Study to evaluate the effect of metformin in the prevention of hyperglycemia in HR[+]/HER2[–] PIK3CA-mutated advanced breast cancer patients treated with alpelisib plus endocrine therapy. The Metallica study.
The "Metallica" study is researching a way to help people with a particular kind of advanced breast cancer. These patients have a condition where their cancer has specific features (HR-positive, HER2-negative, and a PIK3CA gene change) and are being treated with alpelisib and hormone therapy. A common side effect of alpelisib can be high blood sugar. This study wants to find out if adding metformin, a common diabetes medication, can prevent or reduce these high blood sugar levels. Researchers will closely watch patients in different groups to see how many experience serious blood sugar problems within the first 8 weeks of treatment and if treatment needs to be stopped due to side effects. The study also explores how well these treatments work overall.
At a glance
What is this study about?
This study, playfully named "Metallica," is designed for people living with a specific type of advanced breast cancer. This cancer has particular characteristics that doctors look for: it's positive for hormone receptors (HR+) and negative for HER2, and it has a change in a gene called PIK3CA. Patients with this type of cancer are often treated with a combination of medicines, including alpelisib and other hormone therapies.
One common challenge with alpelisib is that it can lead to high blood sugar levels, sometimes quite severe. High blood sugar can be uncomfortable and, in some cases, might even mean that the alpelisib treatment needs to be adjusted or stopped. This study aims to investigate whether an older, well-known medicine called metformin, which is typically used to treat diabetes, can help prevent or lessen these high blood sugar levels when taken alongside alpelisib and hormone therapy.
The main goal is to see how many patients experience very high blood sugar levels (graded as 3 or 4) within the first 8 weeks of taking alpelisib. Researchers will also look at whether patients need to stop taking alpelisib because of side effects. Additionally, the study will explore how effective the treatment combination is overall in slowing down cancer growth and how long patients respond to the treatment.
Key takeaways
- Targets advanced breast cancer (HR+/HER2-/PIK3CA-mutated).
- Investigates metformin to prevent high blood sugar from alpelisib.
- Compares different approaches to managing blood sugar during therapy.
- Aims to improve treatment tolerability and effectiveness.
- Involves regular monitoring of blood sugar and cancer progression.
Who may be eligible?
To join this study, you generally need to be at least 18 years old. Both men and women can take part. The study is specifically for people who have advanced breast cancer with certain features that doctors identify, including being HR-positive, HER2-negative, and having a specific PIK3CA gene change.
You would also need to be currently receiving or about to receive treatment with alpelisib combined with other hormone therapies for your breast cancer. The study will likely have other detailed requirements that your doctor will check to make sure it's the right fit for you.
It's important to discuss your full medical history with your doctor to see if you meet all the requirements for taking part in this particular research study.
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 at least 18 years old?
- Do you have HR+/HER2-/PIK3CA-mutated advanced breast cancer?
- Are you currently receiving or planning to start alpelisib and hormone therapy?
- Are you able to attend regular hospital visits for tests?
What does participation involve?
If you decide to take part in this study, you'll be taking part in a Phase II trial, which means it's testing a new approach or combination of existing medicines. You would receive one of several standard hormone therapy medicines along with alpelisib. Depending on which group you are in, you might also receive metformin (a tablet) or a similar-acting medicine called vildagliptin, or no extra medicine for blood sugar control.
Throughout the study, you'll have regular hospital visits for blood tests, including checks of your blood sugar levels, and other assessments to monitor your health and how the treatment is working. This will likely involve careful tracking of your blood sugar, especially during the first 8 weeks. Doctors will also check the size of your tumour to see if it's shrinking or staying stable. The exact number of visits and the full duration of your participation will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedSpain
Common questions
What is PIK3CA-mutated advanced breast cancer?
This is a specific type of advanced breast cancer where doctors have found a particular change (mutation) in a gene called PIK3CA, and it's also hormone receptor-positive and HER2-negative.
What is alpelisib?
Alpelisib is a prescribed medicine used to treat this specific type of advanced breast cancer, usually given with hormone therapy.
Why is high blood sugar a concern in this study?
High blood sugar can be a common side effect of alpelisib, and sometimes it can be severe enough to affect treatment. This study is looking for ways to manage this.
What is metformin?
Metformin is a common medicine typically used to treat type 2 diabetes by helping the body control blood sugar levels.
What does 'Phase II' mean for a clinical trial?
A Phase II trial is when researchers further test if a new treatment or approach is safe and effective, and to find the best dose, after it's shown promise in earlier stages.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.