RecruitingOBSERVATIONAL

Feasibility of Serial Multisite Image-guided Biopsy to Study Breast Cancer Evolution

The FORTITUDE study wants to understand how breast cancer changes and adapts throughout treatment, particularly when it has spread (metastatic breast cancer). Currently, doctors often take one sample when cancer is first found. However, cancer can change over time and become resistant to treatments. This study will take several small tissue samples from different areas of the cancer and at different times during treatment. Researchers will also collect blood samples. By looking closely at these samples, they hope to discover how the cancer evolves. This information could lead to new ways of understanding and treating metastatic breast cancer, helping doctors choose the best treatments for patients in the future.

At a glance

Status

Recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

200

Start

23 Feb 2026

Estimated completion

01 Apr 2040

Breast Cancer Metastatic Breast Cancer Triple Negative Breast Cancer

What is this study about?

When someone has breast cancer, especially if it has spread to other parts of the body (this is called metastatic breast cancer), doctors usually take a small sample of the cancer. This sample helps them understand what kind of cancer it is and decide on the best treatment. However, cancer isn't always the same everywhere in the body, and it can also change over time, sometimes becoming resistant to treatments that used to work. This means that a single sample taken at the beginning might not tell the whole story.

The FORTITUDE study aims to get a much clearer picture of how breast cancer changes. Instead of just one sample, researchers will take several small tissue samples from different areas where the cancer is found, and they will do this at different times during treatment. This is like building a detailed timeline of how the cancer behaves. They will also collect blood samples, which can provide additional clues.

By carefully studying these samples, the research team hopes to learn how the cancer evolves, why it sometimes becomes resistant to treatment, and what makes it spread. The goal is to use this information to develop new and more effective treatments for metastatic breast cancer, and to find better ways to monitor how well treatments are working. Ultimately, this research could help doctors make more personalised and effective treatment choices for patients in the future.

Key takeaways

The FORTITUDE study investigates how metastatic breast cancer changes over time.
It involves taking multiple small tissue samples and blood tests from cancer sites.
The aim is to understand why cancer sometimes becomes resistant to treatment.
This research could help develop better, more targeted treatments in the future.
Your current medical care will not be affected by participating in this study.

Who may be eligible?

To join this study, you must be at least 18 years old and have breast cancer that has spread to other parts of your body (metastatic breast cancer) or is advanced and can't be removed by surgery. You also need to be able to understand the study and agree to take part by signing a consent form.

There are some reasons you might not be able to join. For example, if your cancer has only spread to your bones and there isn't a soft tissue part that can be sampled, or if you have a bleeding disorder that would make taking a sample unsafe. Also, if your doctor thinks the sampling procedure would be too risky for you, or if you have certain other serious health conditions like chronic infections that could put you at risk.

Finally, if you have any psychological or personal circumstances that might make it hard for you to follow the study's schedule and appointments, you might not be able to participate. The study team wants to make sure it's safe and manageable for everyone involved.

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.

Are you 18 years old or older?
Do you have breast cancer that has spread (metastatic) or is advanced and can't be operated on?
Are you able to agree to take part after understanding the study information?
Is your doctor able to take tissue samples safely without a high risk of complications?
Do you feel you would be able to attend study appointments as needed?

Answer every question to see your result.

What does participation involve?

If you join the FORTITUDE study, you will have several small tissue samples taken from your cancer, as well as blood tests. These samples will be taken from different areas where your cancer is present and at different times throughout your treatment. The study uses standard methods for taking these samples, which are similar to those used in regular care. The aim is to understand how your cancer changes over time. You'll need to attend appointments for these sample collections and any follow-up checks that are part of the study plan. The exact number of visits and the total duration will depend on your individual treatment plan and how long you are on the study. There are no new medications given as part of this study; it focuses on collecting samples to understand the cancer.

Potential risks and benefits

The main benefit of taking part in this study is that you would be contributing valuable information that could help improve future treatments for metastatic breast cancer. While this study won't directly change your current treatment, the findings could lead to better understanding and care for others. There are some potential risks associated with the sampling procedures, such as bruising, discomfort, or a small risk of infection or bleeding, similar to any biopsy. Your doctors and the study team will discuss these risks with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Royal Marsden NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a 'biopsy'?

A biopsy is when doctors take a tiny piece of tissue from your body to look at it under a microscope. This helps them understand more about your condition.

Why do you need samples from different places and at different times?

Cancer can be different in various parts of the body and can change over time. Taking samples from multiple spots and at different stages helps us get a complete picture of how the cancer behaves.

Will taking these samples affect my treatment?

No, this study is about understanding cancer, not about giving new treatments. The samples collected will be used for research, but your own doctors will continue to decide your treatment based on what's best for you.

Are there any new medicines involved in this study?

No, this study doesn't involve any new medicines. It focuses on collecting samples like tissue and blood to learn more about breast cancer.

What happens to the samples after they are collected?

The samples will be carefully studied by researchers using special tests to understand the genetic and molecular changes in the cancer. This information can help develop new treatments in the future.

How to find out more

Sophie Cooke

FORTITUDE@rmh.nhs.uk 02034373610 Official trial record

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