Table of Contents

• Trial overview
• Who can participate
• Study design and phase
• What is being measured
• Trial setting and treatment plan

Trial overview

This article is based on one authorised trial of SILYMARIN in people with hormone receptor positive, HER2-negative breast cancer.^[1] The study is called a phase II, multicentre, open label, single arm trial.^[1] It is testing whether SILYMARIN can help prevent ribociclib-related hepatotoxicity, which means liver injury linked to ribociclib treatment.^[1]

Who can participate

The trial is designed for patients with hormone receptor positive, HER2-negative breast cancer.^[1] The brief summary says the study is focused on people receiving ribociclib plus endocrine therapy.^[1] This makes the target group very specific: breast cancer patients who are starting or receiving this treatment combination.^[1]

Study design and phase

This is an interventional study, which means the researchers are giving a treatment and then measuring the effects.^[1] It is described as open label, so the treatment is not hidden from the study team or the participants.^[1] It is also a single arm trial, meaning there is only one study group and no separate comparison group in the trial record provided.^[1] The phase is Phase 2, which usually means the study is looking more closely at whether the approach seems helpful while still monitoring safety.^[1]

What is being measured

The main endpoint, also called the primary outcome, is the incidence rate of Grade 2 or higher AST/ALT increase from the start of treatment to 6 months.^[1] AST and ALT are blood tests used to check the liver, and an increase can suggest liver irritation or injury.^[1] In simple terms, the trial wants to see how many patients develop a moderate or worse rise in these liver tests during the first 6 months.^[1]

Trial setting and treatment plan

The study is multicentre, which means it is being done at more than one site.^[1] The planned enrollment is 170 people.^[1] The intervention list includes SILYMARIN 200 mg oral tablets and Kisqali 200 mg film-coated tablets given at 600 mg by mouth.^[1] The brief summary states that the goal is to demonstrate a reduction in Grade 2 or higher AST/ALT increases during the first 6 months of ribociclib plus endocrine therapy using SILYMARIN 200 mg.^[1]