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Enrolling by invitationOBSERVATIONAL

Pharmacogenomic and Circulating Biomarkers for CDK4/6 Inhibitors

This important research is looking into how anti-cancer medicines called kinase inhibitors affect people differently. These drugs are very helpful for various cancers, including breast cancer, but their side effects can be hard to predict. Our bodies break down many medicines using a special enzyme called CYP3A4, and how well this enzyme works can vary a lot between individuals, partly due to our genes. Currently, we don't have good ways to tell in advance who might experience unwanted side effects or whose cancer might not respond as well to these treatments. This study will examine specific genes and blood markers related to how drugs are broken down. The goal is to develop a better way to predict how someone might react to these crucial anti-cancer drugs, helping doctors choose the best and safest treatment plans.

At a glance

Status
Enrolling by invitation
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Enrolment target
100
Start
10 Oct 2025
Estimated completion
01 Sep 2028

What is this study about?

This research is looking into a really important question: why do anti-cancer medicines, especially a group called kinase inhibitors, affect people in such different ways? These drugs have brought big improvements in treating many cancers, including breast cancer. However, they can also cause side effects that are hard to predict, and sometimes they don't work as well as expected for everyone.

Our bodies have a clever system for breaking down medicines, and a key player in this system is an enzyme called CYP3A4. This enzyme is super busy, dealing with nearly half of all prescribed medications, and almost all of the kinase inhibitors used in cancer treatment. What's fascinating (and a bit challenging) is that how efficiently CYP3A4 works can vary hugely between different people – up to 400 times! This difference is often down to tiny variations in our genes.

The main goal of this study is to try and understand these differences better. Researchers will look at your genes, specifically those involved in how CYP3A4 works, and also examine certain markers in your blood. By doing this, they hope to create a clearer picture that will help doctors predict who might be more likely to experience side effects or whose treatment might not be as effective. Ultimately, this information could lead to more personalised and safer cancer treatments for everyone.

Key takeaways

  • This study aims to make breast cancer treatment with CDK4/6 inhibitors safer and more effective.
  • It looks at your genes and blood to understand why people react to medicines differently.
  • The goal is to predict who might have side effects or not respond well to treatment.
  • Your regular medical treatment will not change if you take part.
  • You would provide blood samples for genetic and other tests.

Who may be eligible?

To be considered for this study, you would need to be a woman who has been diagnosed with breast cancer. You must be over 18 years old and your doctor will need to have prescribed you a specific type of breast cancer medication called a CDK4/6 inhibitor, or be planning to prescribe it. You also need to be able to understand and speak English fluently.

There are no other specific reasons listed that would prevent you from joining this study. If you meet these simple requirements, you might be able to take part.

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.

  1. Are you a woman diagnosed with breast cancer?
  2. Are you over 18 years old?
  3. Has your doctor prescribed or discussed prescribing a CDK4/6 inhibitor for you?
  4. Can you understand and speak English well?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the research team will collect some information about your health and your breast cancer treatment. They will also need to take a blood sample from you. This blood sample will be used to look at your genes, especially those involved in how your body handles medicines, and also to measure certain markers in your blood. These measurements will help the researchers understand how your body breaks down and responds to your CDK4/6 inhibitor medication. You will continue to receive your usual CDK4/6 inhibitor treatment as prescribed by your doctor. The study will mainly involve providing these samples and information; there are no extra medications or treatments involved, and it won't change your ongoing care. The total duration of your involvement will depend on how long the researchers need to collect the necessary information and samples, but it will be explained in full detail by the study team.

Potential risks and benefits

Taking part in this study may not directly benefit you personally, but the information gained could greatly help future patients with breast cancer by leading to safer and more effective treatments. The main risk involved would be the discomfort or very small chance of bruising or infection from blood draws, which are common and usually very mild. All medical procedures carry some minimal risk. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • London Health Sciences Centre Research Institute
    Verified postcode
    London, Canada

Common questions

What is a CDK4/6 inhibitor?

It's a type of anti-cancer medicine commonly used to treat breast cancer. It works by blocking certain signals that help cancer cells grow.

What is 'CYP3A4' and why is it important?

CYP3A4 is a natural enzyme in your body that helps break down many medicines, including some breast cancer drugs. How well it works can affect how you react to your medication.

Will my treatment change if I join this study?

No, your cancer treatment with CDK4/6 inhibitors will continue exactly as your doctor has prescribed. This study won't change your medical care.

Will I find out my genetic results?

The study aims to understand general patterns. Individual results usually aren't given back to participants, but the overall findings will help improve future treatments.

How long will my involvement in the study last?

The study team will explain the exact timeframe for your participation, but it will mainly involve providing samples and information relevant to your ongoing treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Pharmacogenomic and Circulating Biomarkers for CDK4/6 Inhibi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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