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

Conditions

hormone receptor positive, HER2-negative breast cancer

Brief summary

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

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGSILIMARIN 200 mg compresse rivestite

DRUGKisqali 200 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Outcome results

None listed