Gene
ESR1
ESR1 is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (5), Assay-provider ledger (299), Actionable biomarkers (15), and 8 more evidence types, each linked to its source.
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Rows recorded per section (log scale)
3 more sections with rows · 1 section measured, none recorded
FDA companion diagnostic
Evidence over time
Share of that year: what fraction of the trials and papers our biomarker dictionary matched in a year mention ESR1. The denominator is documents that mention any gene, not every registered document, so improving the matcher moves both halves and never rewrites history. Gene named in free-text trial records. A mention, not a validated biomarker. Actionable-biomarker and target-disease-association evidence carries no date in our sources, so it is not on this chart. Publication mentions cover only papers cited by a registered clinical trial, not all of PubMed.
Trial mentions: plotted from 1990 to 2026, the years our matched corpus covers. Not plotted: 2 dated before 1990, 6 with a planned future start, and 7 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 14 dated before 1990 and 118 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 125 of 8,738 | 1.43% | not measured | |
| 2025 | 101 of 8,875 | 1.14% | not measured | |
| 2024 | 97 of 8,597 | 1.13% | not measured | |
| 2023 | 86 of 8,275 | 1.04% | 223 of 11,460 | 1.95% |
| 2022 | 103 of 8,285 | 1.24% | 262 of 13,598 | 1.93% |
| 2021 | 125 of 8,692 | 1.44% | 291 of 15,045 | 1.93% |
| 2020 | 113 of 7,640 | 1.48% | 246 of 14,459 | 1.70% |
| 2019 | 112 of 7,300 | 1.53% | 224 of 12,159 | 1.84% |
| 2018 | 90 of 6,927 | 1.30% | 212 of 11,854 | 1.79% |
| 2017 | 102 of 6,558 | 1.56% | 216 of 11,595 | 1.86% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (5)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| Guardant360® Liquid CDx | ESR1 | Guardant Health, Inc. | Breast Cancer | 2026-05-19 |
| Guardant360® Liquid CDx | ESR1 | Guardant Health, Inc. | Breast cancer | 2026-05-19 |
| Guardant360 CDx | ESR1 | Guardant Health, Inc. | Breast Cancer | 2026-05-01 |
| Guardant360 CDx | ESR1 | Guardant Health, Inc. | Breast Cancer | 2025-09-25 |
| Guardant360 CDx | ESR1 | Guardant Health, Inc. | Breast Cancer | 2023-01-27 |
Assay-provider ledger (299)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| AstraZeneca | Pharma or other | Analytical validation | 2 | May 02, 2026 |
| Bayer | Unclassified | Clinical validation | 2 | May 02, 2026 |
| Bracco | Pharma or other | Clinical validation | 2 | May 02, 2026 |
| Daiichi Sankyo | Pharma or other | No clinical or analytical validation recorded for this pair | 1 | May 02, 2026 |
| Editree srl | Unclassified | No clinical or analytical validation recorded for this pair | 1 | May 02, 2026 |
Showing 5 of 299 assay-provider companies.
Actionable biomarkers (15)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| ESR1-YAP1 fusion | Esr1 Inhibitors | responsive | breast adenocarcinoma | Cancer Genome Interpreter |
| ERBB2 expression + ESR1 overexpression | Abemaciclib | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| ERBB2 expression + ESR1 overexpression | Anastrozole | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| ERBB2 expression + ESR1 overexpression | Lhrh Analogues Or Antagonist | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| ESR1 (Y537S) | FULVESTRANT | responsive | breast adenocarcinoma | Cancer Genome Interpreter |
Showing 5 of 15 actionable-biomarker assertions.
Trial mentions (2,039)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT01233219 | Trial biospecimen (AACT) |
| NCT03786393 | Trial biospecimen (AACT) |
| NCT06331104 | Trial biospecimen (AACT) |
| NCT01233752 | Trial biospecimen (AACT) |
| NCT01944475 | Trial biospecimen (AACT) |
Showing 5 of 2,039 trial mentions.
