Single arm phase II study of the efficacy and safety of the combination of Trastuzumab plus TUCAtinib plus viNorelbine in patients with HER2-positive non-resectable locally advanced or metastatic breast cancer “TrasTUCAN Study”
This study, called "TrasTUCAN," is looking at a new combination of treatments for a specific type of breast cancer. It's for people whose HER2-positive breast cancer has either spread to other parts of the body (metastatic) or cannot be surgically removed (locally advanced). The main goal is to see how many people experience their cancer shrinking or disappearing after taking Trastuzumab, Tucatinib (known as TUKYSA), and Vinorelbine together. Researchers will also check for side effects and how these medicines affect general health and quality of life. This is a Phase I and II study, meaning it's still in the earlier stages of testing how well a new treatment works and if it's safe.
At a glance
What is this study about?
This study is called the "TrasTUCAN Study" and it's researching a new way to treat a type of breast cancer called HER2-positive breast cancer. This particular study is for people whose cancer is either advanced locally (meaning it has grown into nearby tissues but cannot be fully removed by surgery) or has spread to other parts of the body (called metastatic breast cancer).
The main aim of the study is to find out how well a combination of three medicines works together. These medicines are Trastuzumab, Tucatinib (which you might know as TUKYSA), and Vinorelbine. Researchers want to see if this combination can make the cancer shrink or even disappear. They will also be closely watching for any side effects and how the treatment affects people's overall well-being and daily life. This is important to understand if the treatment is not only effective but also manageable for patients.
This study is in its early stages (Phase I and II), which means researchers are still learning a lot about this treatment. It's designed to gather important information about how safe the treatment is and how well it helps control the cancer. The information from studies like this helps doctors understand new ways to treat cancer and improve care for patients in the future.
Key takeaways
- Tests a new combination of three medicines for HER2-positive breast cancer.
- For advanced or metastatic breast cancer.
- Aims to see if it shrinks cancer and is safe.
- Includes TUKYSA tablets as part of the treatment.
- Participants will have regular check-ups and quality of life assessments.
Who may be eligible?
To be part of this study, you would need to be at least 18 years old. Both men and women can join.
The study is specifically looking for people who have HER2-positive breast cancer that has either spread to other parts of the body or is advanced locally and cannot be removed by an operation.
There will be other detailed criteria that the study doctors will check to make sure the treatment is safe and suitable for you. These can include your general health, other medical conditions you might have, and previous treatments you've received. Your doctor will discuss all of these with you carefully.
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 HER2-positive breast cancer?
- Has your cancer spread or cannot be removed by surgery?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part in this study, you would receive a combination of medicines: TUKYSA tablets (either 50 mg or 150 mg), along with Trastuzumab and Vinorelbine. The study team would carefully explain how to take these medicines.
Throughout the study, you would have regular visits to the clinic. These visits would involve various check-ups to see how you are doing, including blood tests, physical exams, and scans. These assessments help the doctors understand how your body is responding to the treatment, if the cancer is shrinking, and to monitor for any side effects.
Researchers will also ask you to fill out questionnaires about your quality of life. This helps them understand how the treatment affects your daily activities and feelings. The total length of your participation would depend on how your treatment is going and what the study doctors advise.
Potential risks and benefits
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Common questions
What kind of cancer is this study for?
This study is for HER2-positive breast cancer that has spread or can't be removed by surgery.
What medicines are being tested?
The study is testing a combination of Trastuzumab, Tucatinib (TUKYSA), and Vinorelbine.
What is the main goal of the study?
The main goal is to see how well the treatment shrinks the cancer and if it's safe.
Can women and men join this study?
Yes, both women and men who meet the other requirements can join.
What does 'Phase I and II' mean?
It means this is an earlier stage of research where doctors are still learning about the treatment's safety and how well it works.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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