c-TRAK TN analysis: tissue-free versus tumour-informed ctDNA assays for residual disease in early triple-negative breast cancer
A blood test that needs no tumour sample found leftover cancer DNA in a third of women after treatment for triple-negative breast cancer, and those women were far more likely to relapse; it agreed closely with the tests that first sequence the tumour.
Overview
Prognostic and exploratory analysis of the ctDNA surveillance period of c-TRAK TN, a multicentre phase 2 study in triple-negative breast cancer at moderate to high risk of recurrence. Plasma was collected every three months for up to two years after adjuvant therapy. A tissue-free methylation assay was compared with digital PCR and whole-exome-powered tumour-informed assays across 1,026 samples from 159 patients.
- The tissue-free assay detected ctDNA in 54 of 159 patients (34 percent).
- Detection was strongly associated with recurrence: hazard ratio 27.2 (95 percent CI 13.7 to 54.2) for recurrence-free survival.
Residual-disease testing may not need the tumour to be sequenced first, which would remove the slowest step of tumour-informed assays; the comparison with tumour-informed results in the same patients is the evidence that matters.
- Exploratory analysis of a phase 2 study, not a randomised comparison of assays.
- Single cancer type and a moderate to high-risk population; performance in other settings is untested.
- Follow-up through January 2023 with analysis in 2025 to 2026.
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