Multicenter open-label, phase II trial, to evaluate the efficacy and safety of nal-IRI for progressing brain metastases in patients with HER2-negative breast cancer.
This research study is investigating a new medication called Onivyde for people living with HER2-negative breast cancer that has spread to the brain. This type of cancer is called metastatic breast cancer with brain metastases. The main goal is to find out how well Onivyde works at shrinking these brain tumors and to understand if it's safe for patients to take. Researchers will carefully measure changes in the size of brain tumors to see if Onivyde is effective. This trial aims to explore new treatment options for this specific group of patients, hoping to improve their care. It's a phase II study, meaning it's an important step in testing out new treatments after early safety checks.
At a glance
What is this study about?
This study is for people who have HER2-negative breast cancer that has spread to the brain. This is sometimes called 'secondary' breast cancer or 'metastatic' breast cancer. When breast cancer spreads to the brain, it can cause various symptoms and can be challenging to treat. The purpose of this trial is to investigate a new treatment called Onivyde.
The main aim of the study is to see how effective Onivyde is at shrinking brain tumors. Doctors will use special scans to measure the size of these tumors before and during the treatment. They will be looking for a 'response' – meaning the tumors get smaller or even disappear. They will also keep a close eye on any side effects to make sure the treatment is safe. The hope is that Onivyde could offer a new and effective way to manage brain metastases in patients with HER2-negative breast cancer.
This is a 'Phase II' study. This means it's one of the mid-stages of testing a new medicine. Before this, the drug would have been tested in laboratories and given to a small number of people to check its basic safety. In a Phase II study, more people take the drug, and researchers focus on whether it works well enough to be considered a valuable new treatment option, while still carefully monitoring for safety.
Key takeaways
- This study is for HER2-negative breast cancer that has spread to the brain.
- It's testing a new drug called Onivyde.
- The main aim is to see if Onivyde shrinks brain tumors and if it's safe.
- It's a Phase II study, meaning it's exploring how well the drug works.
- Regular scans and health checks will be part of the trial.
- You can discuss with your doctor if this trial is right for you.
Who may be eligible?
To join this study, suitable participants must be at least 18 years old. The study is open to both men and women.
Key conditions for joining are that you must have HER2-negative breast cancer that has spread to your brain. This means the cancer in your brain must be 'measurable' (doctors can see and measure the size of the tumors on scans) and must have recently grown or progressed.
It's important that your overall health is good enough to take part in a clinical trial. There will be other specific medical checks to make sure the study is a safe and appropriate option for you.
- Are you at least 18 years old?
- Do you have HER2-negative breast cancer?
- Has your breast cancer spread to your brain?
- Have your brain tumors grown recently?
- Are your brain tumors measurable on scans?
- Are you generally well enough to participate in a study?
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 receive the study medication, Onivyde, through a drip (infusion). How often these infusions happen and for how long will be explained in detail by the study team. You would have regular appointments at the hospital or clinic. During these visits, the study team would monitor your health closely, which would include physical exams, blood tests, and brain scans (like an MRI or CT scan) to check how the treatment affects your tumors and to look for any side effects.
There will also be assessments to understand how you are feeling generally and if your symptoms are changing. You will need to tell the study team about any changes in your health or any new symptoms you experience. The total duration of your participation in the study, including the treatment period and any follow-up visits, will be clearly explained to you before you agree to join.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What does 'HER2-negative' mean?
HER2-negative is a type of breast cancer where the cancer cells do not have a lot of a protein called HER2. This affects which treatments might work best for you.
What are 'brain metastases'?
Brain metastases means that your breast cancer has spread from your breast to your brain, forming new tumors there.
What is Onivyde?
Onivyde is the name of the new medication being tested in this study. It's a type of chemotherapy that is packaged in tiny fatty bubbles so it can get to the cancer cells effectively.
What is a 'Phase II trial'?
A Phase II trial is a stage of research where doctors test a new treatment on a larger group of people to see how well it works and to continue monitoring its safety.
Will I know if the treatment is working?
Yes, doctors will use regular brain scans to measure your tumors. They will discuss the results with you to see if the treatment is shrinking them or if they are stable.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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