TRAK-ER Trial and Circulating DNA Tests (ctDNA)

Hello Everyone,
I wasn’t entirely sure where to post this but here goes…
Has anyone been accepted on to the TRAK-ER trial for people who have had surgery and have a high risk of recurrence? The trial looks for blood biomarkers to assess for circulating breast cancer cells in the blood as a way of picking up any recurrence at an early stage. This is the only way to get access to this test at present unless one is accepted via a private referral and pays for the test.
It is hoped that this will one day be available on the NHS.
Also has anyone been able to have this test done privately?
I am keen to have this test as I have been told I have high risk of recurrence but am on a non-standard treatment pathway so am looking for ‘insurance’ or should that be ‘assurance!’
Best wishes Tulip xxx

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I was never told about this trial by my breast team, but I came across it whilst searching myself. I directly contacted the local investigator and got screened for eligibility and then enrolled that way. You can see the hospitals currently open to recruitment here: TRAK-ER | The Royal Marsden

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There is reddit thread documenting one person’s experience with the signatura test in the US (also a tracking test). It was pretty damn horrifying so I’ll explain why and then you can decide for yourself. Right now, the test is only experimental for breast cancer and although it can detect the cells, no one knows what to do with them when they’re found. The person in question on-line said that she tested positive and was told unequivocally that she’d have a recurrence in at most nine months time. She told her oncologist what they’d said but no one knew what to do with the info. Scans don’t detect that cells in the small amount she was positive for and without a scan confirming what the test found, no treatment could be offered. And quite honestly she was already on endocrine therapy and had been through chemo and radiation. What other treatment was there beyond that? And the cells told her nothing about where the recurrence would be found. So would in be distant, local, or even was the test wrong? Anyway no one had any answers and it was just a horrible experience. Eventually after a few months, signatura decided the cells detected were actually at a too small amount to signal a recurrence and that she was in fact negative. And thus far, no recurrence on her part either. But I would advise if you do a trial like this, find out what the protocols would be if you’d come back positive. Like is there something constructive they can actually do that would head a recurrence off? Because if not, you have to wonder what the point is.

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Hi @Tulip29
I also heard about Trak-er, and I’m very keen to find out more. I had a large tumour with LN involvement and lymphovascular invasion, so I think I would fit the criteria.
When I enquired about it in 2022, there were no participating centres in Scotland, so I was unable to get a referral. I checked your link, so I can see that’s still the case, but it looks like Glasgow & Edinburgh are possibly in the pipeline.
My thoughts were that I would prefer not to just “ wait & see”, but maybe do something more proactive, as well as possibly contribute to research.
I would be happy to travel to any centre at my own expense, or to pay for the tests.
Thanks so much for raising this, I’m also very interested in hearing the experience of others!

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Hi
I’m just adding this response so that the info will be easier to find in my list of posts rather than searching for it later.
I’m afraid I have nothing useful to add myself but will be interested to follow any further discussion so thank you, Tulip29, for kicking this off.

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Thanks to all for joining this debate. From what I have read the TRAK-ER trial does have a randomised treatment arm. I have looked into having the test privately and the cost of the test is £2,095 plus approx £750 in consultants fees etc. The trial tests every 3 months for 3 years. The trial acceptance criteria are very high. I guess one would need to weigh up the mental burden of waiting for results as opposed to just getting on with life and trying not to worry about it. Maybe @Katone you could let us know how it goes? With love to all from Tulip x

