AuthorisedTherapeutic exploratory (Phase II)Interventional

Prevention of Ribociclib-related hepatotoxicity in breast cancer patients: a phase II, multicentre, open label, single arm trial of Silimarin.

This study is for people with a specific type of breast cancer (hormone receptor positive, HER2-negative) who are taking the medicine Ribociclib. Ribociclib can sometimes cause liver problems. This study is testing whether a natural product called Silymarin, given as tablets, can help reduce or prevent these liver problems. Researchers will carefully watch participants for six months to see how many develop liver enzyme changes. They will also compare their findings to information from previous large studies to understand if Silymarin makes a difference. The goal is to find ways to make Ribociclib treatment safer and easier for patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Oncotech Impresa Sociale

Enrolment target

170

Start

17 Feb 2026

hormone receptor positive HER2-negative breast cancer

What is this study about?

This study is looking into a way to help reduce a common side effect for people taking a breast cancer medicine called Ribociclib (also known as Kisqali). Ribociclib is used to treat a specific type of breast cancer that is hormone receptor positive and HER2-negative. While Ribociclib is an effective treatment, it can sometimes cause changes in the liver, which doctors monitor by checking liver enzyme levels in the blood.

Researchers want to see if a natural product called Silymarin, which comes from milk thistle, can help protect the liver from these potential side effects. Participants in this study will take Silymarin tablets alongside their usual Ribociclib treatment. The main aim is to see how many people develop noticeable liver enzyme changes over six months when taking Silymarin, and then compare this to information from previous similar studies where Silymarin was not given.

By carefully tracking liver enzyme levels and how any liver changes are managed, this study hopes to find out if Silymarin can make Ribociclib treatment safer and more manageable. If successful, this could mean fewer interruptions or dose changes to Ribociclib, allowing patients to stay on their cancer treatment more consistently.

Key takeaways

This study investigates if Silymarin can prevent liver side effects from Ribociclib.
It's for people with a specific type of breast cancer (hormone receptor positive, HER2-negative).
Looks at liver enzyme changes over six months.
Compares results to what is known from previous large studies.
Aims to make Ribociclib treatment safer and reduce treatment interruptions.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. There is no upper age limit for taking part.

You must have been diagnosed with a specific type of breast cancer. This is known as 'hormone receptor positive' and 'HER2-negative' breast cancer.

Your medical team will check other health details to make sure this study is safe and right for you. They will confirm if you meet all the necessary requirements to participate.

Quick self-check

Are you 18 years old or older?
Do you have hormone receptor positive, HER2-negative breast cancer?
Are you currently taking or about to start Ribociclib (Kisqali)?
Are you willing to take Silymarin tablets as part of the study?
Are you able to attend regular hospital visits for blood tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will take Silymarin tablets alongside your regular Ribociclib medication. You'll have regular hospital visits for blood tests to check your liver function and overall health. These visits will likely happen at the beginning of the study and then at regular intervals over a six-month period. Your doctors will explain the exact schedule of visits and tests. The total duration of active participation and monitoring for the main part of this study will be six months.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if Silymarin helps reduce liver side effects from Ribociclib, making your treatment more tolerable. However, like all medicines, Silymarin could have its own side effects, although it's generally considered safe. There's also no guarantee that Silymarin will work for everyone or that you won't experience liver changes. You always have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

—
Italy

Common questions

What is Ribociclib?

Ribociclib is a medicine used to treat a specific type of advanced breast cancer.

What are 'liver enzymes' and why are they checked?

Liver enzymes are substances in your blood. High levels can sometimes be a sign of liver stress or damage, so doctors check them to monitor liver health.

What is Silymarin?

Silymarin is a natural substance extracted from the milk thistle plant, often used to support liver health.

Will I still get my usual cancer treatment?

Yes, you will continue to receive your Ribociclib treatment as prescribed, and the Silymarin will be taken alongside it.

How long will the study last for me?

Your active participation in the study, including monitoring for liver changes, will last for six months.