RecruitingPHASE2INTERVENTIONAL

A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer

This study, called TRAK-ER, aims to find out if we can detect breast cancer returning very early by looking for tiny bits of cancer DNA in the blood, called ctDNA. Many people with ER-positive, HER2-negative breast cancer are at risk of the cancer coming back, even after initial treatment. If ctDNA is found and there's no visible cancer on scans, the study will compare two treatment approaches: a new combination of medicines (Palbociclib and Fulvestrant) versus standard hormone therapy. The goal is to see if finding the cancer early and using the new treatment can delay or stop the cancer from coming back, helping patients live longer without their cancer returning.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

1,100

Start

30 Mar 2022

Estimated completion

01 Sep 2030

ER+ Breast Cancer HER2-negative Breast Cancer

What is this study about?

Many women who have been treated for a type of breast cancer called ER-positive, HER2-negative breast cancer worry about it coming back. This is a common and important concern, as this type of cancer can sometimes return years after initial treatment. Currently, doctors mainly rely on scans and symptoms to detect if the cancer has returned, but by then, it might have grown. This study hopes to find a much earlier way to spot the cancer’s return. It focuses on finding tiny traces of cancer material, called circulating tumour DNA (ctDNA), in a blood sample. These small pieces of DNA can show up in your blood even before a tumour is big enough to be seen on a scan.

TRAK-ER is a two-part study. The first part involves regular blood tests over time to look for ctDNA in people who are considered at higher risk of their cancer returning. If ctDNA is found, but scans show no visible signs of cancer, you would then be invited to the second part of the study. This second part is a treatment trial. Participants would be randomly assigned to receive either the standard hormone therapy usually given to prevent recurrence, or a new combination of two drugs, Palbociclib and Fulvestrant. Both treatments will be given for up to two years.

The main aim is to see if this new approach – finding the cancer early with a blood test and then giving the Palbociclib and Fulvestrant combination – is better at stopping or delaying the cancer from coming back compared to just continuing with standard hormone therapy. Ultimately, researchers want to find better ways to keep breast cancer from returning and to improve the long-term health of patients.

Key takeaways

Looks for early signs of breast cancer returning using blood tests.
Specifically for ER-positive, HER2-negative breast cancer patients at higher risk.
Compares standard hormone therapy with a new drug combination (Palbociclib + Fulvestrant).
Aims to delay or prevent breast cancer recurrence.
Involves regular blood tests and scans over several years.

Who may be eligible?

This study might be suitable for you if you are aged 18 or older and have been diagnosed with a specific type of breast cancer: ER-positive and HER2-negative. This means your cancer responds to hormones but lacks a certain protein called HER2. You must also not have any visible signs of the cancer spreading to other parts of your body on scans.

To join, you need to be considered at a higher risk of your breast cancer returning. This might be because the original tumour was large, involved several lymph nodes, or had certain features that doctors know mean a higher chance of recurrence. You also need to be able to continue your current hormone therapy for at least another three years.

Before taking part, doctors will check you are well enough for the study by looking at your general health. You would also need to provide tissue samples from your original cancer diagnosis and agree to regular blood and scan checks.

Quick self-check

Are you 18 years old or older?
Do you have ER-positive, HER2-negative breast cancer?
Are you currently taking hormone therapy and expect to continue for 3+ years?
Are you considered at high risk for your breast cancer returning according to your doctor?
Do you have no visible signs of cancer spreading to other parts of your body on recent scans?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the TRAK-ER study, it will involve two possible phases. In the first phase, called the surveillance phase, you would have blood tests every three months for up to three years. These tests are to check for ctDNA – tiny traces of cancer DNA. If ctDNA is found in your blood, and other scans show no visible cancer, you would then be invited to the second phase, the treatment phase.

In the treatment phase, you would be randomly assigned to one of two groups: either receiving Palbociclib tablets and Fulvestrant injections, or continuing with standard hormone therapy (like Tamoxifen, Letrozole, Exemestane, or Anastrozole). You would receive this treatment for up to two years. During this time, you would also have scans every six months to check for any visible signs of cancer. The total duration of your participation could be several years, depending on whether you enter the treatment phase and how long you remain on study.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by detecting any returning cancer earlier than usual, which might lead to more effective treatment. If you are in the treatment phase, you might receive a new combination of drugs that could be more effective at preventing recurrence. However, there are also potential risks; you might experience side effects from the study drugs, some of which could be serious. The regular blood tests and scans could also cause some anxiety. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (49)

Institut de Cancérologie de l'Ouest
Angers, France· Recruiting
Centre Hospitalier Annecy Genevois_Site d'Annecy
Annecy, France· Recruiting
Institut du Cancer Avignon Sainte Catherine
Avignon, France· Recruiting
Centre Hospitalier Simone Veil de Blois
Blois, France· Recruiting
Institut Bergonié
Bordeaux, France· Recruiting
Centre Jean Perrin
Clermont-Ferrand, France· Recruiting
Centre George François Leclerc
Dijon, France· Recruiting
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France· Recruiting
Clinique Chénieux
Limoges, France· Recruiting
Centre Hospitalier Universitaire de Limoges
Limoges, France· Recruiting
Centre Léon Bérard
Lyon, France· Recruiting
Institut Paoli Calmettes
Marseille, France· Recruiting

+37 more sites — see the official record for the full list.

Common questions

What is ctDNA?

ctDNA stands for circulating tumour DNA. It's tiny bits of genetic material from cancer cells that can be found in your blood.

What is ER-positive, HER2-negative breast cancer?

This is a common type of breast cancer where the cancer cells use hormones (like oestrogen) to grow, but they don't have high levels of a protein called HER2.

What are Palbociclib and Fulvestrant?

These are medicines used to treat breast cancer. Palbociclib is a tablet, and Fulvestrant is an injection. They work differently but both aim to stop cancer cells from growing.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctors will know which treatment you are receiving if you enter the treatment phase.

What if cancer is found on my scans?

If visible cancer is found on your scans, your study treatment would likely stop, and your doctors would discuss other standard treatment options with you.

How to find out more

Project Manager

trak-er@rmh.nhs.uk 020 7808 2887 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.