A UK-led trial that tests the blood of women with high-risk hormone-receptor-positive breast cancer every three months, and offers a change of treatment to those whose blood turns positive before scans show anything.
TRAK-ER (NCT04985266), sponsored by the Royal Marsden with Invitae among its collaborators, has two phases: ctDNA surveillance with a tumour-informed assay from Labcorp, then randomisation of ctDNA-positive patients without radiological recurrence to palbociclib plus fulvestrant or standard endocrine therapy (tamoxifen, letrozole, anastrozole or exemestane), for up to 24 months. The registry lists 1,100 planned participants and an estimated primary completion in September 2027.
The surveillance phase reported in Annals of Oncology in 2026: of 912 patients who started surveillance, 12.0 per cent had ctDNA detected, panel design failed in 16.1 per cent, and 65.9 per cent of those detected on their first test already had radiological recurrence, against 26.6 per cent of those first detected later. The authors conclude that ultrasensitive assays are required to find relapse before it is clinically evident. The randomised treatment phase has not reported.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,100 enrolled.
Shares Invitae, Labcorp, Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD).
Shares Naming which clone or phenotype is left after treatment, Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).
Shares Anastrozole, Exemestane, Letrozole (and other aromatase inhibitors), Tamoxifen.
Shares Naming which clone or phenotype is left after treatment, Letrozole (and other aromatase inhibitors), Palbociclib, Fulvestrant.
Shares Anastrozole, Exemestane, Letrozole (and other aromatase inhibitors), Tamoxifen.
Shares c-TRAK TN, Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).
Shares Naming which clone or phenotype is left after treatment, Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).
Shares Letrozole (and other aromatase inhibitors), Palbociclib, Fulvestrant, Estrogen receptor (ERα).
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/