Characteristics and Predictors of Liver Injury in Cyclin-dependent Kinase Inhibitors 4/6 (CDK4/6)-Treated Patients With Advanced Breast Cancer

Sponsor: University of Milano Bicocca
Study ID: NCT06367335
Status: Completed

Conditions

DILI

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Ribociclib, palbociclib, abemaciclib — DRUG
evaluate the presence of predictors useful to predict the development of DILI during treatment with CKI

Study Details

The main objective of the study is to evaluate the presence of predictors (single characteristics at the baseline and / or a combination of two or more parameters) useful for predicting the development of Drug-Induced liver Injury (DILI) during treatment with cyclin-dependent kinase inhibitors (CKI) with the possibility of obtaining a pre-treatment prognostic score that can assist the clinician in pre-therapy decision making.

Key Dates

Start date: Jun 1, 2022
Status verified: Apr 2024
Primary completion: Sep 1, 2022
Completion: Dec 31, 2022

Study Design

Enrollment: 128 participants (actual)

Primary Outcome Measure

Incidence of DILI [ Time Frame: 12 months ]