SERAFA-1: A Single arm, Open label, Multicentre, Phase IIIb Study Of Camizestrant plus Ribociclib in 1st line Treatment of ER-positive, HER2-negative Advanced Breast Cancer Patients
The SERAFA-1 trial is testing a new combination of two drugs, camizestrant and ribociclib, for people with advanced ER-positive, HER2-negative breast cancer who have not yet had treatment for their advanced disease. Doctors want to see how well these medicines work together to keep cancer under control. In this study, all participants receive the same treatment combination, meaning there is no dummy pill or placebo. Researchers will track participants over two years to see how long the treatment keeps the cancer stable before another treatment is needed. They will also look closely at how safe the combination is and monitor any side effects. Taking part helps doctors learn if this new combination could offer a better first-choice option for breast cancer care in the future.
At a glance
What is this study about?
Breast cancer is often driven by hormones such as oestrogen. When cancer cells have receptors for oestrogen, it is known as ER-positive breast cancer. Standard care often involves hormone-blocking treatments combined with targeted drugs to stop cancer cells from multiplying. The SERAFA-1 study focuses on people whose breast cancer has spread or cannot be removed with surgery, and who have not yet received treatment for this stage of their illness.
This trial is testing a combination of two targeted medicines: camizestrant and ribociclib. Camizestrant works by breaking down oestrogen receptors so cancer cells struggle to grow, while ribociclib blocks key proteins that allow cancer cells to divide. Doctors hope that giving these two medicines together from the start will provide a stronger, longer-lasting effect than current options.
By taking part, participants help doctors find out whether this pair of drugs can delay the need for other treatments, such as chemotherapy, while keeping side effects manageable. The results could help shape future NHS treatment guidelines for advanced breast cancer.
Key takeaways
- Tests a new drug combination (camizestrant plus ribociclib) for advanced ER-positive, HER2-negative breast cancer.
- Aimed at people who have not yet started treatment for their advanced cancer.
- All participants receive the study medicines; there is no placebo.
- Researchers want to see if this treatment safely delays the need for other cancer therapies.
- Taking part is voluntary and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with advanced ER-positive, HER2-negative breast cancer. 'Advanced' means the cancer has spread to nearby tissue or other parts of the body and cannot be completely cleared with surgery.
To be considered, participants must be looking for their first line of treatment for this advanced stage of breast cancer. Both women and men can take part.
Because this is an early overview of the trial, your hospital team will check detailed medical criteria to ensure the study is safe for you. This includes checking your general health, organ function, and any other medications you take.
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 been diagnosed with ER-positive, HER2-negative breast cancer.
- My cancer is advanced or has spread (metastatic).
- I have not yet started treatment for this advanced stage of breast cancer.
- I am able to attend regular hospital appointments for check-ups and scans.
What does participation involve?
If you take part, you will receive both camizestrant and ribociclib as oral medications (tablets or capsules) taken according to a regular schedule. Everyone in the trial receives the study drugs, so no one receives a placebo.
You will need to visit the hospital clinic regularly, especially during the first few months. At these appointments, your care team will check your vital signs, take routine blood and urine samples, and carry out scans (such as CT or MRI scans) to see how the cancer is responding.
Doctors will follow your progress closely for at least two years. If you experience bothersome side effects, your doctor can adjust your doses or pause a medicine to keep you safe and comfortable.
Potential risks and benefits
Locations (5)
- —UnverifiedPoland
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- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedItaly
Common questions
Will I receive a placebo (dummy pill) in this study?
No. This is an 'open-label, single-arm' trial, which means every person who joins will receive the active study medications.
How long will I stay on the study treatment?
You will usually stay on the treatment for as long as it keeps your cancer stable and the side effects are manageable, or until you and your doctor decide it is best to stop.
Can men join this trial?
Yes. The trial is open to both men and women aged 18 and older who meet the medical criteria.
What happens if I get difficult side effects?
Your study team can lower your dose, pause your treatment, or treat the side effects. If necessary, you can stop taking the study drugs completely.
Do I have to pay to take part?
No. Clinical trial medicines and trial-related tests are provided free of charge, and some travel expenses may be reimbursed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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