ArticleNPJ breast cancer2025
HER2-low and ultralow expression of invasive breast carcinoma: clinicopathological features and immunohistochemical consistency analysis.
Article in NPJ breast cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Controllable Cascade Aggregation Ion Programmed Nanomachines and Simple Isolation Enable Tumor-Derived Small Extracellular Vesicles Detection for Enhanced Breast Cancer Assessment.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- HER2-Low Breast Cancer: Biological Framework and Determinants of HER2 Instability.Medicina (Kaunas, Lithuania) · 2026Review
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
The DESTINY-Breast06 trial demonstrated survival benefits of trastuzumab deruxtecan (T-DXd) in human epidermal growth factor receptor 2 (HER2)-low/ultralow metastatic breast cancer. However, the associated clinicopathological features, HER2 testing consistency, and utility of artificial intelligence (AI)-assisted interpretation remain unclear. We analyzed 1455 HER2-non-amplified cases and conducted a multicenter ring study across 45 laboratories, with 209 tissue sections evaluated by manual and AI-assisted scoring. Compared to HER2-ultralow cases, HER2-null tumors exhibited higher histological grade (p < 0.001), lower estrogen receptor (ER) expression, and elevated Ki-67 (all P < 0.05). Triple-negative breast cancer (TNBC) patients in the HER2-null subgroup were significantly younger (P = 0.040). Significant staining variability was observed between antibodies: the 4B5 clone was associated with more HER2 0 and 1+ scores, while MXR001 yielded higher rates of HER2-low results (P < 0.05). Inter-laboratory concordance was moderate (68.89%), being poorest for HER2 1+ (57.58%; Kappa = 0.566). AI-assisted interpretation improved observer agreement (Kappa: 0.703 vs. 0.610 in non-amplified cases) and reduced ambiguous immunohistochemistry (IHC) 2+/0 assignments. These findings delineate distinct clinicopathological characteristics of HER2-ultralow/null tumors, highlight HER2 IHC reproducibility challenges, and validate AI as an effective tool for standardizing scoring to optimize patient selection for T-DXd therapy.
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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.