ArticleESMO open2023
Retrospective study to estimate the prevalence and describe the clinicopathological characteristics, treatments received, and outcomes of HER2-low breast cancer.
Article in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04807595 (A Multicenter Study to Estimate the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2-low Status - the RetroBC-HER2L Study), which is not on this map. Cited by 58 papers.
What it found
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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.
A Multicenter Study to Estimate the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2-low Status - the RetroBC-HER2L Study
Who cites it
58 citing papers in PubMed.
- Trial
- Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial.Nature medicine · 2025Trial
- Trastuzumab deruxtecan versus treatment of physician's choice in previously treated Asian patients with HER2-low unresectable/metastatic breast cancer: subgroup analysis of the DESTINY-Breast04 study.Breast cancer (Tokyo, Japan) · 2024Trial
- Real-world treatment patterns and outcomes in hormone receptor-positive, HER2-low metastatic breast cancer, 2018-2023: a retrospective, observational, US cohort study.Breast cancer research and treatment · 2026Observational
- Clinical implications of discordance in HER2 reassessment from HercepTest to 4B5 in metastatic breast cancer.Breast cancer research and treatment · 2026Article
- Trastuzumab Deruxtecan for HER2-Low Metastatic Breast Cancer: Practical Considerations for Medical Oncologists and Pathologists in Australia.Asia-Pacific journal of clinical oncology · 2026Review
- Is the risk of brain metastasis and prognosis different in HER2-low breast cancer?Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Genome-wide biomarker analysis across the full spectrum of HER2-expressing breast cancers to reveal a clonal chromosome 17 imbalance defining unfavourable HER2-low disease.Biomarker research · 2026Article
- Elucidating the relationship between affinity and potency in the performance of therapeutic IgE.Scientific reports · 2026Article
- Mechanisms of Resistance and Synergy: The Role of Tumor Microenvironment in HER2-Low Breast Cancer Therapy.Pharmaceuticals (Basel, Switzerland) · 2026Review
- AI-enhanced precision: boosting pathologist confidence in HER2 ultra-low diagnosis through intelligent re-screening.Breast cancer research : BCR · 2026Article
- A SHAP-interpretable XGBoost model: MRI-based intratumoral perfusion heterogeneity predicts HER2-zero, -low, and -positive ternary expression status in breast cancer.Cancer imaging : the official publication of the International Cancer Imaging Society · 2026Article
- Molecular characteristics and advances in precision therapeutics for HR-positive and HER2-low breast cancer.Frontiers in oncology · 2026Review
- Prognostic value of RecurIndex in differentiating HER2-low from HER2-negative early-stage breast cancer: a comprehensive clinicopathologic and molecular analysis in Chinese patients.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026Article
- Multiparametric MRI-based nomogram integrating clinicopathological factors for predicting HER2 expression status in breast cancer.Frontiers in oncology · 2026Article
- Applications and challenges of utilizing digital pathology and AI-enabled workflows in clinical trials.Journal of pathology informatics · 2026Review
- HER2-Low and HER2-Ultralow Metastatic Breast Cancer and Trastuzumab Deruxtecan: Common Clinical Questions and Answers.Cancers · 2025Review
- Automated machine learning-based unenhanced radiomics for identification of HER2-low breast cancers using diffusion-weighted imaging.BMC cancer · 2025Article
- Standardizing the pathologic assessment of HER2-(ultra)low breast cancer: insights from a national Italian project.Pathologica · 2025Article
- Bibliometric analysis of global research on breast cancer with HER2-low expression.Discover oncology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundApproximately 80% of all breast cancers (BCs) are currently categorized as human epidermal growth factor receptor 2 (HER2)-negative [immunohistochemistry (IHC) 0, 1+, or 2+/in situ hybridization (ISH) negative]; approximately 60% of BCs traditionally categorized as HER2-negative express low levels of HER2. HER2-low (IHC 1+ or IHC 2+/ISH-) status became clinically actionable with approval of trastuzumab deruxtecan to treat unresectable/metastatic HER2-low BC. Greater understanding of patients with HER2-low disease is urgently needed. PATIENTS AND
methodsThis global, multicenter, retrospective study (NCT04807595) included tissue samples from patients with confirmed HER2-negative unresectable/metastatic BC [any hormone receptor (HR) status] diagnosed from 2014 to 2017. Pathologists rescored HER2 IHC-stained slides as HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 IHC 0 after training on low-end expression scoring using Ventana 4B5 and other assays at local laboratories (13 sites; 10 countries) blinded to historical scores. HER2-low prevalence and concordance between historical scores and rescores were assessed. Demographics, clinicopathological characteristics, treatments, and outcomes were examined.
resultsIn rescored samples from 789 patients with HER2-negative unresectable/metastatic BC, the overall HER2-low prevalence was 67.2% (HR positive, 71.1%; HR negative, 52.8%). Concordance was moderate between historical and rescored HER2 statuses (81.3%; κ = 0.583); positive agreement was numerically higher for HER2-low (87.5%) than HER2 IHC 0 (69.9%). More than 30% of historical IHC 0 cases were rescored as HER2-low overall (all assays) and using Ventana 4B5. There were no notable differences between HER2-low and HER2 IHC 0 in patient characteristics, treatments received, or clinical outcomes.
conclusionsApproximately two-thirds of patients with historically HER2-negative unresectable/metastatic BC may benefit from HER2-low-directed treatments. Our data suggest that HER2 reassessment in patients with historical IHC 0 scores may be considered to help optimize selection of patients for treatment. Further, accurate identification of patients with HER2-low BC may be achieved with standardized pathologist training.
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