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Updated: Jun 25, 2025

Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers
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Navigating HER2-Low Testing in Invasive Breast Cancer: Update Recommendations for Pathologists.

Leticia Bornstein-Quevedo1, Jazmín de Anda-González2, Cesar Octavio Lara-Torres3

  • 1Department of Immunohistochemistry and Molecular Pathology, InmunoQ, Mexico City 03200, Mexico.

Journal of Personalized Medicine
|May 25, 2024
PubMed
Summary
This summary is machine-generated.

Distinguishing HER2-low from HER2-negative breast cancer is crucial. New antibody-drug conjugates show promise for HER2-low breast cancer (BC), necessitating standardized testing for better patient care.

Keywords:
HER2HER2-low testingHER2-targeted therapyIHC assaysISHbreast cancermetastatic diseasetrastuzumab deruxtecan

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Area of Science:

  • Oncology
  • Pathology
  • Biomarker Research

Background:

  • Accurate distinction between HER2-low and HER2-negative breast cancer is increasingly important.
  • Novel antibody-drug conjugates (ADCs) demonstrate efficacy in HER2-low expressing breast cancer (BC).
  • Current HER2 testing guidelines are dichotomous (positive/negative), not accounting for HER2-low expression.

Purpose of the Study:

  • To review the evolution and updates of ASCO/CAP guidelines for HER2 testing in breast cancer.
  • To highlight the significance of the emerging HER2-low concept and its implications for treatment.
  • To present updated Mexican recommendations for HER2 status evaluation, incorporating the HER2-low classification.

Main Methods:

  • Review of current ASCO/CAP guidelines and literature on HER2 testing.
  • Analysis of the impact of novel ADCs on HER2-low breast cancer treatment strategies.
  • Development of updated national recommendations for HER2 assessment in breast cancer.

Main Results:

  • The HER2-low classification represents a significant advancement in breast cancer diagnostics.
  • Standardization of HER2 testing is needed to accurately identify patients who may benefit from HER2-targeted therapies.
  • Updated guidelines and national recommendations are essential for personalized medicine approaches.

Conclusions:

  • Accurate HER2 status assessment, including the HER2-low category, is vital for effective breast cancer management.
  • Adoption of standardized testing protocols and updated guidelines will improve patient outcomes.
  • Pathologist commitment to theranostic biomarker quality is critical for optimal oncology care in Mexico and globally.