Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer
This study is for women with a specific type of advanced breast cancer (HR positive, HER2 negative) whose cancer has been stable for at least 12 months while taking a combination of hormone therapy and a drug called a CDK4/6 inhibitor (like Palbociclib or Abemaciclib). Researchers want to find out if it's safe for these women to stop taking the CDK4/6 inhibitor drug and just continue with their hormone therapy. The main goal is to see if their cancer remains under control for a long time even after stopping one of the medicines. This could potentially reduce side effects and improve quality of life for patients who are doing well on their current treatment regimen.
At a glance
What is this study about?
This research study is looking at advanced breast cancer, specifically the type known as HR positive, HER2 negative. This means the cancer cells have certain features that respond to hormone treatments. Many women with this type of cancer are treated with a combination of hormone therapy and a newer drug called a CDK4/6 inhibitor. These CDK4/6 inhibitors (such as Palbociclib or Abemaciclib) work by blocking certain signals that help cancer cells grow.
Usually, once you start taking these CDK4/6 inhibitors, you continue them as long as they are working and you're not experiencing too many side effects. However, this study wants to explore a different approach for women who have had great success with their treatment so far. If your cancer has been stable and well-controlled for at least 12 months on both your hormone therapy and a CDK4/6 inhibitor, the doctors want to see if you could potentially stop taking the CDK4/6 inhibitor and continue only with your hormone therapy.
The main reason for doing this is to see if your cancer remains under control for a long time even if you stop one of the medicines. If successful, this could mean fewer side effects for patients, potentially better quality of life, and could also be more cost-effective. It's a way to investigate if continued treatment with all drugs is always necessary for patients who are doing very well.
Key takeaways
- This study investigates if certain breast cancer patients can safely stop a specific medication.
- It focuses on advanced HR positive, HER2 negative breast cancer.
- You must have been treated for at least 12 months with stable cancer.
- The aim is to reduce side effects and maintain cancer control.
- Participation involves being randomly assigned to continue or stop one medication.
- Your health and cancer will be closely monitored throughout the study.
Who may be eligible?
This study is looking for women who are at least 18 years old and have advanced breast cancer that has already spread. It must be a specific type of breast cancer: hormone receptor-positive (HR+) and HER2-negative. This means the cancer responds to hormone treatments, and it doesn't have too much of a protein called HER2.
To join, you must have been taking a CDK4/6 inhibitor (like Palbociclib or Abemaciclib) along with hormone therapy for at least 12 months, and your cancer must have been stable or improving during this time. You should not have any options for curing your cancer with surgery or radiotherapy. You also need to be generally well, with good blood counts, and your liver and kidney functions need to be healthy. The study also requires you to be considered postmenopausal, which doctors define in several ways, including being over 50 with no periods for a year, or having had certain treatments that stop periods.
There are also reasons why you might not be able to join, such as having other serious health problems or if your cancer is currently getting worse. The study is very specific about who can participate to ensure it's safe and that the results are clear.
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 aged 18 or older?
- Do you have advanced HR positive, HER2 negative breast cancer?
- Have you been on a CDK4/6 inhibitor and hormone therapy for at least 12 months, with your cancer stable?
- Are you considered postmenopausal by your doctor?
- Do you have generally good health (e.g., blood counts, liver/kidney function)?
- Are there no other immediate curative treatment options for your cancer?
What does participation involve?
If you decide to take part in this study, you would first have a number of checks to make sure you are suitable. Once confirmed, you would randomly be placed into one of two groups. One group would continue taking both your CDK4/6 inhibitor and your hormone therapy, exactly as you are now. The other group would stop taking the CDK4/6 inhibitor but continue with your hormone therapy. This decision is made by chance, like flipping a coin.
After you start, you will have regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and how your cancer is responding. The doctors will closely watch for any changes in your cancer or any side effects from your treatment. The study is designed to see if your cancer remains stable over a long period. We don't have the exact duration of the study or how often visits will be, but plan for ongoing monitoring for some time. You will be fully informed about the schedule before you make any decisions.
Potential risks and benefits
Locations (13)
- Charité BerlinVerified postcodeBerlin, Germany· Recruiting
- Hämatologische Onkologische Praxis im MedicumVerified postcodeBremen, Germany· Recruiting
- St. Johannes Hospital DortmundVerified postcodeDortmund, Germany· Active not recruiting
- Praxis und TagesklinikVerified postcodeFriedrichshafen, Germany· Active not recruiting
- Hausärztliche und Onkologische GemeinschaftspraxisVerified postcodeGerlingen, Germany· Recruiting
- Onkologische GP GüterslohVerified postcodeGütersloh, Germany· Active not recruiting
- Hämatologisch-Onkologische Praxis AltonaVerified postcodeHamburg, Germany· Recruiting
- Universitätsmedizin der Johannes Gutenberg-Universität MainzVerified postcodeMainz, Germany· Recruiting
- MVZ für Hämatologie und Onkologie der MVZ Mülheim GmbHVerified postcodeMülheim, Germany· Recruiting
- MVZ für Hämatologie und OnkologieVerified postcodeRavensburg, Germany· Recruiting
- Krankenhaus Barmherzige Brüder RegensburgVerified postcodeRegensburg, Germany· Recruiting
- Onkologisch-Gastroenterologische Schwerpunktpraxis Innere Medizin GbRVerified postcodeSingen, Germany· Recruiting
Common questions
What is a CDK4/6 Inhibitor?
CDK4/6 inhibitors are medicines used to treat a specific type of breast cancer. They work by blocking signals that help cancer cells grow and divide.
Why would I stop a successful treatment?
Doctors want to see if continuing all medicines is always necessary when your cancer is already stable. Stopping one might reduce side effects while still keeping the cancer under control.
What kind of breast cancer is this study for?
This study is specifically for advanced breast cancer that is 'HR positive, HER2 negative'. This means it's a type that often responds to hormone treatments.
Will I know which treatment group I'm in?
Yes, this is an 'open-label' study, which means both you and your doctor will know whether you are continuing or stopping the CDK4/6 inhibitor.
What if my cancer gets worse?
You will be closely monitored. If your cancer shows signs of worsening, your doctors will discuss the next steps, which may include restarting the CDK4/6 inhibitor or changing to a different treatment.
How to find out more
Thomas Decker, Prof.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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