AuthorisedTherapeutic use (Phase IV)Interventional

DOSABEMA-Pharmacokinetic model of abemaciclib: correlation with severe diarrhea as the primary toxicity endpoint in patients with hormone receptor-positive localized breast cancer

This research is investigating a common breast cancer medication called Verzenios. Specifically, it aims to understand how the drug moves through the body and how this might lead to severe diarrhoea, which is a possible side effect. The study is for women with a type of breast cancer called HR-positive, HER2-negative, which has a high chance of coming back. By carefully looking at how much of the drug is in a person's system and when side effects occur, researchers hope to build a model. This model could help doctors better predict and manage side effects like diarrhoea and another side effect called severe neutropenia (low white blood cells), ultimately helping to make treatment with Verzenios safer and more comfortable for patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire De Poitiers

Enrolment target

235

Start

06 Jan 2026

HER2- breast cancer at high risk of recurrence

What is this study about?

This study, called DOSABEMA, is looking closely at a widely used breast cancer drug called Verzenios (its scientific name is abemaciclib). The main goal is to understand how the drug works in the body and how it might cause certain common side effects, particularly severe diarrhoea. This is important because while Verzenios is effective, managing its side effects is key to ensuring patients can continue their treatment comfortably and successfully.

The researchers are focusing on women who have a specific type of breast cancer: it's called HR-positive and HER2-negative, and it's considered to be high risk, meaning there's a greater chance it could return. The study is a 'Phase IV' trial, which means the drug is already approved and in use, and this research aims to gather more detailed information about its effects in real-world patients.

By collecting data on how much of the drug is in a patient's system over time and linking this to when side effects like severe diarrhoea or low white blood cells occur, scientists can build a kind of 'map' or 'model'. This model will help them understand the connection between the drug's levels in the body and the chances of experiencing these side effects. Ultimately, this knowledge can help doctors adjust dosages or provide better advice to patients, making treatment with Verzenios safer and more effective for everyone.

Key takeaways

The study investigates how the breast cancer drug Verzenios works in the body.
It aims to link drug levels to side effects like severe diarrhoea.
It focuses on women with HR-positive, HER2-negative breast cancer at high risk.
The goal is to make Verzenios treatment safer and more predictable.
Participation involves monitoring and blood tests alongside your usual Verzenios treatment.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with a specific type of breast cancer. This breast cancer needs to be 'HR-positive' and 'HER2-negative', and it should be at a high risk of coming back after initial treatment.

Essentially, if you are an adult woman with this particular kind of breast cancer that doctors are concerned might return, you might be eligible to take part. The study is trying to understand how a specific breast cancer drug affects people like you.

There might be other specific health requirements or conditions that would prevent someone from joining, which your doctor would discuss with you in detail.

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?
Are you female?
Do you have HR-positive breast cancer?
Do you have HER2-negative breast cancer?
Has your doctor told you that your breast cancer is at a high risk of coming back?

Answer every question to see your result.

What does participation involve?

The specific details of what your participation would involve are not fully outlined in this summary. However, for similar studies, taking part typically involves regular visits to the hospital or clinic. During these visits, you would likely have blood tests taken to measure the levels of the study drug in your system. You would also be monitored closely for any side effects, particularly diarrhoea and changes in your blood count. You would continue to take Verzenios tablets as prescribed, potentially at different strengths (50mg, 100mg, or 150mg) as part of your standard care. The total duration of your participation would depend on your individual treatment plan and study requirements, but typically involves ongoing monitoring for a period.

Potential risks and benefits

Participating in research studies like this can lead to several benefits. While it may not directly change your immediate treatment, the information gathered helps improve our understanding of breast cancer treatments for future patients, potentially making them safer and more effective. You would also receive very close medical monitoring throughout the study. However, there are potential risks, mainly related to the side effects of the medication being studied, such as severe diarrhoea and low white blood cell counts, which are known side effects of Verzenios. It's crucial to remember that taking part is entirely your choice, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Verzenios?

Verzenios is a medicine used to treat a specific type of breast cancer. This study is looking at how it works in the body.

What does 'HR-positive, HER2-negative breast cancer at high risk of recurrence' mean?

This describes a specific type of breast cancer where the cancer cells grow in response to hormones (HR-positive) and do not have too much of a protein called HER2 (HER2-negative). 'High risk of recurrence' means there's a higher chance the cancer might come back.

What is 'severe diarrhoea' in this study?

Severe diarrhoea means a very significant increase in bowel movements or very loose stools. The study aims to understand how Verzenios is linked to these more serious types of diarrhoea.

Will I get a different dose of Verzenios if I join the study?

The study mentions different doses (50mg, 100mg, 150mg) of Verzenios. You would continue to receive the dose prescribed by your doctor as part of your standard care, and the study would observe its effects.

Why is this study important for people like me?

This study is important because it helps scientists understand how Verzenios affects people, allowing doctors to better manage side effects and improve treatment for patients in the future.