Trial reportBreast cancer research and treatment2014
Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study.
Trial report in Breast cancer research and treatment, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.
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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.
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Who cites it
39 citing papers in PubMed, 64 citations in OpenAlex.
- Trial
- Analytical Validation of Multimodal AI Test Predicting Breast Cancer Recurrence Risk (Ataraxis Breast RISK).Diagnostics (Basel, Switzerland) · 2026Article
- Long-term trends in the incidence of male breast cancer and nomogram for predicting survival in male breast cancer patients: a population-based epidemiologic study.Scientific reports · 2025Article
- Pyrotinib in combination with first-line trastuzumab and docetaxel for patients with HER2-positive metastatic breast cancer: a new therapeutic option?Nature reviews. Clinical oncology · 2024Article
- Correlation of ER, PR, and HER2 at the protein and mRNA levels in Asian patients with operable breast cancer.Bioscience reports · 2022Article
- Clinicopathological features and prognosis of male breast cancer.The Journal of international medical research · 2021Article
- Why is appropriate healthcare inaccessible for many European breast cancer patients? - The EBCC 12 manifesto.Breast (Edinburgh, Scotland) · 2021Article
- Estrogen, progesterone, and human epidermal growth factor receptor 2 discordance between primary and metastatic breast cancer.Breast cancer research and treatment · 2020Article
- Quantification of HER1, HER2 and HER3 by time-resolved Förster resonance energy transfer in FFPE triple-negative breast cancer samples.British journal of cancer · 2020Article
- Triple Discordances in Receptor Status During Breast Cancer Local Progression and Metastases: Case Report and Literature Review.OncoTargets and therapy · 2020Article
- Targeted lapatinib anti-HER2/ErbB2 therapy resistance in breast cancer: opportunities to overcome a difficult problem.Cancer drug resistance (Alhambra, Calif.) · 2020Review
- Article
- Observational
- Hormone- and HER2-receptor assessment in 33,046 breast cancer patients: a nationwide comparison of positivity rates between pathology laboratories in the Netherlands.Breast cancer research and treatment · 2019Article
- Suboptimal concordance in testing and retesting results of triple-negative breast carcinoma cases among laboratories: one institution experience.Cancer cell international · 2019Article
- Basal-like Breast Cancers: From Pathology to Biology and Back Again.Stem cell reports · 2018Review
- Clinical relevance and concordance of HER2 status in local and central testing-an analysis of 1581 HER2-positive breast carcinomas over 12 years.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2018Article
- Concordance between Immunohistochemistry and Microarray Gene Expression Profiling for Estrogen Receptor, Progesterone Receptor, and HER2 Receptor Statuses in Breast Cancer Patients in Lebanon.International journal of breast cancer · 2018Article
- Improving accuracy of breast cancer biomarker testing in India.The Indian journal of medical research · 2017Review
- Central pathology review with two-stage quality assurance for pathological response after neoadjuvant chemotherapy in the ARTemis Trial.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2017Article
Corrections and comments
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Authors and funding
14 authors at 9 institutions in 4 countries.
Funding
Abstract
Choice of therapy for breast cancer relies on human epidermal growth factor receptor-2 (HER2) and estrogen receptor α (ER) status. Before randomization in the phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) trial for HER2-positive disease, HER2 and ER were centrally reviewed by Mayo Clinic (Rochester, MN, and Scottsdale, AZ) for North America and by the European Institute of Oncology (IEO; Milan, Italy) for the rest of world (except China). Discordance rates (local vs. central review) differed between Mayo and IEO. Among locally HER2-positive cases, 5.8 % (Mayo) and 14.5 % (IEO) were centrally HER2 negative. Among locally ER-positive cases, 16.2 % (Mayo) and 4.2 % (IEO) were centrally ER-negative. Among locally ER-negative cases, 3.4 % (Mayo) and 21.4 % (IEO) were centrally ER-positive. We, therefore, performed a ring study to identify features contributing to these differing discordance rates. Mayo and IEO exchanged slides for 25 HER2 and 35 ER locally/centrally discordant cases. Both laboratories performed IHC and FISH for HER2 using the HercepTest(®) and PathVysion HER2 DNA probe kit/HER2/centromere 17 probe mixture. IHC for ER was tested centrally using the monoclonal ER 1D5 antibody (Mayo) or the DAKO cocktail of ER 1D5 and 2.123 antibodies (IEO). Mayo and IEO confirmed the central HER2-negative result in 100 % of 25 cases. Mayo and IEO confirmed the central ER result in 29 (85 %) of 34 evaluable cases. The five Mayo-negative/IEO-positive cases were ER-positive when retested at Mayo using the DAKO ER cocktail. In this ring study, ALTTO ineligibility did not change when HER2 testing was performed by either IEO or Mayo central laboratories. However, a dual antibody ER assay had fewer false-negative test results than an assay with a single antibody, and there was more discordance between the two ER reagents than has been previously reported. Using even slightly different assay methods yielded different results, even between experienced central laboratories.
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