing is recommended at recurrence or each progression event to identify patients for effective therapies. However, there is limited information on testing and mutation patterns in the real world that can inform patient identification in the clinic.

methodsA retrospective observational study among patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative MBC who initiated first line (1L) therapy with aromatase inhibitors or selective estrogen receptor degraders ± CDK4/6 inhibitors from 1 January, 2020 to 31 March, 2025, using the Flatiron Health Research Database was conducted. ESR1 testing and mutation positivity rates at 1L to third line initiation, stratified by endocrine-resistant, 1L endocrine-sensitive, and endocrine-sensitive/de novo MBC were descriptively reported.

resultsOverall testing rates varied across subgroups, with one or more ESR1 test per patient in 61.2% of patients with endocrine-resistant MBC (n = 2152), 50.5% in patients with 1L endocrine-sensitive MBC (n = 827), and 43.1% in patients with endocrine-sensitive/de novo MBC (n = 5772). Testing rates at 1L initiation were 36.2% in endocrine-resistant MBC and 19.6% in endocrine-sensitive/de novo MBC. Testing rates were approximately 32% at second line and 25% at third line across subgroups. ESR1 mutation positivity (ESR1m+) rates varied by subgroup at 1L initiation and were highest among patients with endocrine-resistant MBC (24.7%), followed by patients with 1L endocrine-sensitive MBC (6.9%) and patients with endocrine-sensitive/de novo MBC (2.1%). All groups had ESR1m+ rates around 30% at second line initiation and 40% at third line initiation. In an exploratory analysis, ~ 60% of ESR1 tests during 1L were conducted in tissue and ~ 40% in blood.

conclusionsIn this population, real-world ESR1 testing rates were low. One in four patients with endocrine-resistant MBC were ESR1m+ at 1L initiation, ~ 30% were ESR1m+ at second line across subgroups, and ~ 40% were ESR1m+ at third line across subgroups. More blood-based testing at recurrence and progression is recommended in the real world to align with guideline recommendations as ESR1m detection is more sensitive in blood than in tissue.

Identifiers

PMID42709321

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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 Socratic graph.