An open label, multi-center alpelisib roll-over study to assess long-term safety in participants who have completed a Novartis sponsored alpelisib (BYL719) study and are judged by the Investigator to benefit from continued treatment with alpelisib.
This clinical trial is designed for adults with either advanced breast cancer or a rare condition called PIK3CA-Related Overgrowth Spectrum (PROS). It is an extension study, sometimes called a 'roll-over' study. This means it is only open to people who have already taken part in an earlier trial using the medicine alpelisib. If your study doctor agrees that alpelisib has helped you and remains safe, this study allows you to keep receiving the treatment. The main goal of the research team is to check the long-term safety of alpelisib over an extended period. They will track any side effects you might experience and observe how well the treatment continues to keep your condition under control. Taking part involves attending regular hospital visits for health checks and blood tests.
At a glance
What is this study about?
This study is an extension study, often called a 'roll-over' trial. When an earlier clinical study finishes, patients who are doing well on the study medicine often need a way to continue taking it safely. This trial provides that pathway for adults who have been taking a targeted medicine called alpelisib (also known as BYL719).
Alpelisib is designed to block a specific protein in the body that can cause cells to grow too quickly. It is used to treat certain types of breast cancer, often alongside another hormone therapy called fulvestrant. It is also used to treat rare conditions grouped under the name PROS (PIK3CA-Related Overgrowth Spectrum), which cause abnormal tissue or bone growth in different parts of the body.
Because new treatments must be watched over many years, researchers want to see what happens when people stay on alpelisib for an extended time. By collecting health information over the long term, doctors can better understand potential side effects, learn how the body handles the medicine over time, and confirm whether it continues to provide steady clinical benefits to patients.
Key takeaways
- This is an extension trial for adults already taking alpelisib in a previous study.
- It helps patients with certain types of breast cancer or PROS overgrowth conditions continue treatment.
- The main aim is to check the long-term safety and ongoing benefits of the medicine.
- Your study doctor must agree that continuing the medicine is safe and helpful for you.
- Taking part is completely voluntary and you can stop at any time.
Who may be eligible?
To take part in this study, you must be 18 years of age or older. Both men and women can join.
The most important requirement is that you have already completed an earlier clinical trial for alpelisib run by the study sponsor (Novartis). This trial is not open to people who are looking to start alpelisib for the very first time.
In addition, your study doctor must review your health and decide that continuing to take alpelisib is likely to benefit you. You must also be able to tolerate the medicine safely, without any severe side effects that would make staying on it dangerous.
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.
- I am aged 18 or older.
- I have taken part in a previous clinical study testing alpelisib.
- I have completed that earlier study successfully.
- My study doctor believes I am still benefiting from taking alpelisib.
- I am able and willing to attend regular hospital check-ups.
What does participation involve?
If you join this study, you will continue taking alpelisib as prescribed by your hospital team. Depending on your condition, you may take alpelisib as daily tablets, and some breast cancer patients may also receive fulvestrant injections. You will have regular appointments at the hospital clinic so the team can monitor your health.
During your visits, you will have routine health checks. These usually include blood tests, blood pressure checks, physical examinations, and occasional scans to see how your condition is responding. You will also be asked about any symptoms or new side effects you have noticed. The study lasts for as long as your doctor believes the treatment is helping you and is safe to continue, or until you decide to stop.
Potential risks and benefits
Locations (6)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedBulgaria
- —UnverifiedSlovakia
- —UnverifiedFinland
- —UnverifiedSpain
Common questions
What is a roll-over study?
A roll-over study allows patients who finished an earlier drug trial to keep receiving the medicine so researchers can study its long-term safety.
Can I join if I have never taken alpelisib before?
No. This study is only open to people who have already completed an earlier Novartis trial testing alpelisib.
Will I have to pay for the study medicine?
No, the study medication is provided free of charge by the trial sponsor.
How long will I stay in this study?
You can usually stay in the study as long as the treatment continues to help you and does not cause troublesome side effects.
What happens if I want to stop taking part?
You are free to leave the trial at any point. Your doctors will simply discuss other suitable treatment options with you.
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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