SAFIR 03_A ctDNA screening program in patients with HR+, HER2- metastatic breast cancer for detection of high-risk relapse patients on any CDK4/6 inhibitor and a randomised phase II study comparing alpelisib combined with fulvestrant to ribociclib combined with fulvestrant, in patients with persistent targetable PIK3CA mutations.
This study is for women with a type of breast cancer called HR+, HER2- metastatic breast cancer, meaning it has spread to other parts of the body. The main goal is to find better treatments. Researchers are comparing two different drug combinations: alpelisib with fulvestrant, versus ribociclib with fulvestrant. They want to see which combination is more effective at stopping the cancer from getting worse. A key part of the study also involves using a blood test to check for certain genetic changes in the cancer and identify patients who might be at higher risk of their cancer returning while on current treatments. The hope is to improve how long people live without their cancer progressing.
At a glance
What is this study about?
This study is designed for women who have advanced breast cancer, specifically a type known as HR+, HER2- metastatic breast cancer. This means the cancer has spread beyond the original site, and its growth is driven by hormones. The 'HR+' stands for hormone receptor positive, and 'HER2-' means it doesn't have too much of a protein called HER2.
The main aim of this research is to discover more effective ways to treat this kind of breast cancer. Doctors are comparing two different drug combinations. One group of patients will receive a drug called alpelisib along with fulvestrant, while another group will receive ribociclib (which you might know as Kisqali) plus fulvestrant. All these drugs are used as hormone therapies or targeted treatments. The researchers want to find out which combination is better at stopping the cancer from growing or spreading and how long people live without their cancer getting worse.
There's also an initial part of the study that uses a special blood test. This test looks for small pieces of cancer DNA in the blood, which can help doctors identify patients whose cancer might be at a higher risk of coming back or getting worse, even while they are on their usual treatments. By understanding this sooner, doctors hope to offer more personalised and effective care.
Key takeaways
- This study explores new treatments for advanced hormone-positive, HER2-negative breast cancer.
- It compares two different drug combinations to see which is more effective.
- A blood test is used to identify patients at higher risk of their cancer progressing.
- Participation involves regular hospital visits, medications (tablets and injections), and monitoring.
- You can stop participating in the study at any time.
- The study aims to improve how long patients live without their cancer getting worse.
Who may be eligible?
This study is for adults generally aged 18 or older. It is open to both men and women.
To be considered, you must have a specific type of advanced breast cancer known as HR+ (hormone receptor positive) and HER2- (HER2 negative) that has spread to other parts of the body (metastatic).
There will be other detailed health requirements, and your doctors will check your medical history, current health, and any other medications you are taking to make sure the study is a safe and suitable option for you.
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.
- Am I at least 18 years old?
- Do I have HR+ (hormone receptor positive) breast cancer?
- Do I have HER2- (HER2 negative) breast cancer?
- Has my breast cancer spread to other parts of my body (metastatic)?
- Have I had specific genetic changes (PIK3CA mutations) found in my cancer?
- Am I willing to take part in regular hospital visits and follow study procedures?
What does participation involve?
If you decide to take part in this study, you'll first go through a screening process to make sure you meet all the requirements. This will involve various tests, possibly including blood tests and scans, to check your current health and cancer status. If you qualify and agree to participate, you would be assigned by chance (like flipping a coin) to one of the two treatment groups mentioned earlier – either alpelisib with fulvestrant or ribociclib with fulvestrant. These drugs are usually taken as tablets, and fulvestrant is an injection.
You would have regular visits to the hospital for check-ups, blood tests, and scans to monitor your health, how the treatment is working, and to manage any side effects. The exact schedule of visits and treatments would be explained to you in detail by the study team. You would continue treatment as long as it is helping to control your cancer and you are tolerating it well. After stopping the study treatment, you would likely have follow-up appointments to track your long-term health. The total duration of participation varies depending on how long the treatment works for you and the follow-up period.
Potential risks and benefits
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Common questions
What type of breast cancer is this study for?
This study is for HR+ (hormone receptor positive), HER2- (HER2 negative) metastatic breast cancer, meaning it has spread.
What drugs are being tested?
The study compares two combinations: alpelisib with fulvestrant, and ribociclib (Kisqali) with fulvestrant.
What is the main goal of the study?
The main goal is to see which drug combination best stops the cancer from growing or getting worse.
Will I get to choose which treatment I receive?
No, you would be assigned by chance (randomly) to one of the two treatment groups.
Can I leave the study at any time?
Yes, you have the right to withdraw from the study at any point without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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