Phase I/II study to determine the safety and efficacy of Ribociclib in combination with hormone therapy and hypofractionated radiotherapy in breast cancer, with positive hormone receptors and negative HER2 status, in newly diagnosed, not immediately operable (or wishing to avoid surgery), elderly patient
This research study, called a Phase I/II trial, is investigating a new treatment approach for older women with a specific type of breast cancer. This cancer is sensitive to hormones and doesn't have too much of a protein called HER2. The study combines a drug called Kisqali (also known as ribociclib) with hormone therapy and a special type of radiation treatment that focuses on a smaller area (hypofractionated radiotherapy). This trial is for patients newly diagnosed who cannot have surgery right away, or who want to avoid surgery altogether. The main goals are to check how safe this combined treatment is and how well it works to stop the cancer from growing over two years.
At a glance
What is this study about?
This study is a research project designed to explore a new way of treating a particular type of breast cancer in older women. This specific cancer is known to respond to hormone treatments and doesn't involve a protein called HER2. Doctors are looking at whether combining three treatments – Kisqali (a medication), hormone therapy, and a focused type of radiation called hypofractionated radiotherapy – can be a safe and effective option.
The study is split into two main parts, Phase 1 and Phase 2. In Phase 1, the main focus is on safety. Researchers will carefully monitor how patients react to the combined treatment over the first few months, especially during the eight weeks of radiation. They want to find out what dose of the medication is safe to give alongside the other treatments without causing severe side effects.
Once the safest approach is understood, Phase 2 will then look at how well the treatment works. The main question here is how many patients still have their cancer under control 24 months after finishing the initial treatment phase. This means seeing if the cancer has not grown or spread, and if patients are still alive. Researchers will also look at the overall health and quality of life for patients taking part.
Key takeaways
- A study for older women with newly diagnosed, hormone-sensitive, HER2-negative breast cancer.
- Combines Kisqali drug, hormone therapy, and focused radiation.
- Looks at safety and how well it stops cancer growth for up to two years.
- Could be an option for those who cannot or prefer not to have immediate surgery.
- Involves regular check-ups and long-term monitoring for up to 5 years.
Who may be eligible?
This study is specifically for women who have received a new diagnosis of breast cancer. Your breast cancer must be of a type that is sensitive to hormones (meaning it has 'positive hormone receptors') and does not have too much of a protein called HER2 (meaning it is 'HER2 negative').
You would be considered for this study if you are an older patient whose cancer cannot be operated on straight away, or if you prefer not to have surgery as your initial treatment option. The study is open to adult female patients of any age.
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.
- Are you a woman who has recently been diagnosed with breast cancer?
- Is your breast cancer known to be 'hormone receptor positive'?
- Is your breast cancer known to be 'HER2 negative'?
- Is surgery not your immediate treatment option, or would you prefer to avoid it?
- Are you an older adult patient?
What does participation involve?
If you decide to take part in this study, you will receive the study medication, Kisqali, along with hormone therapy and a special type of radiation therapy. During the first few months, especially during the 8 weeks of radiation treatment, you will have regular check-ups to monitor how you are doing and to ensure the treatment is safe for you. This will involve physical examinations, blood tests, and discussions about any side effects you might experience.
After the initial treatment, you will continue to be monitored for a longer period, up to 60 months (that's 5 years). During this time, you will have further appointments to check on your health and how well the treatment is working. This will include assessments of your overall health, any ongoing side effects, and your quality of life. You'll also be asked about how regularly you're taking your medication. The exact number and frequency of visits will be explained to you by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is Kisqali (ribociclib)?
Kisqali is a medication that works by blocking certain signals in cancer cells, which can help slow down their growth. It's used in some breast cancers.
What does 'hormone-positive' breast cancer mean?
This means your cancer cells use hormones like oestrogen to grow. Hormone therapy aims to block these hormones or reduce their levels to slow down the cancer.
What is hypofractionated radiotherapy?
This is a type of radiation treatment where larger doses are given over fewer appointments, meaning a shorter overall treatment course compared to traditional radiotherapy.
How long will I be involved in the study?
You'll be closely monitored during the initial treatment phase (around 8 weeks), and then continue to have check-ups and follow-ups for up to 5 years to see how you're doing long-term.
Will this treatment cure my cancer?
This study is looking at how effective this new combination is at controlling breast cancer and preventing its progression. Medical studies can't guarantee a cure, but they help doctors find better treatments.
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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