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Purpose <p>Circulating tumor DNA (ctDNA) enables early detection of ESR1 mutations in hormone receptor–positive, HER2-negative metastatic breast cancer. Building on the PADA-1, the SERENA-6 trial demonstrated significant progression-free survival and quality-of-life benefits from ctDNA-guided early endocrine switching before radiologic progression.</p> Methods <p>We examine the evolving clinical utility of liquid biopsy in this setting and review evidence from trials evaluating biomarker-guided treatment adaptation. We also compare imaging- versus biomarker-guided strategies.</p> Conclusion <p>This review outlines the key challenges to validating and implementing ctDNA-guided early endocrine switching in routine clinical practice and discusses its potential to reshape monitoring and decision-making in metastatic hormone receptor–positive, HER2-negative breast cancer.</p>

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The promise of ctDNA-based, molecularly-driven early switch therapy from PADA-1 to SERENA-6

  • 期刊论文

  • 发表日期：

    2025年11月21日

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  • Leandro Jonata Carvalho Oliveira,
  • Max Senna Mano,
  • Carlos Barrios,
  • Rodrigo Dienstmann

摘要

Purpose

Circulating tumor DNA (ctDNA) enables early detection of ESR1 mutations in hormone receptor–positive, HER2-negative metastatic breast cancer. Building on the PADA-1, the SERENA-6 trial demonstrated significant progression-free survival and quality-of-life benefits from ctDNA-guided early endocrine switching before radiologic progression.

Methods

We examine the evolving clinical utility of liquid biopsy in this setting and review evidence from trials evaluating biomarker-guided treatment adaptation. We also compare imaging- versus biomarker-guided strategies.

Conclusion

This review outlines the key challenges to validating and implementing ctDNA-guided early endocrine switching in routine clinical practice and discusses its potential to reshape monitoring and decision-making in metastatic hormone receptor–positive, HER2-negative breast cancer.