Individualized everolimus therapy in metastatic breast cancer
This study is for people with metastatic breast cancer. It's looking at how a medicine called Everolimus affects their quality of life. Participants will be divided into two groups. One group will take Everolimus as a single dose each day, while the other group will take the same total amount divided into smaller doses throughout the day. Researchers want to see if taking the medicine in smaller, divided doses improves quality of life more than a single daily dose over four months. They'll also check for side effects and how well the body uses the medicine in both groups.
At a glance
What is this study about?
This research study is for individuals living with metastatic breast cancer, which means the cancer has spread from its original site. The main goal is to understand if changing how a particular medicine, called Everolimus, is taken can improve a person's quality of life. Normally, Everolimus might be taken as one dose per day. This study wants to see if taking the same total amount of medicine, but split into smaller doses throughout the day, makes a difference.
The researchers believe that taking the medicine in divided doses might lead to a better quality of life compared to a single daily dose. Quality of life includes things like how you feel emotionally, physically, and socially. They will be using a special questionnaire called FACT-B to measure this. The study also aims to compare how well the treatment works in each group, look at any side effects people experience, and understand how the body uses the medicine with these different dosing approaches.
This is a 'Phase II' study, which means it's an important step to gather more information about how effective and safe this new way of taking Everolimus might be. It helps doctors decide if this approach should be studied further in larger trials.
Key takeaways
- The study explores different ways of taking Everolimus for metastatic breast cancer.
- It aims to see if divided doses improve quality of life more than single daily doses.
- Participants will have regular check-ups and fill out quality of life questionnaires.
- The main treatment phase lasts for four months.
- This is a Phase II study, gathering more information on treatment approaches.
Who may be eligible?
To join this study, you need to be at least 18 years old. People of all genders can take part.
More specific details about medical history, current health conditions, and previous treatments would be discussed with you by the study team to ensure the study is safe and appropriate for your individual situation.
It's important to have a conversation with your doctor or the study team to understand if you meet all the necessary requirements.
- Are you 18 years old or older?
- Have you been diagnosed with metastatic breast cancer?
- Are you able to attend regular study appointments?
- Are you able to take oral medication (pills by mouth)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be assigned to one of two groups: either receiving your Everolimus medicine as a single dose each day or as smaller, divided doses throughout the day. The treatment period is four months. Throughout this time, you will have regular visits with the study team. These visits will involve discussions about how you're feeling, checking for any side effects, and completing questionnaires like the FACT-B to assess your quality of life. You may also have blood tests to see how your body is using the medicine and for safety checks. The total duration of your participation in the study will depend on the follow-up schedule after the four-month treatment, but the main treatment phase is four months.
Potential risks and benefits
Locations (1)
- —Hungary
Common questions
What is Everolimus?
Everolimus is a medicine used to treat certain types of cancer, including metastatic breast cancer.
What does 'metastatic breast cancer' mean?
This means that the breast cancer has spread from the breast to other parts of the body.
What is 'quality of life' in this study?
It's about how you feel physically, emotionally, and socially, and how the cancer and its treatment affect your daily life. The study will use a special questionnaire to measure this.
Will I know which group I'm in?
The study team will explain whether you will know your assigned group or if it will be kept unknown to prevent bias in the results. This is something to discuss with them.
How long will the actual treatment part of the study last?
The main treatment period for this study is four months.
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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