c-TRAK TN
Research type
Research Study
Full title
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
IRAS ID
215068
Contact name
Nicholas Turner
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2017-000508-92
Duration of Study in the UK
5 years, 6 months, 2 days
Research summary
There is a critical clinical need to develop tests that can better identify and predict future risk of relapse (cancer returning) in patients with primary triple negative breast cancer (TNBC), to allow further treatment to be tailored to prevent or delay relapse.
DNA from cancer cells also called circulating tumour DNA (ctDNA), can be detected in the blood of cancer patients, and can be used to track progress of disease. Detection of ctDNA requires highly sensitive assays as only a small amount of cancer DNA is present in the blood. Due to technological advances personalised assays for ctDNA monitoring can be designed. ctDNA blood tests allow for highly sensitive and specific serial sampling to be performed during treatment.
Poor outcomes in TNBC patients are compounded by a lack of suitable targeted drugs. Immunotherapy is showing great promise in cancer treatment and pembrolizumab is a promising novel immune therapy in the treatment for TNBC, with evidence of activity in initial studies in metastatic TNBC patients.
This study will recruit patients who have completed, standard therapy for primary, potentially curable, TNBC. Patients will be asked to provide serial blood samples for blinded ctDNA screening. Randomisation to pembrolizumab treatment or observation will be triggered if a ctDNA test is positive, indicating that the patient still has residual cancer and is at very high risk of future relapse.
The main aims are to assess whether ctDNA screening can be used to predict which patients are at highest risk of relapse, and identify patients that have microscopic or minimal residual disease (MRD), that is not visible on imaging. Then, in patients that have MRD detected, to assess the potential effectiveness of adjuvant treatment with pembrolizumab, assessed as the ability to result in a sustained clearance of ctDNA, as a surrogate marker of effectiveness.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0090
Date of REC Opinion
9 Mar 2017
REC opinion
Favourable Opinion