Blood tests may prevent relapse in breast cancer patients

There are currently no effective tests to establish which patients are at risk of relapse from breast cancer, so this innovative trial led by The Royal Marsden will be the first of its kind and could change how some breast cancer is treated.

A new research trial led by The Royal Marsden will look to identify risk of relapse in breast cancer patients and prevent it ever happening. The trial will use personalised blood tests to try and determine which patients will relapse, years before it’s shown on a scan. The following treatment can then be tailored to try and prevent relapse ever happening.

The trial is led by The Royal Marsden, with researchers from The Royal Marsden and The Institute of Cancer Research. It is funded by Pfizer, Invitae and Le Cure.

Trial specific lab work will take place at the Ralph Lauren Centre for Breast Cancer Research at The Royal Marsden, which was funded by supporters of The Royal Marsden Cancer Charity, including a generous donation from Ralph Lauren.

 Using blood tests (liquid biopsy) to prevent relapse in breast cancer patients

First of its kind

Patients with oestrogen receptor (ER) positive breast cancer are being recruited to a trial, named the TRAK-ER trial. They will have a blood test every three months, for up to three years, to detect their risk of cancer returning. If risk of relapse is indicated, their treatment will be altered to try and prevent relapse from happening.

The TRAK-ER trial will recruit over 1,000 patients with ER positive breast cancer who are currently receiving hormone therapy to reduce their risk of cancer returning. The trial will be rolled out to 20 UK centres over the next six months.

Principal investigator of the TRAK-ER trial, Professor Nicholas Turner

“The risk of relapse for ER positive breast cancer patients is spread out over many years after initial treatment, which is one of the reasons that scans aren't effective in trying to pick it up. Blood tests could become the standard way of following up with this group of patients, and if the trial produces encouraging results, this could revolutionise how we treat ER positive breast cancer patients in the future and hopefully save more lives.”.

Principal investigator of the TRAK-ER trial, Professor Nicholas Turner

Professor of Molecular Oncology at The Institute of Cancer Research, London, and Head of the Ralph Lauren Centre for Breast Cancer Research at The Royal Marsden NHS Foundation Trust.

How does the trial work?

Cancer cells release DNA into the bloodstream known as circulating tumour DNA (ctDNA). The blood tests used in the trial can detect very low levels of ctDNA in a blood sample, to help determine whether any cancer is present in the body.

Very low levels of cancer found in the blood indicates that the patient will eventually relapse. Therefore, testing a patient’s blood for ctDNA will allow clinicians to diagnose the return of cancer at the very earliest stage.

Previous studies have shown that ctDNA blood tests can identify relapse several months or even years before it can be seen on a scan.

 

Elaine Nangle, 41, from Reading, was diagnosed with stage three lobular breast cancer in March 2020. Following treatment she received the wonderful news that she was cancer free and was given the opportunity to join the TRAK-ER trial at The Royal Marsden. She said:

“Being part of something that may be able to give me forewarning of relapse is incredible and just knowing that I’m being monitored so frequently gives me a huge safety net. When you finish cancer treatment it’s normal to feel like your safety net has been withdrawn, so I feel extremely lucky to be part of this trial. Anything that gives me a greater chance of being here for longer, and being well for longer, is amazing.”

Elaine Nangle, part of the TRAK-ER trial

How will patients be treated?

A blood sample and tumour material from each patient’s previous breast cancer surgery will be analysed to design a personalised ctDNA test for each person on the trial. Following their blood test, if cancer is detected in a patient’s blood, but there is no evidence of cancer on scan, they will be randomly allocated one of two treatment options.

  • Group one: moved on to different drugs- palbociclib (IbranceTM) and fulvestrant (FaslodexTM)
  • Group two: hormone therapy- either a change in their standard hormone therapy or the same hormone therapy they are currently taking.

The trial will then look to see if patients treated with palbociclib and fulvestrant are less likely to relapse compared to those receiving standard hormone therapies.

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