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AuthorisedTherapeutic exploratory (Phase II)Interventional

Radium223 dichloride (223RaCl) in the treatment of symptomatic bone metastases from breast cancer.

This research study is for women who have breast cancer that has spread to their bones and is causing pain. It's investigating a medicine called Radium-223 dichloride (sometimes shortened to Radium-223). The main goals are to find out if Radium-223 can help stop the cancer from getting worse for longer, ease bone pain, and make a real difference to how well people feel the quality of their life. Researchers also want to see if it helps people live longer and reduces other bone-related problems. This is an early-stage study, meaning it's one of the first times this treatment is being looked at for this specific situation.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Enrolment target
50
Start
08 Jun 2026

What is this study about?

This study is looking into a new treatment called Radium-223 dichloride for women who have breast cancer that has spread to their bones. When breast cancer spreads to the bones, it can cause pain and other difficulties. The aim of this research is to see if Radium-223 can be a helpful option to manage this situation.

The researchers want to understand if this treatment can slow down the cancer's progression, meaning how quickly it might grow or spread further. They are also very interested in whether it can help reduce the pain caused by cancer in the bones, which is a big concern for many patients. On top of that, improving a person's quality of life – how well they feel and their overall well-being – is a key focus.

While the main goals are about slowing cancer growth, reducing pain, and improving quality of life, the study will also look at other important things. This includes how long people live overall, whether the treatment helps avoid other bone problems, and how it affects certain markers in the blood. The results from this study will help doctors understand more about how best to treat breast cancer that has spread to the bones.

Key takeaways

  • This study is for women with breast cancer that has spread to their bones and is causing pain.
  • It's testing a new treatment called Radium-223 dichloride.
  • The main goals are to relieve pain, slow cancer growth, and improve your quality of life.
  • You will be closely monitored by doctors and nurses if you take part.
  • Participation involves regular visits and health checks.
  • You can stop participating at any time.

Who may be eligible?

This study is designed for women who are at least 18 years old and have breast cancer that has spread to their bones and is causing symptoms, such as pain. You would need to have specific medical records and health conditions that match the study requirements.

Before joining, doctors will carefully check your medical history, current health, and specific breast cancer details to make sure this study is right and safe for you. This includes reviewing any previous treatments you may have had for your cancer.

There might be other health conditions or medications that would prevent you from taking part, to ensure your safety. Your doctor will discuss all these details with you thoroughly if you are interested in participating.

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 breast cancer that has spread to your bones?
  4. Is this bone spread causing you symptoms, like pain?
  5. Are you able to attend regular clinic appointments for treatment and check-ups?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would begin by signing a consent form after having all your questions answered. This confirms you understand what's involved. You would then receive either Radium-223 dichloride or one of the other standard hormone therapies (Exemestane, Letrozole, or Anastrozole), depending on what the study doctors decide is best for your situation.

Participation would involve regular visits to the hospital or clinic. During these visits, doctors and nurses would perform various assessments. This might include blood tests, scans (like X-rays or bone scans) to check on your cancer, physical exams, and questionnaires about your pain levels and general well-being. These checks are important to see how the treatment is working and to monitor your health.

The duration of your participation in the study will depend on how your cancer responds to the treatment and your overall health. You will continue to be monitored even after the main treatment phase, to track how you are doing over a longer period. The total length of follow-up can vary for each person.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new treatment that might help your condition, as well as close monitoring of your health by a team of experts. However, there are also potential risks involved, including possible side effects from the treatments that might be uncomfortable or, in rare cases, serious. The treatments being tested, like any medicine, can have side effects. You will be given detailed information about any known side effects. 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 (1)

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

Common questions

What is Radium-223 dichloride?

It's a type of medicine being studied for breast cancer that has spread to the bones. It targets areas in the bones where cancer has spread.

What does 'bone metastases' mean?

It means the breast cancer has spread from its original site to your bones. This can sometimes cause pain and other problems.

What does 'quality of life' mean in this study?

It refers to how well you feel generally, your comfort, and your ability to carry out daily activities. The study aims to improve this.

Will I definitely receive Radium-223 in this study?

You might receive Radium-223 or one of the other standard hormone therapies for breast cancer, such as Exemestane, Letrozole, or Anastrozole. The specific treatment you receive will be decided by the study doctors.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your standard medical care.

How to find out more

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

Discussion

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