Gene
ERBB2
ERBB2 is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (35), Assay-provider ledger (658), Actionable biomarkers (82), and 8 more evidence types, each linked to its source.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Rows recorded per section (log scale)
3 more sections with rows · 1 section measured, none recorded
FDA companion diagnostic
An FDA-cleared or approved companion diagnostic names this biomarker.
Evidence over time
Share of that year: what fraction of the trials and papers our biomarker dictionary matched in a year mention ERBB2. 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: 16 with a planned future start and 24 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 5 dated before 1990 and 530 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 604 of 8,738 | 6.91% | not measured | |
| 2025 | 587 of 8,875 | 6.61% | not measured | |
| 2024 | 547 of 8,597 | 6.36% | not measured | |
| 2023 | 538 of 8,275 | 6.50% | 535 of 11,460 | 4.67% |
| 2022 | 472 of 8,285 | 5.70% | 505 of 13,598 | 3.71% |
| 2021 | 458 of 8,692 | 5.27% | 589 of 15,045 | 3.91% |
| 2020 | 391 of 7,640 | 5.12% | 522 of 14,459 | 3.61% |
| 2019 | 352 of 7,300 | 4.82% | 424 of 12,159 | 3.49% |
| 2018 | 285 of 6,927 | 4.11% | 376 of 11,854 | 3.17% |
| 2017 | 291 of 6,558 | 4.44% | 373 of 11,595 | 3.22% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (35)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| Guardant360 CDx | ERBB2 | Guardant Health, Inc. | Non-small cell lung cancer (NSCLC) | 2026-06-10 |
| Guardant360 CDx | HER2 | Guardant Health, Inc. | Non-small cell lung cancer (NSCLC) | 2026-06-10 |
| Guardant360® Liquid CDx | ERBB2 | Guardant Health, Inc. | Non-small cell lung cancer (NSCLC) | 2026-05-19 |
| Guardant360® Liquid CDx | HER2 | Guardant Health, Inc. | Non-small cell lung cancer (NSCLC) | 2026-05-19 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail | ERBB2 (HER2) | Ventana Medical Systems, Inc. | Breast Cancer | 2026-05-15 |
Showing 5 of 35 companion diagnostic entries.
Assay-provider ledger (658)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| Boston Cell Standards | Unclassified | Clinical validationAnalytical validation | 5 | August 01, 2026 |
| Visiopharm | Unclassified | Clinical validationAnalytical validation | 10 | August 01, 2026 +1 undated |
| Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Navi Mumbai, Maharashtra, India | Not a company | Clinical validation | 1 | July 17, 2026 |
| Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India | Not a company | Clinical validation | 1 | July 17, 2026 |
| Chengdu Zhongying Medical Technology Co., Ltd. | Context dependent | Clinical validation | 1 | July 01, 2026 |
Showing 5 of 658 assay-provider companies.
Actionable biomarkers (82)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| ERBB2 amplification | PERTUZUMAB | response-associated | biliary tract neoplasm | Cancer Genome Interpreter |
| ERBB2 amplification | TRASTUZUMAB | response-associated | biliary tract neoplasm | Cancer Genome Interpreter |
| ERBB2 amplification | LAPATINIB | response-associated | biliary tract neoplasm | Cancer Genome Interpreter |
| ERBB2 (D769Y,D769H,R896C,V777L,V842I,G309A) | LAPATINIB | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| ERBB2 expression + ESR1 overexpression | Exemestane | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
Showing 5 of 82 actionable-biomarker assertions.
Trial mentions (6,720)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT07597369 | Trial biospecimen (AACT) |
| NCT06952400 | Trial biospecimen (AACT) |
| NCT07404202 | Trial biospecimen (AACT) |
| NCT02773784 | Trial biospecimen (AACT) |
| NCT03872440 | Trial biospecimen (AACT) |
Showing 5 of 6,720 trial mentions.
Target-disease associations (1,048)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| AIDS dementia | infectious disease | Literature (Europe PMC) |
| ATTRV122I amyloidosis | cardiovascular disease | Mouse knockout (IMPC) |
| Acute Leukemia | cancer or benign tumor | Literature (Europe PMC) |
| Adenoid Cystic Breast Carcinoma | cancer or benign tumor | Cancer Gene Census |
| Adenosquamous Carcinoma | cancer or benign tumor | Literature (Europe PMC) |
Showing 5 of 1,048 associations.
Vendor sourcing (21,508)
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 | : 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 | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Male or female. Age: 18-75 years. 2. Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advan... | View trial NCT02004769 |
| 307th Hospital of Chinese People’s Liberation Army | Trial collaborator | Named in trial inclusion criteriaTrial eligibility criteria | : * Signed informed consent * The age is Above 18 years of age, \<70 years old * HR-positive \& HER2-negative * Metastatic breast cancer,incurable. * No pri... | View trial NCT02597868 |
| 307th Hospital of Chinese People’s Liberation Army | Trial collaborator | Mentioned in trial textTrial free-text mention | HER2 | View trial NCT02004769 |
| 307th Hospital of Chinese People’s Liberation Army | Trial collaborator | Mentioned in trial textTrial free-text mention | HER2 | View trial NCT01287624 |
Showing 5 of 21,508 sourcing records.
