A trial looking at measuring circulating tumour DNA (ctDNA) and whether it can help doctors decide when to give more treatment (c-TRAK TN)
Cancer type:
Status:
Phase:
This trial was done to find out more about levels of ctDNA after treatment for 
. It also looked at whether pembrolizumab is a useful treatment for people who have ctDNA.
The trial was open for people to join between December 2017 and December 2019. The team published the results in 2023.
More about this trial
Breast cancer cells can release small pieces of genetic material () into the bloodstream when they die. This is called circulating tumour DNA or ctDNA.
This trial was for people with triple negative breast cancer and:
- it was early stage and had not spread to another part of the body
- they had a medium to high risk that their cancer would come back
Triple negative breast cancer (TNBC) means the cancer cells don’t have receptors for:
- the hormones oestrogen and progesterone
- the protein HER2
When this trial was done, doctors usually used surgery, chemotherapy and radiotherapy to treat TNBC. They wanted to find out whether a ctDNA blood test would help to show who is more at risk of their cancer coming back. And whether pembrolizumab could be a useful treatment for this group of patients.
Pembrolizumab (Keytruda) is a type of immunotherapy. It stimulates the body’s immune system to fight cancer cells.
The research team looked for genetic changes (mutations) in everyone’s cancer cells to begin with. People who had genetic changes had blood tests every 3 months for up to 2 years. This was to look for ctDNA.
People who had ctDNA in their blood sample went into a treatment group at random. Some had pembrolizumab for up to a year, and some had standard care.
The main aims of this trial were to find out if:
- the blood test can help show who is at risk of the cancer coming back
- pembrolizumab can help stop breast cancer from coming back
Summary of results
A total of 161 people had repeated blood tests to check for ctDNA. Of these, 45 people had ctDNA in their blood. They went into one of two treatment groups.
There were:
- 32 people in the pembrolizumab group
- 13 people in the standard care group
Of the 32 people in the pembrolizumab group:
- 5 people (16%) had pembrolizumab
- 4 people (12%) decided not to have pembrolizumab
- 23 people (72%) didn’t have pembrolizumab because their cancer had already spread
The team measured the ctDNA of the 5 people who had pembrolizumab. They found that all 5 still had ctDNA in their blood samples after between 1 and 6 months of treatment.
Conclusion
The research team concluded that it was important to test for ctDNA early. This is because, in this trial, a lot of people had cancer that had already spread when they did the test. This meant that fewer people had pembrolizumab than they were expecting.
They suggest more work is done to look at:
- the best time to measure ctDNA
- using more accurate tests
- who is most likely to benefit from ctDNA tests
More detailed information
There is more information about this research in the reference below.
Please note, the article we link to here is not in plain English. It has been written for health care professionals and researchers.
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
N Turner and others
Annals of Oncology, February 2023. Volume 34, issue 2, pages 200 – 211.
Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists () and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Nicholas Turner
Supported by
Cancer Research UK
Le Cure
Merck, Sharp & Dohme
NIHR Royal Marsden Biomedical Research Centre
The Institute of Cancer Research (ICR)
The Royal Marsden NHS Foundation Trust
Other information
This is Cancer Research UK trial number CRUKE/16/024
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
