EPIK-B2: A two part, Phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with trastuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation
This research study, called EPIK-B2, is designed for people living with advanced HER2-positive breast cancer that also has a specific genetic change called a PIK3CA mutation. The study is testing a new drug, alpelisib, when given together with two standard treatments, trastuzumab and pertuzumab. Doctors want to find out if this new combination treatment is both safe and effective at controlling the cancer compared to receiving the standard treatments alone with a dummy drug (placebo). The study has two parts. The first part checks the safety of different doses of alpelisib in a small group. The main part of the study then compares the new treatment combination to the standard treatment plus a placebo to see if it helps patients live longer without their cancer getting worse, and to understand any side effects.
At a glance
What is this study about?
Imagine your body is like a complex machine, and sometimes parts of it, like specific genes, can develop changes that lead to diseases like cancer. In advanced HER2-positive breast cancer, we know that there's too much of a certain protein called HER2. This study looks at an additional change, a 'PIK3CA mutation', which is another common genetic change found in some breast cancers.
This research is a Phase III clinical trial, which means it's a large, important study. It's investigating a new medication called alpelisib alongside two existing, well-known cancer drugs, trastuzumab and pertuzumab. These existing drugs are already used to treat HER2-positive breast cancer. The main goal of adding alpelisib is to see if it can specifically target the PIK3CA mutation, potentially making the overall treatment more effective at controlling the cancer.
Taking part in such a study helps doctors understand if new treatments can improve outcomes for patients. It's a key step in developing better ways to fight cancer. The study is designed to be very careful, first checking the safety of the new combinations in a small group, and then, if safe, comparing the new treatment with existing ones to find out which works best and has tolerable side effects for people with this specific type of breast cancer.
Key takeaways
- This study is for advanced HER2-positive breast cancer with a specific PIK3CA gene change.
- It tests a new drug, alpelisib, combined with two standard treatments.
- The study aims to see if this new combination is safe and helps control the cancer better.
- Participants will have regular check-ups, blood tests, and scans.
- Taking part helps advance our understanding of breast cancer treatments.
Who may be eligible?
To be able to join this study, people need to be at least 18 years old. The study is open to both men and women.
Crucially, participants must have been diagnosed with advanced HER2-positive breast cancer. This means the cancer has spread beyond its original site. They also need to have a specific genetic change in their cancer cells called a PIK3CA mutation.
There might be other health conditions or treatments that could mean someone isn't suitable for the study, but these would be discussed in detail by the study doctor.
- Are you at least 18 years old?
- Do you have advanced HER2-positive breast cancer?
- Has your cancer been tested and found to have a PIK3CA gene mutation?
- Are you able to attend regular hospital appointments?
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 might receive the new drug alpelisib along with two existing cancer medications, trastuzumab and pertuzumab, or you might receive trastuzumab and pertuzumab with a dummy drug (placebo). This is decided randomly, like flipping a coin, so neither you nor your doctor will know which treatment you are getting.
Your participation will involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors will carefully track any side effects you experience. The study will continue for a period, and you'll have follow-up appointments even after treatment ends to see how you're doing in the long term. The exact number of visits and the full duration would be explained by the study team.
Potential risks and benefits
Locations (1)
- —France
Common questions
What does 'HER2-positive' mean?
HER2-positive means that your breast cancer cells have too much of a protein called HER2, which helps the cancer grow. Treatments often target this protein.
What is a 'PIK3CA mutation'?
A PIK3CA mutation is a specific change in a gene within your cancer cells. This change can sometimes make the cancer grow and may affect how it responds to certain treatments.
What is 'alpelisib'?
Alpelisib is an investigational drug being studied to see if it can help treat HER2-positive breast cancer, especially when there's also a PIK3CA gene change.
How will I know if I'm getting the new drug or a dummy drug?
This is a 'double-blind' study, meaning neither you nor your doctors will know if you are receiving alpelisib or a placebo (dummy drug). This helps ensure the study results are fair and unbiased.
What is 'advanced breast cancer'?
Advanced breast cancer, also known as metastatic breast cancer, means the cancer has spread from the breast to other parts of the body.
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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