A phase 2 study of trifluridine/tipiracil in patients with ER-positive, HER2-negative advanced breast cancer that previously received chemotherapy (BOOG 2019-01 TIBET study)
This study is called the TIBET study and is testing a new medicine called Lonsurf (trifluridine/tipiracil) for women with advanced breast cancer. This is for a specific type of breast cancer that's called ER-positive and HER2-negative, which means it responds to hormones but not to HER2-targeted therapies. Patients in this study would have already had chemotherapy treatments like taxane and capecitabine, but their cancer has unfortunately continued to grow or come back. The main goal is to find out how many patients' cancer doesn't get worse for at least 8 weeks while taking Lonsurf. We'll also look at how long people live without their cancer growing, how many patients' cancer shrinks or disappears, their general health, and any side effects.
At a glance
What is this study about?
This study is a research project focusing on a new tablet medicine called Lonsurf. Doctors want to see how well Lonsurf works for women who have advanced breast cancer. Advanced breast cancer means the cancer has spread from where it started to other parts of the body.
The specific type of breast cancer we're looking at is called ER-positive and HER2-negative. This essentially means that the cancer cells respond to certain hormones in the body (ER-positive) but don't have a lot of a protein called HER2 (HER2-negative). This is important because it helps doctors decide which treatments might work best. The women in this study would have already tried other chemotherapy treatments, such as taxane and capecitabine, but unfortunately, their cancer has continued to grow.
The main aim of this study is to see how many patients' cancer doesn't get worse (meaning it doesn't grow or spread further) for at least 8 weeks while they are taking Lonsurf. Researchers will also be checking other important things, like how long patients live without their cancer growing at all, how many patients see their cancer shrink or disappear, their general health and quality of life, and any unwanted side effects they might experience from the treatment.
Key takeaways
- This study is for women with advanced, ER-positive, HER2-negative breast cancer.
- It's testing a new tablet medicine called Lonsurf after other chemotherapies haven't worked.
- The main goal is to see if Lonsurf stops cancer growth for at least 8 weeks.
- You would have regular check-ups and scans to monitor your health and cancer.
- Participation could help advance treatments for breast cancer, but there are potential risks and benefits.
- You must be at least 18 years old to join and a woman.
Who may be eligible?
This study is specifically designed for women who are at least 18 years old and have advanced breast cancer. It's important that you have a specific type of breast cancer known as ER-positive and HER2-negative.
You would also need to have tried other chemotherapy treatments in the past, including medicines like taxane and capecitabine, but your cancer has unfortunately continued to grow or come back.
The research team will review your medical information carefully to make sure you meet all the requirements for this study. This helps ensure the study is safe for you and that the results are clear.
- Are you a woman?
- Are you 18 years old or older?
- Do you have advanced breast cancer?
- Is your breast cancer known as ER-positive and HER2-negative?
- Have you already had chemotherapy (like taxane and capecitabine) for your breast cancer?
- Has your cancer grown or spread despite these previous treatments?
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 in this study, you would be taking Lonsurf tablets regularly. The study team will tell you the exact dose you need to take. You would have regular visits to the clinic for check-ups. These visits will involve physical exams, blood tests to check your general health, and scans to see how the cancer is responding to the treatment. You will also be asked to answer questions about your quality of life and how you are feeling.
Throughout the study, the medical team will closely monitor you for any side effects and to see how well the treatment is working. While the exact total duration isn't specified, studies like this often involve treatment for several months, with regular follow-up appointments even after you stop taking the study drug.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What kind of breast cancer is this study for?
This study is for advanced breast cancer that is ER-positive and HER2-negative, and has continued to grow despite previous chemotherapy.
What is Lonsurf?
Lonsurf is a new medicine in tablet form that this study is testing to see how well it works against advanced breast cancer.
Will I still receive my usual care if I join this study?
Yes, you will continue to receive good medical care, and you can withdraw from the study at any time without affecting your normal treatment.
What does 'progression-free at 8 weeks' mean?
It means the cancer has not grown or spread further for at least 8 weeks while taking the study medicine.
Are there any age limits for this study?
Yes, participants must be at least 18 years old. The study is open to adult women of any age over 18.
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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