In short
SILYMARIN is being studied in clinical trials to see whether it can help prevent liver problems during cancer treatment. The main trial here looks at safety and effectiveness in people with hormone receptor positive, HER2-negative breast cancer who are receiving ribociclib and endocrine therapy.
Key points
- SILYMARIN is being studied in a Phase 2 trial in people with hormone receptor positive, HER2-negative breast cancer. The trial is authorised, multicentre, open label, and single arm. It plans to enroll 170 participants. The main goal is to see whether SILYMARIN can reduce Grade 2 or higher AST/ALT increases during the first 6 months of ribociclib plus endocrine therapy. The study is focused on liver safety while cancer treatment is ongoing.
Trial overview
This article is based on one authorised trial of SILYMARIN in people with hormone receptor positive, HER2-negative breast cancer. The study is called a phase II, multicentre, open label, single arm trial. It is testing whether SILYMARIN can help prevent ribociclib-related hepatotoxicity, which means liver injury linked to ribociclib treatment.
Who can participate
The trial is designed for patients with hormone receptor positive, HER2-negative breast cancer. The brief summary says the study is focused on people receiving ribociclib plus endocrine therapy. This makes the target group very specific: breast cancer patients who are starting or receiving this treatment combination.
Study design and phase
This is an interventional study, which means the researchers are giving a treatment and then measuring the effects. It is described as open label, so the treatment is not hidden from the study team or the participants. It is also a single arm trial, meaning there is only one study group and no separate comparison group in the trial record provided. The phase is Phase 2, which usually means the study is looking more closely at whether the approach seems helpful while still monitoring safety.
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. AST and ALT are blood tests used to check the liver, and an increase can suggest liver irritation or injury. 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.
Trial setting and treatment plan
The study is multicentre, which means it is being done at more than one site. The planned enrollment is 170 people. The intervention list includes SILYMARIN 200 mg oral tablets and Kisqali 200 mg film-coated tablets given at 600 mg by mouth. 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.