ArticleESMO open2024
Analytical validation of HER2DX genomic test for early-stage HER2-positive breast cancer.
Article in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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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.
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Who cites it
21 citing papers in PubMed, 25 citations in OpenAlex.
- Talimogene laherparepvec and atezolizumab in HER2-negative breast cancer following neoadjuvant chemotherapy: a window-of-opportunity phase II trial (SOLTI-1503 PROMETEO).Nature communications · 2026Trial
- HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy.Nature communications · 2025Trial
- HER2DX in HER2-positive inflammatory breast cancer: correlative insights and comparative analysis with noninflammatory breast cancers.ESMO open · 2025Trial
- HER2DX Genomic Assay in HER2-Positive Early Breast Cancer Treated with Trastuzumab and Pertuzumab: A Correlative Analysis from the PHERGain Phase II Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Pathologic Complete Response (pCR) Rate and Predictors of Response to Taxane, Trastuzumab, and Pertuzumab in HER2‑Positive Breast Cancer: Secondary Analyses of EA1181/CompassHER2 pCR.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Article
- Implementation of HER2DX Scores into Treatment Decisions in Early-Stage HER2-Positive Breast Cancer.International journal of molecular sciences · 2026Observational
- Quantitative HER2 tissue and plasma profiling predicts the activity of trastuzumab deruxtecan for breast cancer.NPJ precision oncology · 2026Article
- Validation of the HER2DX genomic test in first-line advanced HER2-positive breast cancer treated with trastuzumab, pertuzumab, and taxane.NPJ breast cancer · 2026Article
- Associations of the HER2DX Genomic Test with Biological and Pathologic Features in HER2-Positive Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Evolving Concepts and Contemporary Management of Early-Stage Breast Cancer: An Evidence-Based Approach to Grey Zones from a Comprehensive Breast Unit Part 2: Systemic Treatment.European journal of breast health · 2025Article
- Real-world outcomes of early-stage HER2-positive breast cancer patients treated with adjuvant paclitaxel and trastuzumab.NPJ breast cancer · 2025Article
- HER2/CEP17 ratio predicts residual cancer burden after neoadjuvant dual HER2 blockade: real-world data in patients with primary HER2-amplified breast cancer.Virchows Archiv : an international journal of pathology · 2025Article
- Clinical decision impact of HER2DX, an algorithm-powered genomic diagnostic in early-stage HER2-positive breast cancer: results from a prospective real-world study.ESMO real world data and digital oncology · 2025Article
- Paclitaxel-related type I Kounis Syndrome in a very young patient with HER2-positive breast cancer and the role of genomics to disentangle a complex therapeutic scenario: a case report and narrative review.Breast (Edinburgh, Scotland) · 2025Review
- Bridging the gap: overcoming barriers to implementing gene expression profiling in clinical practice.ESMO real world data and digital oncology · 2025Article
- Multimodal data integration in early-stage breast cancer.Breast (Edinburgh, Scotland) · 2025Review
- The Application of Traditional Chinese Medicine-Derived Formulations in Cancer Immunotherapy: A Review.Cancer management and research · 2025Review
- Case Report: Personalized management of HER2-positive breast cancer with advanced nodal disease during pregnancy: a clinical case and review.Frontiers in oncology · 2025Article
- Dual HER2 inhibition: mechanisms of synergy, patient selection, and resistance.Nature reviews. Clinical oncology · 2024Review
- Article
Corrections and comments
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Authors and funding
40 authors at 10 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHER2DX, a multianalyte genomic test, has been clinically validated to predict breast cancer recurrence risk (relapse risk score), the probability of achieving pathological complete response post-neoadjuvant therapy (pCR likelihood score), and individual ERBB2 messenger RNA (mRNA) expression levels in patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. This study delves into the comprehensive analysis of HER2DX's analytical performance. MATERIALS AND
methodsPrecision and reproducibility of HER2DX risk, pCR, and ERBB2 mRNA scores were assessed within and between laboratories using formalin-fixed paraffin-embedded (FFPE) tumor tissues and purified RNA. Robustness was appraised by analyzing the impact of tumor cell content and protocol variations including different instruments, reagent lots, and different RNA extraction kits. Variability was evaluated across intratumor biopsies and genomic platforms [RNA sequencing (RNAseq) versus nCounter], and according to protocol variations.
resultsPrecision analysis of 10 FFPE tumor samples yielded a maximal standard error of 0.94 across HER2DX scores (1-99 scale). High reproducibility of HER2DX scores across 29 FFPE tumors and 20 RNAs between laboratories was evident (correlation coefficients >0.98). The probability of identifying score differences >5 units was ≤5.2%. No significant variability emerged based on platform instruments, reagent lots, RNA extraction kits, or TagSet thaw/freeze cycles. Moreover, HER2DX displayed robustness at low tumor cell content (10%). Intratumor variability across 212 biopsies (106 tumors) was <4.0%. Concordance between HER2DX scores from 30 RNAs on RNAseq and nCounter platforms exceeded 90.0% (Cohen's κ coefficients >0.80).
conclusionsThe HER2DX assay is highly reproducible and robust for the quantification of recurrence risk, pCR likelihood, and ERBB2 mRNA expression in early-stage HER2-positive breast cancer.
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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.