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Personalized ctDNA detection and genomic profiling in the NeoRHEA Study.

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Circulating tumor DNA (ctDNA) shows promise for early HR+/HER2- breast cancer. Baseline ctDNA levels predicted poor response to neoadjuvant therapy, highlighting its potential as a predictive biomarker.

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Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Genomics

Background:

  • Circulating tumor DNA (ctDNA) is an emerging biomarker for early hormone receptor-positive (HR+), HER2-negative breast cancer.
  • The NeoRHEA trial investigated neoadjuvant palbociclib plus endocrine therapy in this patient population.

Purpose of the Study:

  • To assess the utility of ctDNA as a biomarker in early HR+/HER2- breast cancer treated with neoadjuvant therapy.
  • To correlate ctDNA dynamics and genomic alterations with treatment response.

Main Methods:

  • The RaDaR assay was used to detect ctDNA in plasma samples from the NeoRHEA trial.
  • Samples were collected at multiple time points: pre-treatment, post-cycle 1, pre-surgery, and 1 month post-surgery.
  • Genomic alterations (MYC, PIK3CA, FAT1) were analyzed.

Main Results:

  • Baseline ctDNA was detected in 55% of patients, decreasing significantly during treatment and becoming undetectable post-surgery.
  • Higher baseline ctDNA was associated with grade 3 tumors and higher residual cancer burden (RCB) 3.
  • Specific genomic alterations (MYC, PIK3CA, FAT1) were enriched in different response groups.

Conclusions:

  • Baseline ctDNA detection is a significant predictor of poor response to neoadjuvant palbociclib plus endocrine therapy in HR+/HER2- breast cancer.
  • ctDNA serves as a valuable biomarker for guiding treatment decisions in this breast cancer subtype.
  • Further research into ctDNA dynamics and genomic profiling can refine treatment strategies.