Prevention of Ribociclib-related hepatotoxicity in breast cancer patients: a phase II, multicentre, open label, single arm trial of Silimarin.

Condition studied

hormone receptor positive, HER2-negative breast cancer

Investigational medicinal product(s)

Every trial of Ribociclib across our registers →

Eligibility

Primary endpoint

The incidence rate of Grade ≥ 2 AST/ALT increase from the beginning of the treatment to 6 months

Endpoint detail

The incidence rate of all grade AST/ALT increases, from the beginning of the treatment to 6 months after, compared to historical controls from phase III trials, Time to resolution of grade ≥ 2 AST/ALT increase to grade 1 or below: comparison with historical controls from phase III trials., Time to onset of grade ≥ 2 AST/ALT increase: comparison with historical controls from phase III trials., Dose intensity of Ribociclib + ET throughout the 6 months., Cumulative percentage of permanent discontinuations, dose interruptions and dose adjustments during the 6 months period from the beginning of the treatment., To describe differences in the management of hepatotoxicity and correlate the different strategies to time to resolution of the adverse event