Target-disease associations (1,599)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| 12q14 microdeletion syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 22q11.2 deletion syndrome | cardiovascular disease | Mouse knockout (IMPC) |
| 45,X/46,XY mixed gonadal dysgenesis | endocrine system disease | Mouse knockout (IMPC) |
| 46 XX gonadal dysgenesis | endocrine system disease | Mouse knockout (IMPC) |
| 46,XX disorder of sex development - skeletal anomalies | cancer or benign tumor | Mouse knockout (IMPC) |
Showing 5 of 1,599 associations.
Vendor sourcing (6,477)
Shown in this order: alphabetical by organization.
| Organization | Role | Tier | Evidence | Citation |
|---|---|---|---|---|
| 307th Hospital of Chinese People’s Liberation Army | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | : * Female patients, age ≦65 years * Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer * Must have completed a 4-cycle ne... | View trial NCT01019616 |
| 307th Hospital of Chinese People’s Liberation Army | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Females with age between 18 and 70 years old 2. Histological proven unresectable recurrent or advanced breast cancer 3. Triple-negative for estrogen re... | View trial NCT01287624 |
| 307th Hospital of Chinese People’s Liberation Army | Trial collaborator | Mentioned in trial textTrial free-text mention | Estrogen receptor | View trial NCT01019616 |
| 307th Hospital of Chinese People’s Liberation Army | Trial collaborator | Mentioned in trial textTrial free-text mention | Estrogen receptor | View trial NCT01287624 |
| A Glimmer of Hope Foundation | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Females, 18 years of age or older. Pre-menopausal women must use an effective method of contraception during the study. 2. Capable of providing informe... | View trial NCT06218303 |
Showing 5 of 6,477 sourcing records.
Trial-cited literature (3,532)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Fasting boosts breast cancer therapy efficacy via glucocorticoid activation. | Nature | 2026 | 9 |
| TBCRC 048 (Olaparib Expanded) Expansion Cohorts: Phase II Study of Olaparib Monotherapy for Patients With Metastatic Breast Cancer With Germline Mutations in <i>PALB2</i> or Somatic Mutations in <i>BRCA1</i> or <i>BRCA2</i>. | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 2026 | 3 |
| Evaluating progesterone receptor agonist megestrol plus letrozole for women with early-stage estrogen-receptor-positive breast cancer: the window-of-opportunity, randomized, phase 2b, PIONEER trial. | Nature cancer | 2026 | 1 |
| OPERA-01: a phase III study of palazestrant for ER+, HER2- advanced breast cancer after CDK4/6 inhibitor therapy. | Future oncology (London, England) | 2026 | 1 |
| Patient-reported outcomes from the randomized ALICE trial evaluating the addition of atezolizumab to anthracycline-based chemotherapy in metastatic triple-negative breast cancer. | Breast (Edinburgh, Scotland) | 2026 | 0 |
Showing 5 of 3,532 papers.
Protein variant mentions (38)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A125I | 1 | 2016 | PMID 26696461 |
| p.C381S | 1 | 2022 | PMID 35642432 |
| p.C417S | 1 | 2022 | PMID 35642432 |
| p.C530S | 1 | 2022 | PMID 35642432 |
| p.D351Y | 1 | 2014 | PMID 24398047 |
Showing 5 of 38 variants.
Human sample screening reference (10)
Shown in this order: alphabetical by variant.
