Research Scientist: Claire Swift. Budgeted cost: £65,580. Started 2018.
The c-TRAK TN trial is taking place at the Ralph Lauren Centre for Breast Cancer Research at The Royal Marsden. The trial recruited patients with moderate or high-risk triple negative breast cancer, a subtype of breast cancer that does not respond to hormone blocking drugs and is often more aggressive than most other subtypes. Eligible patients have their cancer screened for the presence of gene mutations and once they have completed their standard treatment, they have blood tests taken every 3 months to monitor for ctDNA. If relapse can be identified earlier, there may be more treatment options available, such as the use of the drug Pembrolizumab which seems to be more effective if there is only a small amount of cancer in the body.
The purpose of the c-TRAK TN trial is two-fold.
(1) To assess if a blood test can predict which patients are at highest risk of relapse by detecting tiny amounts of cancer that remain in the body, that isn’t visible through imaging.
(2) To assess the potential effectiveness of further therapy with the new drug Pembrolizumab, an immunotherapy drug which stimulates the body’s immune response to fight cancer cells.
c-TRAK TN closed for recruitment in Spring 2020. A total of 208 patients were enrolled across 17 sites within the UK. Claire completed tissue screening for 195 patients, of which 170 were shown to have mutation(s) in their cancer which could be used for tracking ctDNA in their subsequent surveillance blood samples, taken every 3 months. So far, ctDNA has been found in 28% of patients, indicating relapse. The data from this study strongly demonstrates the presence of ctDNA as a positive indicator of disease recurrence and as such, the trial protocol was amended to close the observation arm. Any patient with a subsequent ctDNA positive result detected during the active surveillance period, is given the option to commence Pembrolizumab treatment. The project is nearing completion, with final results expected in 2022.