{"entity":{"id":"paper-cunningham-trak-er-surveillance-ann-oncol-2026","kind":"paper","name":"Prospective circulating tumour DNA surveillance in patients with early high-risk hormone receptor positive, HER2-negative breast cancer in the TRAK-ER study","aka":[],"tldr":"In TRAK-ER, three-monthly blood tests found tumour DNA in about one in eight women with high-risk hormone-receptor-positive breast cancer, but two thirds of those found on their first test already had cancer visible on scans.","summary":"TRAK-ER enrols patients with high-risk ER-positive, HER2-negative early breast cancer for three-monthly ctDNA surveillance for up to three years during adjuvant endocrine therapy, using a tumour-informed assay from Labcorp; on detection, patients have staging scans and, without radiological recurrence, are randomised to palbociclib plus fulvestrant or standard endocrine therapy. This protocol-specified analysis reports the surveillance phase. 1,133 patients were registered by September 2025; panel design failed in 16.1 per cent (178 of 1,106) and 912 started surveillance, with 5,810 tests (median 7 per patient). Detection was 5.0 per cent on the first test and 1.3 per cent on later tests; patient-level detection was 12.0 per cent (109 of 912), and 1.1 per cent (10 of 912) had a clinical recurrence without prior ctDNA detection. Estimated cumulative detection at five years after surgery was 23.7 per cent (95% CI 14.5 to 31.9). Of patients detected on their first test, 65.9 per cent (29 of 44) already had radiological recurrence, against 26.6 per cent (17 of 64) of those first detected later. The authors conclude that ultrasensitive assays detecting ctDNA at low levels are required to identify patients before clinical recurrence.","asOf":"2026-11-04","links":[{"label":"Cunningham et al., Ann Oncol 2026 (TRAK-ER)","url":"https://doi.org/10.1016/j.annonc.2026.10.1292"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/42946309/"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":["diagnostics"],"technologies":["mrd-testing"],"targets":[],"drugs":["palbociclib","fulvestrant"],"companies":["labcorp"],"institutions":[],"pathways":[],"terms":["mrd","ctdna","tumour-informed-assay"],"trials":["trak-er"],"people":[],"bottlenecks":["b-subclone-attribution-residual-disease"],"keyPapers":[],"journals":["annals-of-oncology"],"dependsOn":[],"notes":[],"journal":"Annals of Oncology","year":2026,"doi":"10.1016/j.annonc.2026.10.1292","pmid":"42946309","authors":"Cunningham N, Swift C, Cutts RJ, et al.","paperType":"observational","findings":["Panel design failed in 16.1% (178 of 1,106).","Patient-level ctDNA detection 12.0% (109 of 912); 5-year cumulative 23.7%.","Radiological recurrence at detection in 65.9% of first-test positives against 26.6% of later positives."],"whatItMeans":"Surveillance blood tests in hormone-receptor-positive breast cancer find relapse, but often too late to act on it before scans show it. The randomised question, whether treating at molecular relapse helps, has not yet reported.","caveats":["Surveillance phase only; the treatment phase is ongoing.","One assay, tumour-informed, from Labcorp."],"participants":912},"route":"/key-papers/paper-cunningham-trak-er-surveillance-ann-oncol-2026/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"}],"technology":[{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"}],"drug":[{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"},{"id":"palbociclib","kind":"drug","name":"Palbociclib","route":"/drugs/palbociclib/"}],"company":[{"id":"labcorp","kind":"company","name":"Labcorp","route":"/companies/labcorp/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"},{"id":"tumour-informed-assay","kind":"term","name":"Tumour-informed versus tumour-naive ctDNA assays","route":"/terms/tumour-informed-assay/"}],"trial":[{"id":"trak-er","kind":"trial","name":"TRAK-ER","route":"/trials/trak-er/"}],"bottleneck":[{"id":"b-subclone-attribution-residual-disease","kind":"bottleneck","name":"Naming which clone or phenotype is left after treatment","route":"/bottlenecks/b-subclone-attribution-residual-disease/"}],"journal":[{"id":"annals-of-oncology","kind":"journal","name":"Annals of Oncology","route":"/journals/annals-of-oncology/"}],"biomarker":[{"id":"ctdna-mrd-positive","kind":"biomarker","name":"ctDNA MRD positivity (molecular residual disease after curative treatment)","route":"/biomarkers/ctdna-mrd-positive/"}]}}