| Variant | GDC project | Disease / site | Affected cases | Profiled cases | Observed frequency | 95% interval |
|---|---|---|---|---|---|---|
| p.D538G | CPTAC-3 | Not Applicable; Transitional Cell Papillomas and Carcinomas; Ductal and Lobular Neoplasms; Adenomas and Adenocarcinomas; Gliomas; Epithelial Neoplasms, NOS; Complex Epithelial Neoplasms; Complex Mixed and Stromal Neoplasms; Lipomatous Neoplasms; Squamous Cell Neoplasms; Myeloid Leukemias; Nevi and Melanomas; Stomach; Other and ill-defined sites in lip, oral cavity and pharynx; Unknown; Colon; Other and unspecified urinary organs; Floor of mouth; Other and unspecified parts of mouth; Gum; Bronchus and lung; Oropharynx; Other and unspecified parts of tongue; Base of tongue; Breast; Other and ill-defined sites; Larynx; Lip; Uterus, NOS; Hematopoietic and reticuloendothelial systems; Kidney; Brain; Skin; Pancreas; Tonsil | 1 | 1,815 | 0.06% | 0.01% to 0.31% |
| p.D538G | TCGA-UCEC | Not Reported; Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Corpus uteri; Uterus, NOS | 3 | 559 | 0.54% | 0.18% to 1.57% |
| p.L536P | CPTAC-3 | Not Applicable; Transitional Cell Papillomas and Carcinomas; Ductal and Lobular Neoplasms; Adenomas and Adenocarcinomas; Gliomas; Epithelial Neoplasms, NOS; Complex Epithelial Neoplasms; Complex Mixed and Stromal Neoplasms; Lipomatous Neoplasms; Squamous Cell Neoplasms; Myeloid Leukemias; Nevi and Melanomas; Stomach; Other and ill-defined sites in lip, oral cavity and pharynx; Unknown; Colon; Other and unspecified urinary organs; Floor of mouth; Other and unspecified parts of mouth; Gum; Bronchus and lung; Oropharynx; Other and unspecified parts of tongue; Base of tongue; Breast; Other and ill-defined sites; Larynx; Lip; Uterus, NOS; Hematopoietic and reticuloendothelial systems; Kidney; Brain; Skin; Pancreas; Tonsil | 2 | 1,815 | 0.11% | 0.03% to 0.40% |
| p.Y537C | TCGA-UCEC | Not Reported; Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Corpus uteri; Uterus, NOS | 1 | 559 | 0.18% | 0.03% to 1.01% |
| p.Y537N | CMI-MBC | Ductal and Lobular Neoplasms; Breast | 2 | 174 | 1.15% | 0.32% to 4.09% |
Showing 5 of 10 cohort observations.
Literature-extracted relations (1,084)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| MEGESTROL | Chemical | negative_correlate |
Evaluating progesterone receptor agonist megestrol plus letrozole for women with early-stage estrogen-receptor-positive breast cancer: the window-of-opportunity, randomized, phase 2b, PIONEER trial. | 2026 |
| FULVESTRANT | Chemical | negative_correlate |
Combination of Olaparib, Durvalumab, and Fulvestrant in Patients with Advanced ER+/HER2- Breast Cancer and Selected Genomic Alterations: Results of the DOLAF Trial. | 2025 |
| Letrozole | Chemical | negative_correlate |
Genomic alterations are associated with response to aromatase inhibitor therapy for ER-positive postmenopausal ductal carcinoma in situ: (CALGB 40903, Alliance). | 2025 |
| FULVESTRANT | Chemical | negative_correlate |
Estrogen receptor-α ablation reverses muscle fibrosis and inguinal hernias. | 2025 |
| Tamoxifen | Chemical | negative_correlate |
ESR1 and p53 interactome alteration defines mechanisms of tamoxifen response in luminal breast cancer. | 2024 |
Showing 5 of 1,084 relation assertions.
Organizations publishing (1,267)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Dana-Farber Cancer Institute | Other | 146 | 2009 to 2026 |
| Memorial Sloan Kettering Cancer Center | Hospital | 138 | 2001 to 2026 |
| Harvard Medical School | Academic | 120 | 2010 to 2026 |
| Mayo Clinic | Hospital | 115 | 2007 to 2025 |
| The University of Texas System | Academic | 114 | 1998 to 2025 |
Showing 5 of 1,267 organizations.
Where ESR1 appears
- animal disease
- biological_process
- cancer or benign tumor
- cardiovascular disease
- disorder of ear
- disorder of visual system
- endocrine system disease
- gastrointestinal disease
- genetic, familial or congenital disease
- hematologic disease
- immune system disease
- infectious disease
- injury, poisoning or other complication
- integumentary system disease
- measurement
- medical procedure
- musculoskeletal or connective tissue disease
- nervous system disease
- nutritional or metabolic disease
- phenotype
- pregnancy or perinatal disease
- psychiatric disorder
- reproductive system or breast disease
- respiratory or thoracic disease
- urinary system disease
1,397 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.