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Prevention of Ribociclib-related hepatotoxicity in breast cancer patients: a phase II, multicentre, open label, single arm trial of Silimarin
EU CTIS ID: 2025-521651-22-00
What this study is testing
To demonstrate a reduction of Grade ≥2 AST/ALT increase in the first 6-months of Ribociclib + ET using Silimarin 200 mg.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men or women aged 18 years or older.
- Histologically and/or cytologically confirmed diagnosis of hormone receptor positive, HER2-negative breast cancer.
- Candidated to Ribociclib + endocrine therapy as per local guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0–2.
- Adequate liver function at baseline [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be < ULN.]
- Patients must be able to communicate with the investigator and comply with the requirements of the study procedures.
You likely can't join if
- Patients who have not had resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤1 (except other toxicities not considered a safety risk for the patient at investigator's discretion).
- Patients are concurrently using other anti-cancer therapy, different from Ribociclib + endocrine therapy.
- Patients have any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol.
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels ≥ ULN, and acute or chronic hepatopathies.
- Contraindication to ribociclib as per drug SMPC
- Contraindication to Silimarin 200 mg as per drug SMPC: Hypersensitivity to the active ingredient or to any of the excipients listed; Hypersensitivity to plants of the Asteraceae (Compositae) family; Conditions of mechanical obstruction of the biliary ducts.
See the full eligibility criteria
- Men or women aged 18 years or older.
- Histologically and/or cytologically confirmed diagnosis of hormone receptor positive, HER2-negative breast cancer.
- Candidated to Ribociclib + endocrine therapy as per local guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0–2.
- Adequate liver function at baseline [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be < ULN.]
- Patients must be able to communicate with the investigator and comply with the requirements of the study procedures.
- Patients who have not had resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤1 (except other toxicities not considered a safety risk for the patient at investigator's discretion).
- Patients are concurrently using other anti-cancer therapy, different from Ribociclib + endocrine therapy.
- Patients have any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol.
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels ≥ ULN, and acute or chronic hepatopathies.
- Contraindication to ribociclib as per drug SMPC
- Contraindication to Silimarin 200 mg as per drug SMPC: Hypersensitivity to the active ingredient or to any of the excipients listed; Hypersensitivity to plants of the Asteraceae (Compositae) family; Conditions of mechanical obstruction of the biliary ducts.
- Concomitant use of CYP3A4 inducers/inhibitors
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.