Trial-cited literature (6,208)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Overall survival with abemaciclib in early breast cancer. | Annals of oncology : official journal of the European Society for Medical Oncology | 2026 | 41 |
| Palbociclib for Hormone-Receptor-Positive, HER2-Positive Advanced Breast Cancer. | The New England journal of medicine | 2026 | 19 |
| Intraperitoneal and intravenous paclitaxel plus S-1 and sintilimab as first-line treatment for gastric cancer with peritoneal metastasis: a single-arm phase 2 trial (DRAGON-09). | EClinicalMedicine | 2026 | 8 |
| TRADE: a phase II trial to assess the tolerability of abemaciclib dose escalation in early-stage HR-positive/HER2-negative breast cancer. | Annals of oncology : official journal of the European Society for Medical Oncology | 2026 | 8 |
| Neoadjuvant Taxane Plus Trastuzumab and Pertuzumab With or Without Carboplatin in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The Randomized Noninferiority Phase III neoCARHP Trial. | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 2026 | 5 |
Showing 5 of 6,208 papers.
Protein variant mentions (97)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A1081S | 1 | 2015 | PMID 26452060 |
| p.A166R | 1 | 2023 | PMID 36357174 |
| p.A201N | 1 | 2016 | PMID 27713176 |
| p.A300K | 1 | 2021 | PMID 33761970 |
| p.A4S | 1 | 2018 | PMID 30107082 |
Showing 5 of 97 variants.
Human sample screening reference (11)
Shown in this order: alphabetical by variant.
| Variant | GDC project | Disease / site | Affected cases | Profiled cases | Observed frequency | 95% interval |
|---|---|---|---|---|---|---|
| p.D277Y | ALCHEMIST-ALCH | Not Reported; Not Reported | 1 | 1,170 | 0.09% | 0.02% to 0.48% |
| p.D277Y | TCGA-BLCA | Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Squamous Cell Neoplasms; Transitional Cell Papillomas and Carcinomas; Bladder | 1 | 412 | 0.24% | 0.04% to 1.36% |
| p.E1079K | TCGA-CESC | Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Complex Epithelial Neoplasms; Squamous Cell Neoplasms; Ovary; Cervix uteri | 1 | 306 | 0.33% | 0.06% to 1.83% |
| p.H878Y | HCMI-CMDC | Ductal and Lobular Neoplasms; Complex Mixed and Stromal Neoplasms; Blood Vessel Tumors; Fibromatous Neoplasms; Epithelial Neoplasms, NOS; Mature T- and NK-Cell Lymphomas; Transitional Cell Papillomas and Carcinomas; Complex Epithelial Neoplasms; Squamous Cell Neoplasms; Soft Tissue Tumors and Sarcomas, NOS; Lymphoid Leukemias; Cystic, Mucinous and Serous Neoplasms; Gliomas; Myomatous Neoplasms; Neuroepitheliomatous Neoplasms; Malignant Lymphomas, NOS or Diffuse; Acinar Cell Neoplasms; Osseous and Chondromatous Neoplasms; Synovial-like Neoplasms; Miscellaneous Bone Tumors; Nevi and Melanomas; Adenomas and Adenocarcinomas; Other and unspecified parts of tongue; Stomach; Bronchus and lung; Larynx; Uterus, NOS; Kidney; Esophagus; Other and ill-defined sites; Skin; Colon; Thyroid gland; Bladder; Adrenal gland; Eye and adnexa; Gallbladder; Connective, subcutaneous and other soft tissues; Rectosigmoid junction; Breast; Pancreas; Small intestine; Corpus uteri; Other and unspecified parts of mouth; Liver and intrahepatic bile ducts; Nasal cavity and middle ear; Hematopoietic and reticuloendothelial systems; Brain; Other and unspecified parts of biliary tract; Bones, joints and articular cartilage of other and unspecified sites; Rectum; Unknown; Lymph nodes; Ovary | 1 | 606 | 0.17% | 0.03% to 0.93% |
| p.I767M | TCGA-BLCA | Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Squamous Cell Neoplasms; Transitional Cell Papillomas and Carcinomas; Bladder | 2 | 412 | 0.49% | 0.13% to 1.75% |
Showing 5 of 11 cohort observations.
Literature-extracted relations (3,946)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| CARBOPLATIN | Chemical | negative_correlate |
Neoadjuvant Taxane Plus Trastuzumab and Pertuzumab With or Without Carboplatin in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The Randomized Noninferiority Phase III neoCARHP Trial. | 2026 |
| TRASTUZUMAB | Chemical | associate |
Trastuzumab Deruxtecan in Patients With HER2-Overexpressing NSCLC: Results From Part 1 of the Open-Label, Multicenter, Phase 1b DESTINY-Lung03 Trial. | 2025 |
| Ado Trastuzumab Emtansine | Chemical | negative_correlate |
Trastuzumab Deruxtecan in Residual HER2-Positive Early Breast Cancer. | 2025 |
| TRASTUZUMAB | Chemical | negative_correlate |
Tucatinib, trastuzumab, and capecitabine with stereotactic radiosurgery in patients with brain metastases from HER-2 positive breast cancer (TUTOR): Study protocol for a multicenter phase 1 clinical trial. | 2025 |
| Ado Trastuzumab Emtansine | Chemical | negative_correlate |
Tucatinib and trastuzumab emtansine for patients with previously treated HER2-positive locally advanced and metastatic breast cancer: primary analysis of the randomized phase III trial HER2CLIMB-02. | 2025 |
Showing 5 of 3,946 relation assertions.
Organizations publishing (1,710)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Dana-Farber Cancer Institute | Other | 381 | 2001 to 2026 |
| Memorial Sloan Kettering Cancer Center | Hospital | 367 | 1996 to 2026 |
| The University of Texas System | Academic | 297 | 2002 to 2026 |
| Mayo Clinic | Hospital | 226 | 2008 to 2026 |
| Harvard Medical School | Academic | 218 | 2002 to 2026 |
Showing 5 of 1,710 organizations.
Where ERBB2 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
- nervous system disease
- nutritional or metabolic disease
- phenotype
- pregnancy or perinatal disease
- reproductive system or breast disease
- respiratory or thoracic disease
- urinary system disease
821 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.