Active not recruitingOBSERVATIONAL

Personalised Disease Monitoring in Metastatic Breast Cancer

This study is for people with metastatic breast cancer that's responded well to initial treatment. Currently, patients still have regular scans, but this project wants to explore if simple blood tests could offer a more personalised approach. Researchers will measure specific markers in the blood, such as circulating tumour DNA (ctDNA) and CA15-3, at the same time patients have their usual scans. The main goal is to create a tool that uses these blood test results to help doctors decide whether a scan is truly needed at a particular follow-up appointment. This could mean fewer scans for patients whose disease is stable, while still ensuring any changes are caught promptly.

At a glance

Status

Active not recruiting

Sponsor

The Christie NHS Foundation Trust

Enrolment target

Start

08 May 2019

Estimated completion

31 Jan 2030

Breast Cancer Metastatic Estrogen Receptor-positive Breast Cancer

What is this study about?

Imagine you have metastatic breast cancer and are responding well to treatment, feeling stable. Currently, you might still need regular scans every few months. While these scans are important, sometimes they show no change, making them feel a bit much. This study is all about finding a smarter, more personalised way to monitor your health.

Researchers are looking into whether certain 'markers' in your blood can give doctors useful clues about your cancer. Think of these markers like tiny biological signals. The study will measure these signals, such as circulating tumour DNA (ctDNA) and CA15-3, from blood samples taken at the same time you're having your regular scans. By comparing these blood test results with your scan results, scientists hope to develop a reliable way to predict when a scan is most likely to show a change. This could mean that if your blood markers look stable, you might be able to delay a scan, reducing the number of appointments and procedures you need.

Ultimately, the aim is to create a helpful tool for doctors. This tool would use your blood test results to recommend whether a scan is genuinely needed at a specific follow-up. This approach hopes to keep monitoring effective while making the process less burdensome for patients whose cancer is stable. It also aims to understand how much money this new monitoring method could save the healthcare system.

Key takeaways

This study explores if blood tests can help guide imaging for metastatic breast cancer.
The goal is to reduce unnecessary scans for patients with stable disease.
It aims to create a tool using blood markers to predict when a scan is most needed.
Participation involves providing extra blood samples at your regular scan appointments.
Your treatment and immediate care decisions remain based on standard guidelines.
Results could lead to more personalised and less burdensome monitoring for future patients.

Who may be eligible?

This study is looking for around 100 people who have been diagnosed with metastatic breast cancer, meaning the cancer has spread, or locally advanced breast cancer that can't be removed by surgery. Specifically, your breast cancer needs to be a type called ER-positive and HER2-negative. You should be suitable to start your first course of hormone therapy combined with a CDK4/6 inhibitor, following local guidelines.

There are a few other important points. You must be at least 18 years old and generally well enough to manage day-to-day activities with minimal help. Your cancer should be visible on scans so doctors can track it. Also, if you've had another type of cancer in the last 5 years, you'd need a biopsy of a metastatic site to confirm the breast cancer diagnosis.

You wouldn't be able to join if your cancer has spread to your brain or the lining around your brain. Also, if your breast cancer has just spread locally and could potentially be cured with surgery after treatment, this study isn't for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have metastatic (spread) or locally advanced breast cancer?
Is your breast cancer ER-positive and HER2-negative?
Are you about to start your first hormone therapy (AI) plus CDK4/6 inhibitor treatment?
Are you at least 18 years old?
Is your cancer visible and trackable on scans?
Do you not have cancer spread to your brain or its surrounding membranes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll continue to receive your usual first-line treatment for metastatic breast cancer, which includes hormone therapy (AI) plus a CDK4/6 inhibitor, as recommended by your doctor. Your regular follow-up appointments, including CT scans of your chest, abdomen, and pelvis (and possibly MRI scans if needed), will continue as planned. These scans typically happen every 3 cycles of treatment for the first year, and then every 3-4 cycles after that. The main difference is that at each of these follow-up appointments, you will also provide blood samples for the study. These blood samples will be used to measure specific markers like circulating tumour DNA (ctDNA) and CA15-3. Crucially, your doctors will still make all treatment decisions based on your routine scans and standard tests, not on the study's experimental blood marker results at the time. The study's blood tests will be analysed later to develop the new monitoring tool. You will be in the study for as long as you are on this first-line treatment and regularly having scans.

Potential risks and benefits

Taking part in this study carries potential benefits as it could help develop a more personalised way to monitor metastatic breast cancer in the future, potentially reducing the need for some scans. However, there are no direct medical benefits to you from the study's blood tests, as your treatment decisions will be based on standard care. The main extra 'risk' is the inconvenience and discomfort of additional blood draws at your regular appointments. As with any clinical trial, you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Department of Oncology, Sahlgrenska University Hospital
Verified postcode
Gothenburg, Sweden
Department of Oncology, Ryhov Hospital
Verified postcode
Jönköping, Sweden
Department of Oncology, Kalmar Hospital
Verified postcode
Kalmar, Sweden
Department of Oncology, Linköping University Hospital
Verified postcode
Linköping, Sweden
Department of Oncology, Södersjukhuset
Verified postcode
Stockholm, Sweden
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom
Wigan Infirmary, Wrightington, Wigan and Leigh NHS Foundation Trust
Verified postcode
Wigan, United Kingdom

Common questions

What is metastatic breast cancer?

Metastatic breast cancer means the cancer has spread from the breast to other parts of the body.

What are 'biomarkers'?

Biomarkers are substances in the body, like those found in blood, that can give doctors clues about your health or how your cancer is behaving.

Will my treatment change in this study?

No, you will receive your standard, doctor-recommended treatment for breast cancer. The study focuses on how you are monitored, not your medication.

Could this mean fewer scans for me?

Not directly during this study. This study aims to develop a new monitoring tool that might lead to fewer scans for patients in the future, but your scans will continue as usual for now.

What happens to the blood samples?

Your blood samples will be tested for specific markers and then stored so that scientists can also look for new markers in the future. Your personal information will be kept confidential.