Trial reportBreast cancer research : BCR2017
An international reproducibility study validating quantitative determination of ERBB2, ESR1, PGR, and MKI67 mRNA in breast cancer using MammaTyper®.
Trial report in Breast cancer research : BCR, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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Who cites it
23 citing papers in PubMed, 39 citations in OpenAlex.
- Androgen receptor expression and response to chemotherapy in breast cancer patients treated in the neoadjuvant TECHNO and PREPARE trial.British journal of cancer · 2019Trial
- Integrating Spatial Multi-Omics and Machine Learning to Unravel the Role of PANoptosis in Bladder Cancer Prognosis and Immunotherapy Response.Oncology research · 2025Article
- Multi-layered knowledge graph neural network reveals pathway-level agreement of three breast cancer multi-gene assays.Computational and structural biotechnology journal · 2024Article
- Concordance of HER2-low scoring in breast carcinoma among expert pathologists in the United Kingdom and the republic of Ireland -on behalf of the UK national coordinating committee for breast pathology.Breast (Edinburgh, Scotland) · 2023Article
- Multiplex imaging of breast cancer lymph node metastases identifies prognostic single-cell populations independent of clinical classifiers.Cell reports. Medicine · 2023Article
- ELISA-like QDB method to meet the emerging need of Her2 assessment for breast cancer patients.Frontiers in oncology · 2023Article
- Adjuvant Treatment for Breast Cancer Patients Using Individualized Neoantigen Peptide Vaccination-A Retrospective Observation.Vaccines · 2022Article
- Comparison of immunohistochemistry and RT-qPCR for assessing ER, PR, HER2, and Ki67 and evaluating subtypes in patients with breast cancer.Breast cancer research and treatment · 2022Article
- Association of Proliferative Activity in Invasive Ductal Carcinoma Breast in Pakistani Population.Asian Pacific journal of cancer prevention : APJCP · 2022Article
- Use of the Xpert Breast Cancer STRAT4 for Biomarker Evaluation in Tissue Processed in a Developing Country.American journal of clinical pathology · 2021Article
- Prognostic Impact of Immunoglobulin Kappa C (Cancers · 2021Article
- Tumor Microenvironment Subtypes and Immune-Related Signatures for the Prognosis of Breast Cancer.BioMed research international · 2021Article
- Looking for more reliable biomarkers in breast cancer: Comparison between routine methods and RT-qPCR.PloS one · 2021Article
- A 'Real-Life' Experience on Automated Digital Image Analysis of FGFR2 Immunohistochemistry in Breast Cancer.Diagnostics (Basel, Switzerland) · 2020Article
- Bioinformatics Analysis Identifies the Estrogen Receptor 1 (ESR1) Gene and hsa-miR-26a-5p as Potential Prognostic Biomarkers in Patients with Intrahepatic Cholangiocarcinoma.Medical science monitor : international medical journal of experimental and clinical research · 2020Article
- Performance Characteristics of the BluePrint® Breast Cancer Diagnostic Test.Translational oncology · 2020Article
- Polymorphism of XRCC3 in Egyptian Breast Cancer Patients.Pharmacogenomics and personalized medicine · 2020Article
- Selecting Appropriate Reference Genes for Quantitative Real-Time Polymerase Chain Reaction Studies in Isolated and Cultured Ocular Surface Epithelia.Scientific reports · 2019Article
- Ki-67 assessment in early breast cancer: SAKK28/12 validation study on the IBCSG VIII and IBCSG IX cohort.Scientific reports · 2019Article
- Observational
Corrections and comments
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Authors and funding
21 authors at 13 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAccurate determination of the predictive markers human epidermal growth factor receptor 2 (HER2/ERBB2), estrogen receptor (ER/ESR1), progesterone receptor (PgR/PGR), and marker of proliferation Ki67 (MKI67) is indispensable for therapeutic decision making in early breast cancer. In this multicenter prospective study, we addressed the issue of inter- and intrasite reproducibility using the recently developed reverse transcription-quantitative real-time polymerase chain reaction-based MammaTyper® test.
methodsTen international pathology institutions participated in this study and determined messenger RNA expression levels of ERBB2, ESR1, PGR, and MKI67 in both centrally and locally extracted RNA from formalin-fixed, paraffin-embedded breast cancer specimens with the MammaTyper® test. Samples were measured repeatedly on different days within the local laboratories, and reproducibility was assessed by means of variance component analysis, Fleiss' kappa statistics, and interclass correlation coefficients (ICCs).
resultsTotal variations in measurements of centrally and locally prepared RNA extracts were comparable; therefore, statistical analyses were performed on the complete dataset. Intersite reproducibility showed total SDs between 0.21 and 0.44 for the quantitative single-marker assessments, resulting in ICC values of 0.980-0.998, demonstrating excellent agreement of quantitative measurements. Also, the reproducibility of binary single-marker results (positive/negative), as well as the molecular subtype agreement, was almost perfect with kappa values ranging from 0.90 to 1.00.
conclusionsOn the basis of these data, the MammaTyper® has the potential to substantially improve the current standards of breast cancer diagnostics by providing a highly precise and reproducible quantitative assessment of the established breast cancer biomarkers and molecular subtypes in a decentralized workup.
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