PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
This study, called PAveMenT, is testing a new combination of two drugs, palbociclib and avelumab, for advanced breast cancer. Specifically, it's for patients whose cancer is 'triple negative' (meaning it doesn't respond to standard hormone or HER2 treatments) and also has a marker called AR (androgen receptor). The main goals are to find the safest dose of these two drugs when used together and to see how effective this combination might be. Palbociclib is already used for another type of breast cancer, and avelumab is an immunotherapy. This research is important because the combination hasn't been tested in people before, and it could offer a new treatment option for this aggressive form of breast cancer.
At a glance
What is this study about?
This study is called PAveMenT, and it's looking into using two different drugs, palbociclib and avelumab, together for a specific type of advanced breast cancer. It's for patients whose cancer has spread or come back, and is described as either locally advanced or metastatic breast cancer. This particular study is focusing on breast cancers that are 'triple negative', meaning they don't have the usual hormone or HER2 receptors that other breast cancers might have. Instead, this study is interested in triple negative breast cancers that test positive for something called the 'androgen receptor' (AR).
Palbociclib is a drug that works by stopping cancer cells from growing and multiplying. It's already used for a common type of advanced breast cancer. Avelumab is a type of immunotherapy. This means it doesn't directly kill cancer cells, but rather encourages your body's own immune system to fight the cancer. Doctors don't yet know if combining these two drugs will be more effective than using them separately, or what the best dose for the combination is. That's why this study is so important: it's the first time these two drugs will be used together in people with cancer.
The main aims of this study are twofold. First, the researchers want to find the safest dose of palbociclib and avelumab when given together. This is a crucial step for any new drug combination. Second, once they've found the right dose, they want to see how well this combination works for patients with AR-positive triple negative breast cancer. This could potentially open up a new treatment pathway for an aggressive form of breast cancer that currently has fewer treatment options.
Key takeaways
- This study is testing a new two-drug combination for advanced breast cancer.
- It focuses on 'triple negative' breast cancer that is also 'AR positive'.
- The study aims to find the safest dose and see how well the combination works.
- One drug is an existing cancer treatment; the other is an immunotherapy.
- Participation involves regular checks and monitoring at the hospital.
Who may be eligible?
To be considered for this study, you would need to be an adult (18 years or older) with advanced breast cancer that has come back or spread, and can't be removed by surgery. You would have already received at least one, but no more than two, chemotherapy treatments for your advanced breast cancer. If your breast cancer was hormone-positive, you would also need to have received at least one hormone therapy. If it was HER2-positive, you would need to have received at least one HER2-targeted therapy.
Your doctors would also need to see if your cancer can be measured accurately, and that your blood tests (checking things like your blood cells and how your liver and kidneys are working) are within healthy ranges. These blood tests would need to be done within a week before you start the study.
If you are a woman who could still have children, you would need to have a negative pregnancy test shortly before starting the study. Both you and your male partner (if applicable) would also need to agree to use effective contraception throughout the study and for a period afterwards to prevent pregnancy.
- Are you 18 years old or older?
- Do you have breast cancer that has come back, spread, or can't be removed by surgery?
- Have you had 1 or 2 chemotherapy treatments for your advanced cancer?
- If female and able to have children, are you willing to use effective birth control?
- Are your general health and blood tests within healthy limits?
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, it actually happens in two parts. The first part will only take place at The Royal Marsden Hospital. This part focuses on finding the safest dose of the two drugs together. Any suitable patient with advanced breast cancer can join this first part.
Once the safest dose is found, the study moves to the second part. This part will involve up to eight hospitals across the UK and will focus specifically on patients with AR-positive triple negative breast cancer. Doctors will need to check your previous cancer samples to see if your cancer has this AR marker, which may mean sending your samples to a special lab.
Taking part would involve regular hospital visits for blood tests, check-ups, and to receive the study drugs. The exact number of visits and the total length of time you'll be in the study will depend on the phase you join and how your body responds to the treatment. You would be closely monitored by the study team throughout.
Potential risks and benefits
Locations (9)
- The Christie NHS Foundation TrustManchester, United Kingdom· Recruiting
- Addenbrooke's Hospital Cambridge University Hospitals NHS Foundation TrustCambridge, United Kingdom· Recruiting
- Beatson West of Scotland Cancer CentreGlasgow, United Kingdom· Recruiting
- Hope Clinical Trials Cancer CentreLeicester, United Kingdom· Recruiting
- Barts Cancer InstituteLondon, United Kingdom· Recruiting
- Royal Marsden NHS Foundation TrustLondon, United Kingdom· Recruiting
- University College London Hospitals NHS Foundation TrustLondon, United Kingdom· Recruiting
- Nottingham University HospitalNottingham, United Kingdom· Active not recruiting
- Weston Park HospitalSheffield, United Kingdom· Recruiting
Common questions
What is 'triple negative breast cancer'?
Triple negative breast cancer is a type that doesn't have the three most common 'receptors' (like switches) that doctors usually target with treatments. This means it often needs different treatment approaches.
What does 'AR positive' mean for my cancer?
AR positive means your cancer cells have a particular switch called the 'androgen receptor'. This study is looking into whether drugs that target this switch could help treat triple negative breast cancer.
Are these drugs, palbociclib and avelumab, already used for breast cancer?
Palbociclib is already used in the UK for a different type of advanced breast cancer. Avelumab is an immunotherapy drug that has been tested in breast cancer but isn't yet a standard approved treatment in the UK.
Will I get both drugs in the study?
Yes, if you join this study, you will receive both palbociclib and avelumab together, as the study aims to test this specific combination.
Why do you need to check my old cancer samples?
The second part of the study is specifically for patients whose triple negative breast cancer has the 'AR positive' marker. We'd need to check your past samples to confirm your cancer has this marker before you can join that part.
How to find out more
Orla Batchelor
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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