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Integrating PIK3CA Testing into Clinical Practice for Advanced HR+/HER2- Breast Cancer: An Expert Consensus.

Carmine De Angelis1, Dario de Biase2, Lorenzo Gerratana3

  • 1Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Via Mariano Semmola, 52, Napoli 80131, Italy; Clinical and Translational Oncology, Scuola Superiore Meridionale, Naples, Italy.

Breast (Edinburgh, Scotland)
|April 18, 2026
PubMed
Summary
This summary is machine-generated.

Standardizing PIK3CA testing is crucial for advanced HR+/HER2- breast cancer patients. This consensus provides guidelines for molecular testing, improving endocrine therapy resistance management.

Keywords:
Expert consensusHR+/HER2− breast cancerLiquid biopsyNGSPIK3CA

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Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Genetics

Background:

  • PI3K/AKT/mTOR pathway alterations drive endocrine therapy resistance in HR+/HER2- breast cancer.
  • Activating PIK3CA mutations are key therapeutic targets for inhibitors like alpelisib and inavolisib.

Purpose of the Study:

  • To establish shared recommendations for molecular testing of PIK3CA in advanced HR+/HER2- breast cancer.
  • To address preanalytical, analytical, and clinical-therapeutic aspects of PIK3CA testing.

Main Methods:

  • A multidisciplinary panel of Italian experts convened for a structured consensus process.
  • Recommendations were developed covering various stages of molecular testing and clinical integration.

Main Results:

  • 23 out of 29 statements achieved full consensus (100% agreement).
  • Recommendations cover sample selection, analytical methods, sensitivity, reporting, and interpretation.
  • Guidance is offered for non-canonical variants and other PI3K/AKT/mTOR pathway genes.

Conclusions:

  • This consensus provides operational and interpretative guidelines for PIK3CA testing and related gene assessment.
  • The recommendations aim to standardize testing and promote a harmonized approach to patient care.
  • The guidelines align with the latest scientific evidence in breast cancer treatment.