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Genes usually encode proteins necessary for the proper functioning of a healthy cell. Mutations can often cause changes to the gene expression pattern, thereby altering the phenotype.
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Updated: Oct 20, 2025

Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells
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HER2-Low Breast Cancers.

Huina Zhang1, Hani Katerji1, Bradley M Turner1

  • 1Department of Pathology, University of Rochester Medical Center, Rochester, NY, USA.

American Journal of Clinical Pathology
|September 14, 2021
PubMed
Summary
This summary is machine-generated.

HER2-low breast cancer, defined by specific human epidermal growth factor receptor 2 (HER2) testing results, shows promise for novel targeted therapies. Further research is needed to refine definitions and testing for this patient group.

Keywords:
Antibody-drug conjugateBreast cancerHER2-lowHER2-targeted therapy

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Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers
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Area of Science:

  • Oncology
  • Molecular Biology
  • Clinical Pathology

Background:

  • Recent clinical trials highlight benefits of novel therapies for breast cancer patients with specific HER2 (human epidermal growth factor receptor 2) expression levels.
  • A new classification of "HER2-low" breast cancer has emerged, influencing ongoing clinical trial designs and therapeutic strategies.

Purpose of the Study:

  • To review existing literature on HER2-low breast cancer.
  • To discuss the implications of HER2-low classification in breast cancer treatment and diagnostics.

Main Methods:

  • Conducted a PubMed literature search using keywords related to HER2-low breast cancer.
  • Included major relevant studies presented at international breast cancer conferences.

Main Results:

  • HER2-low breast cancer is characterized by HER2 immunohistochemical (IHC) scores of 1+ or 2+ with negative in situ hybridization (ISH).
  • This category exhibits significant biological heterogeneity.
  • Next-generation HER2-targeting antibody-drug conjugates show clinical activity in HER2-low breast cancers, but current testing methodologies have limitations.

Conclusions:

  • Novel HER2-targeted therapies demonstrate efficacy in advanced HER2-low breast cancers.
  • The definition, reliable testing methodologies, and underlying biology of HER2-low breast cancer require further clarification.
  • Clinical interpretation of HER2 status may evolve to include the HER2-low category.