Prospective circulating tumour DNA surveillance in patients with early high-risk hormone receptor positive, HER2-negative breast cancer in the TRAK-ER study.

In TRAK-ER early high-risk ER-positive, HER2-negative breast cancer, ctDNA is detected in 5.0% at the first test and 23.7% cumulatively by 5 years post-surgery.

• Why it matters: CtDNA detection during adjuvant endocrine therapy is linked to recurrence, but prospective surveillance performance and how it aligns with radiological relapse are needed to guide treatment changes.
• What they did: TRAK-ER enrolled 1133 patients undergoing 3-monthly ctDNA surveillance for up to 3 years during adjuvant endocrine therapy, using a tumour-informed Labcorp assay, with staging scans and randomization after ctDNA detection.
• The result: Patient-level detection was 12.0% (109/912), with 1.1% (10/912) showing clinical recurrence without prior ctDNA detection; first-test ctDNA detection had higher radiological recurrence (65.9% vs 26.6%, P<0.001).

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