c-TRAK TN: A randomised trial utilising ctDNA mutation tracking to detect minimal residual disease and trigger intervention in patients with moderate and high risk early stage triple negative breast cancer.
Disease site: Breast cancer
Treatment modality: Systemic therapy
Status: In follow-up
Trial details
c-TRAK TN is a phase II, multicentre, randomised trial with ctDNA screening. The trial consists of tissue and ctDNA screening and a therapeutic trial for patients with moderate or high-risk early stage triple negative breast cancer with no evidence of distant metastatic disease.
If eligibility is confirmed following tissue screening, patients will undergo blinded serial ctDNA screening for ctDNA detection with randomisation into the therapeutic trial triggered by the detection of minimal residual disease (indicated by a ctDNA positive result) on or before their 12 month ctDNA screening assessment.
c-TRAK TN aims to sequence archival tumour tissue from approximately 200 patients in order to recruit approximately 150 patients into ctDNA screening. Of those 150 patients, up to 68 patients will be randomised to either observation or pembrolizumab treatment. Following completion of 1 year of ctDNA screening or pembrolizumab treatment (followed by another year of ctDNA screening), patients will be followed up every 6 months until disease recurrence.
Further information for potential participants
Patient Information Sheet (Amendment)
Patient Information Sheet
Patient Information Sheet (Registration)
Further information
Chief Investigator: Professor Nicholas Turner, The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: [email protected]
ISRCTN: 12569958
Sponsor: The Institute of Cancer Research
Funding:
National Institute for Health Research Biomedical Research Centre at the Royal Marsden / Institute of Cancer Research, Merck Sharp and Dohme Ltd. and ICR-CTSU’s Clinical Trials Core Programme Grant from Cancer Research UK (CRUKE/16/024).
View c-TRAK TN on the National Institute for Health Research website: NIHR - Be Part Of Research
A lay summary in plain English is available from Cancer Research UK by following the link:
Cancer Research UK (c-TRAK TN)
Flyers:
c-TRAK TN flyer for patients v1.0
c-TRAK TN flyer for healthcare professionals v2.0
Publications and presentations
There have been no presentations or publications to date.