Dynamic biomarkers in hormone receptor-positive/HER2-negative breast cancer trials: a new hope for precision oncology

Giuseppe Di Grazia1,2, Rodrigo Sánchez-Bayona3,4, Climent Casals-Pascual5,6,7,8

  • 1Department of Human Pathology "G. Barresi", University of Messina, Messina, Italy.

NPJ Breast Cancer
|January 28, 2026
PubMed

Insights

Adaptive treatment strategies are needed for hormone receptor-positive/HER2-negative breast cancer. Dynamic biomarkers from biopsies, imaging, and microbiome profiling can guide proactive oncology decisions.

Area of Science:

  • Oncology
  • Biomarkers
  • Translational Research

Background:

  • Hormone receptor-positive/HER2-negative breast cancer (HR+/HER2– BC) is known to evolve under therapy.
  • Current treatment strategies often lack adaptability to these dynamic tumor changes.
  • There is a need for advanced biomarkers to guide personalized treatment adjustments.

Purpose of the Study:

  • To review emerging dynamic biomarkers for guiding therapeutic decisions in HR+/HER2– BC.
  • To explore how these biomarkers capture temporal changes in the tumor and host.
  • To contrast academic and industry approaches to biomarker-driven clinical trials.

Main Methods:

  • Review of current literature on dynamic biomarkers.
  • Categorization of biomarkers into tissue-based, liquid-based, metabolic imaging, and microbiome profiling.
  • Analysis of academic versus industry clinical trial designs.

Main Results:

  • Dynamic biomarkers offer real-time insights into treatment response and resistance mechanisms.
  • Tissue and liquid biopsies, metabolic imaging, and microbiome profiling are key areas of biomarker development.
  • Significant differences exist in the approaches of academic institutions and industry in leveraging these biomarkers.

Conclusions:

  • Dynamic biomarkers are crucial for developing adaptive treatment strategies in HR+/HER2– BC.
  • A shift towards proactive, biomarker-guided oncology is necessary.
  • Collaborative efforts and innovative clinical trial designs are needed to integrate these biomarkers effectively into clinical practice.

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