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: Open to recruitment
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, who have completed standard therapy.
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.
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]
Sponsor: The Institute of Cancer Research
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).
Further information including recruitment progress is available from the following link:
UK Clinical Trials Gateway
A lay summary in plain English is available from Cancer Research UK by following the link:
Cancer Research UK (c-TRAK TN)
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