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<p>Persistent circulating tumor DNA (ctDNA) during neoadjuvant treatment (NAT) of early breast cancer (EBC) indicates high-risk disease. Similarly, detection of ctDNA post-resection indicates molecular residual disease (MRD) and impending relapse. For ctDNA to be integrated into EBC management, accessible and scalable diagnostics are required. Here we apply an ultrasensitive, personalized tumor-informed approach to ctDNA evaluation predicated on analyses of structural variants (SVs) using a novel digital PCR (dPCR) multiplex&#xa0;SV technology. 136 patients eligible for NAT (29.4% TNBC, 44.9% HR+ /HER2− and 24.3% HER2+), enrolled between December 2014 and March 2019, were analyzed from the prospective SCAN-B study (NCT02306096, substudy NeoCircle). ctDNA detection at baseline was 89.7%; end-NAT ctDNA-positivity (21.4%) and NAT ctDNA-non-response (13.1%) were significant predictors of disease recurrence and death, and both superior to pathologic complete response. Detection of ctDNA post-operatively or during adjuvant monitoring was significantly associated with distant recurrence (median lead-time 13.8 months, range 0–47.7 months). These findings validate SVs as an MRD analyte and provide evidence for clinical use of this approach in EBC.</p>

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NeoCircle: pre- and post-operative circulating tumor DNA dynamics predicts survival in neoadjuvant-treated early breast cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月26日

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  • Anthony M George,
  • Yilun Chen,
  • Sergii Gladchuk,
  • Miguel Alcaide,
  • Hina Dalal,
  • Pei Meng,
  • Christian Brueffer,
  • Hani Saghir,
  • Siker Kimbung,
  • Kristina Aaltonen,
  • Lucia Oton,
  • Christopher Rushton,
  • Sofia Birkeälv,
  • Mats Jönsson,
  • Sophia Zackrisson,
  • Ida Skarping,
  • Daniel Förnvik,
  • Lina Zander,
  • Gabriella Honeth,
  • Samuel Woodhouse,
  • Karen Howarth,
  • Åke Borg,
  • Anna Ehinger,
  • Martin Malmberg,
  • Lisa Rydén,
  • Niklas Loman,
  • Lao H Saal

摘要

Persistent circulating tumor DNA (ctDNA) during neoadjuvant treatment (NAT) of early breast cancer (EBC) indicates high-risk disease. Similarly, detection of ctDNA post-resection indicates molecular residual disease (MRD) and impending relapse. For ctDNA to be integrated into EBC management, accessible and scalable diagnostics are required. Here we apply an ultrasensitive, personalized tumor-informed approach to ctDNA evaluation predicated on analyses of structural variants (SVs) using a novel digital PCR (dPCR) multiplex SV technology. 136 patients eligible for NAT (29.4% TNBC, 44.9% HR+ /HER2− and 24.3% HER2+), enrolled between December 2014 and March 2019, were analyzed from the prospective SCAN-B study (NCT02306096, substudy NeoCircle). ctDNA detection at baseline was 89.7%; end-NAT ctDNA-positivity (21.4%) and NAT ctDNA-non-response (13.1%) were significant predictors of disease recurrence and death, and both superior to pathologic complete response. Detection of ctDNA post-operatively or during adjuvant monitoring was significantly associated with distant recurrence (median lead-time 13.8 months, range 0–47.7 months). These findings validate SVs as an MRD analyte and provide evidence for clinical use of this approach in EBC.