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A study to evaluate if silymarin prevents liver damage caused by ribociclib in patients with hormone receptor positive, HER2-negative breast cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with breast cancer that is specifically hormone receptor positive and HER2-negative. Some medications used to treat this type of cancer can cause hepatotoxicity, which is a term used to describe damage or injury to the liver. In this study, a drug called ribociclib is used as part of the standard treatment, and the research aims to determine if adding silymarin can help prevent liver issues during this process.

Participants in the study will take silymarin in the form of a coated tablet. The study will observe how these medications affect liver enzymes, specifically AST and ALT, which are substances measured in the blood to check for liver irritation or damage. The period of observation for these changes will take place during the first six months of treatment.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of treatment

    The treatment begins with the administration of ribociclib, which is taken as 600 mg orally, and endocrine therapy (hormonal treatment).

    Simultaneously, silymarin is taken as a 200 mg coated tablet by mouth to help prevent liver inflammation.

  2. Step 2

    First 6 months of the trial

    During the first 6 months, the focus is on monitoring liver enzymes, specifically AST and ALT. These are substances in the blood that indicate how well the liver is functioning.

    The goal is to monitor and manage any increase in these enzyme levels, which could indicate hepatotoxicity, a term used to describe liver damage or irritation caused by medication.

Who can join the trial?

6 criteria

  • You must be a man or a woman who is 18 years of age or older.
  • You must have a confirmed diagnosis of hormone receptor positive, HER2-negative breast cancer, which is a type of breast cancer that grows in response to certain hormones and does not have high levels of a specific protein called HER2.
  • You must be eligible to receive a combination of Ribociclib (a type of targeted drug) and endocrine therapy (treatment that lowers hormone levels to slow cancer growth) according to your local medical guidelines.
  • You must have an ECOG performance status of 0–2, which is a scale used by doctors to measure how well you can perform daily activities and how much your cancer affects your physical abilities.
  • You must have adequate liver function at the start of the study, meaning your levels of ALT (alanine aminotransferase) and AST (aspartate aminotransferase), which are enzymes or proteins found in the liver, must be less than the upper limit of normal.
  • You must be able to communicate with the study doctor and follow all the requirements of the study procedures.

Who cannot join the trial?

10 criteria

  • Patients who still have active or severe side effects from a previous cancer treatment that have not returned to a mild level, which is known as grade 1 or lower.
  • Patients who are currently taking any other cancer treatments besides the specific combination of Ribociclib and endocrine therapy (hormone therapy) used in this study.
  • Patients with any other serious or poorly managed medical conditions that, in the opinion of the doctor, could make participating in the study unsafe or make it difficult to follow the study rules.
  • Patients whose levels of ALT (alanine aminotransferase) or AST (aspartate aminotransferase), which are enzymes found in the liver, are higher than the upper limit of normal.
  • Patients with any hepatopathy, which is a general term for any disease or damage affecting the liver.
  • Patients who are unable to take Ribociclib based on the official medical instructions provided with the medication.
  • Patients who have an allergy or hypersensitivity (an extreme immune reaction) to the active ingredients or any of the inactive ingredients used to make Silimarin.
  • Patients who have an allergy to plants in the Asteraceae family, such as daisies or sunflowers.
  • Patients with a mechanical obstruction of the biliary ducts, which means there is a physical blockage in the tubes that carry bile from the liver to the gallbladder and intestines.
  • Patients taking any medicines that are CYP3A4 inducers or inhibitors, which are substances that speed up or slow down how the body processes certain drugs through a specific enzyme in the liver.
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Investigated drugs

  • Silymarin

    is a substance being tested to see if it can help prevent liver damage caused by other cancer treatments.

  • Ribociclib

    is a medication used as part of a treatment plan for breast cancer.

What is already known about the treatment

  • Silymarin

    This substance is taken as a tablet that you swallow by mouth. It is a natural compound widely used in herbal medicine to support liver health and protect cells from damage. It works by helping to stabilize the membranes of liver cells and promoting the regeneration of healthy tissue to prevent injury.

  • Ribociclib

    This medication is administered as a film-coated tablet that is swallowed by mouth. It is an established cancer treatment used primarily for certain types of breast cancer. It works by blocking specific proteins in cancer cells that signal them to grow and divide, effectively slowing down the progression of the disease.

Investigated diseases

Hormone receptor positive, HER2-negative breast cancer - This is a type of breast cancer where the cancer cells have receptors for hormones like estrogen or progesterone, which help the cells grow. These cells also lack an excess of a specific protein called HER2. The disease typically progresses as cells divide and spread within the breast tissue. It can also move to other parts of the body over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521651-22-00Protocol codeGIM35-RIBOSILEstimated enrolment170 patientsSponsorFondazione Oncotech Impresa Sociale

sourced from the EU Clinical Trials Register and site verification

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