ArticleBreast cancer research : BCR2025
Prevalence and concordance of HER2-low and HER2-ultralow status between historical and rescored results in a multicentre study of breast cancer patients in China.
Article in Breast cancer research : BCR, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05203458 (HER2 Retrospective Epidemiology Study Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients), which is not on this map. Cited by 11 papers.
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.
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.
HER2 Retrospective Epidemiology Study Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients (HER2 PATH)
Who cites it
11 citing papers in PubMed.
- Revisiting HER2-negative breast cancer in the era of HER2-low and HER2-ultralow expression: Assessment of interobserver variability.Breast (Edinburgh, Scotland) · 2026Article
- Tumour-infiltrating lymphocytes differ across MammaPrint® classifications in breast cancer.Endocrine-related cancer · 2026Article
- Diagnostic reproducibility, spatial heterogeneity, and survival outcomes of HER2-Null, HER2-Ultralow, and HER2-Low categories in invasive breast carcinoma.Virchows Archiv : an international journal of pathology · 2026Article
- Molecular cartography of breast cancer: decoding genomes, heterogeneity and the tumor microenvironment for personalized targeted therapeutics.Molecular biology reports · 2026Review
- Redefining breast cancer: therapeutic opportunities in HER2-low and emerging molecular subtypes.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- Digital image analysis improves diagnostic accuracy of HER2-low and HER2-ultralow breast cancer: a step towards personalised medicine.Virchows Archiv : an international journal of pathology · 2026Article
- "HER2-Low" and the Challenge of Repurposing Legacy HER2 IHC Biomarker Assays.Current oncology (Toronto, Ont.) · 2026Article
- Prevalence of HER2-ultralow breast cancer in South Korea: a multicenter study by reassessment of HER2-zero cases.Journal of pathology and translational medicine · 2026Article
- Redefining HER2 in Breast Cancer: From Conventional Positivity to Low and Ultralow in the New Era of Antibody-Drug Conjugates.Cancer research and treatment · 2026Review
- Focal hotspot and diffuse immune subtypes of tumor-infiltrating lymphocytes: AI-powered spatial clustering classification and its clinical relevance to HER2 expression in triple-negative breast cancer.Journal of translational medicine · 2025Article
- Personalized prediction of breast cancer candidates for Anti-HER2 therapy usingFrontiers in 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
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAccurately assessing HER2-low (immunohistochemistry [IHC] 1 + and IHC 2+/in situ hybridization [ISH]-) and HER2-ultralow (IHC > 0 < 1+) is essential given the emergence of novel therapies. Thorough understanding of the reproducibility of rescoring IHC stained slides or re-staining archived tissue slides is essential.
methods2,869 breast cancer patients diagnosed between July 2021 and July 2022 from 10 hospitals in China were included in this multicentre study. The prevalence of different HER2 expression levels and distribution of HER2 IHC scores were assessed by HER2 status determination from rescored historical slides. Concordance was evaluated across historical results versus rescored results, historical results versus re-stained results, and leading center results versus local site results. Clinicopathological characteristics were retrospectively analyzed as well.
resultsHER2 IHC 0, IHC 1+, IHC 2+, and IHC 3 + were identified in 682 (23.8%), 871 (30.4%), 801 (27.9%), and 515 (18.0%) cases, respectively. HER2-positive, HER2-low, and HER2 IHC 0 (HER2-ultralow and IHC null) were identified in 21.7%, 54.5%, and 23.8% of cases, respectively. The prevalence of HER2-ultralow and IHC null was 10.6% and 13.2%, respectively. The concordance for HER2-ultralow was 43.3%; 30% of cases that were scored as HER2-ultralow at local sites were rescored as HER2-null and 26.7% of cases were rescored as IHC 1 + at the leading site. Overall, there was substantial agreement (83.1%) between rescored and historical IHC results. A high concordance rate of 91.7% was observed for HER2-low classification.
conclusionsThis is the first multicenter study to determine the prevalence of HER2-low and HER2-ultralow based on rescored results in the Chinese breast cancer population. The concordance analysis carries important implications for the diagnosis of HER2-low and HER2-ultralow cases in clinical practice. The relatively low concordance in identifying HER2-ultralow suggested that the reproducibility of scoring HER2-ultralow needed to be improved through training.
trial registrationClinicalTrials.gov identifier NCT05203458.
Indexed as
Identifiers
What OpenQuestion holds
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.