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Interesting to see the different thoughts about screening for early detection of recurrence.
My rationale for putting myself forward was that if it’s going to recur, the earlier you detect then the earlier you can start treatment and keep it at bay for as long as possible. In TRAK-ER, if they detect ctDNA then you are sent for scans to see if there is macroscopic disease (ie large enough to be visible) and if so then you are taken off trial and handed back to an oncologist for treatment. But if they can’t see anything, then you get randomised to either a new drug combination OR continue on your hormone treatment - and again the benefit is you are then monitored via scans for a number of years to see if/when secondary disease progresses and whether the new drug regimen is better or not.
I am also very keen to support research - I have a teenage daughter and if taking part in this means better monitoring and treatment in the future then I am helping her and her generation.
I have only had 2 blood tests so far and each was negative. For me, this has brought reassurance and helps me cope with the fears that niggling pains or other symptoms are recurred cancer, and that helps me get on with life. It has also been a benefit to be able to talk to an oncologist/nurses at each visit re. new symptoms or concerns.
The ‘down side’ is that it is hard going back to the oncology dept every 3 months which of course brings back memories of initial diagnosis. I also find that cancer is always on my mind whilst waiting for next test and results. But that was already the case before signing up to the trial, so I just feel like I am doing something proactive about that by taking part.
But I can completely understand that for others, such a trial may bring fears of the unknown.
It’s a large trial and so hopefully others will chip in here with their own experiences and views. But it’s also important to bear in mind that you always have a long chat with a trial clinician before deciding whether or not to take part, and of course that is the best place to get an accurate picture of what it involves and how this makes you feel.

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Hi @Katone, Thank you for explaining the process and factors to consider. I feel that it would be of great benefit to both myself and future generations to take part but my tumour was ‘only’ 2.5cm with LV1, node negative, was a HER2- tumour but HER+ at biopsy, I had to opt out of Paclitaxol and am on a nonstandard treatment pathway. To me, as someone who is basically in the wilderness it seems a good insurance policy but I fear these factors will preclude me from being allowed to take part leaving paying privately as the only viable option. Even if I went down the private route I would want the test every 6 months at least so the cost would be astronomical. It would also have to be approved by a private consultant who is effectively a gatekeeper who decides whether there is a clinical need and if not it wouldn’t be given. Tulip x

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Hi @Tulip29,
I’m really sad to hear you fell ‘below the bar’. I fell below the bar for chemo and although it’s a different matter, I understand how frustrating and upsetting cut off points can be.
Often trials start with higher risk patients as it will more quickly give them the data they need to justify utility. If successful, then they may widen the eligibility for such screening. I have just seen on the news the story about ctDNA and lung cancer - so it’s clearly an area of rapid development. Keep watching this space xx

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@Tulip29
I was not eligible for this trial as taking abemaciclib, but can enrol one year after that stops.
My alternative was not to take abemaciclib so weighing up, 1. take a medicine shown to delay/reduce recurrence or 2, dont and have test to pick up potential recurrence then take medicine at that point.
Decided to take abemaciclib and hopefully enrol in 2 years-1year after end of abemaciclib treatment.
Laura

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Similar to MistyK, I don’t have anything useful to add to this topic. But posting because I’m interested in following how you progress.

The TRAK-ER trial & circulating DNA testing was mentioned to me during my most recent oncology appointment this month, when I enquired about what methods there were available for early detection of distance recurrence (opposed it being detected late, limiting/making treatment more difficult). My Oncologist echo’ed what @Kay0987 has mentioned here about there being insufficient/no knowledge about what to do (treat/how to treat/evidence of efficacy if treated etc…) with the knowledge of circulating DNA at the moment. She also said that I wouldn’t be eligible for the TRAK-ER trial as it was only for those with a high risk of recurrence (& typically those who have had adjuvant chemo with more than 3 lymph nodes involved, but had missed out on the eligibility to start abemaciclib due to the time window that drug was approved by NICE for those with a Primary BC with high risk of recurrence).

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Hi @Tulip29 and all, I am cutrently going through the process of enrolling. I mentioned the trial to my oncology consultant who was happy to refer me and then was asked by the research team to also get a GP referral. I have an appointment later this month to go in and meet them and hopefully sign up! I had ER+ HER- breast cancer with 3cm tumour and 1 lymph node. I’ll let you know how it goes if thats helpful x

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Thanks @ali2023 for posting. I wish you well and hope your participation in the trial will be helpful and beneficial. After much thought i decided this weekend not to try and get a private ctdna test. A dear friend has just been diagnosed with spread to the lung and her symptoms were many. Her news caused me to rethink. I now feel i would rather live in ignorance than fear and if it comes back i will know. Perhaps better to get on with life rather than be tied to the hospital. My priority now is to support my friend. Sending love to all xxx

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So sorry to hear about your friend. I hope she has some good treatment options. Best wishes to you both xx

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