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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Impact of 18F-fluoroestradiol (FES) Positron Emission Tomography (PET) on the therapeutic treatment of patients with ER+ and HER2- metastatic breast cancer in relapse after first-line therapy combining hormone therapy

This study, called a Phase IV trial, is investigating how a specific type of scan, known as a FES-PET scan, can influence the treatment choices for women with advanced breast cancer. Specifically, it's for those whose cancer has certain characteristics (ER+ and HER2-) and has come back after they've already had a first round of hormone therapy. Doctors want to understand if the information from the FES-PET scan leads to changes in the treatment plan that was originally thought of. This could involve adjusting their hormone therapy, chemotherapy, radiotherapy, or even other treatments and diagnostic tests. The main goal is to see if these scans help doctors make better decisions for patients with this type of breast cancer.

At a glance

What is this study about?

This study is trying to understand if a special type of scan, called a FES-PET scan, helps doctors make better decisions for women with a specific kind of advanced breast cancer. This cancer is known to be ER+ (meaning it responds to hormones) and HER2- (meaning it doesn't have too much of a certain protein), and it has come back after the patient has already had an initial course of hormone therapy.

The FES-PET scan looks at how much oestrogen (a hormone) is being used by the cancer cells in your body. This information can be really useful because it tells doctors if hormone therapy is likely to work well. The study aims to see if, after having this scan, doctors change the treatment they originally planned for you. This could mean trying a different hormone therapy, adding or removing other medicines, or even changing plans for radiotherapy or surgery.

Ultimately, researchers want to know if using this scan helps doctors create a more effective and personalised treatment plan for patients. They will be tracking how often treatment plans change after the scan and hope to find out if these changes lead to better outcomes for patients, like improving how long patients live without their cancer growing.

Key takeaways

  • Researchers are studying a special scan (FES-PET) for advanced breast cancer.
  • The study focuses on ER+ and HER2- breast cancer that has returned after initial hormone therapy.
  • It aims to see if the scan helps doctors make better treatment choices.
  • Changes in hormone therapy, chemotherapy, or radiotherapy might occur based on scan results.
  • Participation involves undergoing the scan and doctors recording treatment decisions.

Who may be eligible?

This study is open to women who have developed advanced breast cancer, which means it has spread to other parts of the body. Your cancer must have specific features: it needs to be 'ER positive' (which means it can be treated with hormone therapies) and 'HER2 negative' (which means it doesn't have an excess of a certain protein).

The study is for those whose breast cancer has returned or progressed after they have already completed a first course of hormone therapy. You must be at least 18 years old to take part.

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.

  1. Are you female?
  2. Are you 18 years old or older?
  3. Do you have advanced breast cancer that has spread beyond the original site?
  4. Is your breast cancer known as 'ER positive' and 'HER2 negative'?
  5. Has your breast cancer returned or progressed after you've already had a first round of hormone treatment?
Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will mainly focus on the FES-PET scan and how it influences your treatment decisions. Your doctor will first fill out a questionnaire detailing the treatment plan they had in mind for you before the scan. You will then undergo the FES-PET scan. Within two weeks after your scan, your doctor will complete another questionnaire to note any changes or adjustments made to your treatment plan based on the scan results. This could include changes to hormone therapy, chemotherapy, other systemic treatments, or radiotherapy, as well as modifications to diagnostic tests or follow-up schedules. The information is collected to see how often the scan changes planned treatments. The total duration of your participation will depend on your individual treatment plan and follow-up, but the direct assessment for the study's primary goal happens around the time of your PET-FES scan.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as the FES-PET scan could provide your doctor with additional information to help tailor your breast cancer treatment. This might lead to a more effective or personalised treatment approach for you. As with any medical procedure, there are potential risks associated with the FES-PET scan itself, such as exposure to a small amount of radiation, similar to other medical imaging scans. Your medical team will discuss these with you in detail. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Common questions

What is a FES-PET scan?

It's a special scan that helps doctors see if your cancer cells are using oestrogen, which can help guide treatment decisions for ER+ breast cancer.

Why is this scan important for my type of breast cancer?

It helps your doctor understand more about your cancer, especially if hormone therapy might still be a good option, even after your cancer has come back.

Will taking part in this study change my standard treatment?

The study is actually designed to see if the scan helps doctors decide whether to change or modify your treatment plan for the better.

What happens if the scan results lead to a new treatment plan?

Your medical team will discuss any new recommendations with you and explain why they believe it's the best approach for your health.

Is the FES-PET scan painful?

The scan itself is generally not painful, but it involves an injection of a special liquid before lying still in a scanner for a period of time.

How to find out more

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

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