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

Primary Publication: Annals of Oncology:
Published February 2023, available online 22nd November 2022
Turner, N. C., et al. (2022). "Results of the c-TRAK TN trial: a clinical trial utilising ctDNA mutation tracking to detect molecular residual disease and trigger intervention in patients with moderate and high-risk early stage triple negative breast cancer." Annals of Oncology.

Paper: Comparison of circulating tumor DNA assays for Molecular Residual Disease detection in early-stage triple negative breast cancer
Published 04 January 2024
Maria Coakley, Guillermo Villacampa, Prithika Sritharan, Claire Swift, Kathryn Dunne, Lucy Kilburn, Katie Goddard, Christodoulos Pipinikas, Patricia Rojas, Warren Emmett, Peter Hall, Catherine Harper-Wynne, Tamas Hickish, Iain Macpherson, Alicia Okines, Andrew Wardley, Duncan Wheatley, Simon Waters, Carlo Palmieri, Matthew Winter, Rosalind J. Cutts, Isaac Garcia-Murillas, Judith Bliss, Nicholas C. Turner; Comparison of Circulating Tumor DNA Assays for Molecular Residual Disease Detection in Early-Stage Triple-Negative Breast Cancer. Clin Cancer Res 2024; https://doi.org/10.1158/1078-0432.CCR-23-2326