Not yet recruitingNAINTERVENTIONAL

Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME)

This study, called TDHOME, is for people with breast cancer who are taking specific medicines called CDK4/6 inhibitors (like ribociclib, abemaciclib, or palbociclib). These medicines can sometimes have side effects, and checking how much medicine is in your body can help doctors find the best dose for you. Usually, this means blood tests where a needle is put into a vein in your arm, which can be uncomfortable, especially if done often. This study is testing a new, much simpler way to check medicine levels – using small blood samples taken from a finger-prick. This is called 'capillary microsampling'. The goal is to see if these finger-prick samples are just as accurate as the traditional arm blood tests. If they are, it could mean easier and more convenient monitoring for patients in the future, possibly even at home.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Institut Curie

Enrolment target

Start

15 May 2026

Estimated completion

15 Dec 2028

Breast Cancer

What is this study about?

When you're taking medicine for breast cancer, especially drugs like ribociclib, abemaciclib, or palbociclib (which are called CDK4/6 inhibitors), it's important to make sure you're getting the right amount. Too little medicine might mean it's not working as well, and too much could lead to more side effects. Doctors sometimes check the level of medicine in your blood to help them adjust your dose and make sure you're getting the best possible treatment with the fewest problems. This is known as 'therapeutic drug monitoring'.

Currently, checking these medicine levels usually involves taking blood from a vein in your arm, which can be uncomfortable or difficult, especially if you need tests often. This study is exploring a much simpler alternative: taking tiny blood samples from a finger-prick, similar to how people with diabetes check their blood sugar. This method is called 'capillary microsampling' and uses a small device.

The main idea behind this study is to see if these finger-prick blood samples give the same reliable information about your medicine levels as the usual blood tests taken from your arm. If they do, it could mean that in the future, you might be able to check your medicine levels more easily and comfortably, perhaps even at home, rather than always having to go to a clinic for a traditional blood test. This could make your treatment journey a bit easier.

Key takeaways

This study is for breast cancer patients taking specific modern medications.
It's testing a simpler finger-prick blood test instead of traditional arm blood tests.
The aim is to make medicine level monitoring easier for patients.
Participation involves one blood sample collection session.
Your routine breast cancer treatment will not change.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have breast cancer. You must currently be taking one of the following specific breast cancer medications: ribociclib, abemaciclib, or palbociclib.

It's important that you or someone helping you can take the finger-prick blood samples. You also need to understand what the study involves and agree to take part by signing a consent form. Finally, you need to be able to follow the study instructions and have health insurance.

You cannot join the study if you have a serious mental health condition that would prevent you from understanding and agreeing to take part properly, or if you are in prison or under legal guardianship.

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 18 years old or older?
Do you have breast cancer?
Are you currently taking ribociclib, abemaciclib, or palbociclib?
Are you able to take finger-prick blood samples yourself, or with help?
Do you have a health insurance system and can follow study instructions?

Answer every question to see your result.

What does participation involve?

If you take part, you'll have one study visit during your usual treatment. During this visit, a nurse will collect five blood samples from you. Four of these will be small finger-prick samples using a special device. The nurse will collect two of these finger-prick samples and then show you how to collect the other two yourself. You'll also have one standard blood sample taken from a vein in your arm. Your regular breast cancer treatment with CDK4/6 inhibitors will continue exactly as prescribed by your doctor throughout the study. There are no additional treatments or follow-up visits specifically for this study beyond this one collection point.

Potential risks and benefits

Participating in this study might offer the benefit of contributing to research that could make future blood testing for breast cancer medications much easier and more convenient for patients. You won't directly receive extra medical benefits from taking part, as your medication and care will continue as usual. The main risks are minor discomfort or a small bruise from the finger-pricks or the arm blood test. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Institut Curie Paris
Verified postcode
Paris, France
Institut Curie
Verified postcode
Saint-Cloud, France

Common questions

What is a CDK4/6 inhibitor?

CDK4/6 inhibitors are a type of medicine used to treat breast cancer. Examples include ribociclib, abemaciclib, and palbociclib.

What is 'therapeutic drug monitoring'?

This is when doctors measure the amount of medicine in your blood to make sure you're getting the best dose for you and to help manage side effects.

What is a 'capillary sample'?

A capillary sample is a tiny blood sample taken from a finger-prick, similar to how you might check blood sugar levels.

Will this study change my breast cancer treatment?

No, your breast cancer treatment will continue exactly as your doctor has prescribed. This study is only about testing a new way to take blood samples.

How many times will I have to give blood?

You will provide five blood samples (four finger-prick, one arm vein) at a single time point during your regular treatment.

How to find out more

Marie-Emmanuelle Legrier

drci.promotion@curie.fr 0033156245649 Official trial record

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