SILYMARIN for Hormone receptor-positive, HER2-negative breast cancer

Inclusion criteria

• {"criterion_text":"- Men or women aged 18 years or older.\n- Histologically and/or cytologically confirmed diagnosis of hormone receptor positive, HER2-negative breast cancer.\n- Candidated to Ribociclib + endocrine therapy as per local guidelines.\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0–2.\n- Adequate liver function at baseline [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be < ULN.]\n- Patients must be able to communicate with the investigator and comply with the requirements of the study procedures."}

Exclusion criteria

• {"criterion_text":"- Patients who have not had resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤1 (except other toxicities not considered a safety risk for the patient at investigator's discretion).\n- Patients are concurrently using other anti-cancer therapy, different from Ribociclib + endocrine therapy.\n- Patients have any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol.\n- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels ≥ ULN, and acute or chronic hepatopathies.\n- Contraindication to ribociclib as per drug SMPC\n- Contraindication to Silimarin 200 mg as per drug SMPC: Hypersensitivity to the active ingredient or to any of the excipients listed; Hypersensitivity to plants of the Asteraceae (Compositae) family; Conditions of mechanical obstruction of the biliary ducts.\n- Concomitant use of CYP3A4 inducers/inhibitors"}

Primary endpoints

• {"endpoint_text":"- The incidence rate of Grade ≥ 2 AST/ALT increase from the beginning of the treatment to 6 months","definition_or_measurement_approach":"Incidence of Grade ≥2 ALT/AST increase measured from treatment start through 6 months."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Incidence of all-grade AST/ALT increases from treatment start to 6 months; comparison vs historical controls from phase III trials."}
• {"endpoint_text":"- Time to resolution of grade ≥ 2 AST/ALT increase to grade 1 or below: comparison with historical controls from phase III trials.","definition_or_measurement_approach":"Time (duration) from onset of Grade ≥2 AST/ALT increase until resolution to Grade ≤1; compared with historical controls from phase III trials."}
• {"endpoint_text":"- Time to onset of grade ≥ 2 AST/ALT increase: comparison with historical controls from phase III trials.","definition_or_measurement_approach":"Time from treatment start to first occurrence of Grade ≥2 AST/ALT increase; compared with historical controls."}
• {"endpoint_text":"- Dose intensity of Ribociclib + ET throughout the 6 months.","definition_or_measurement_approach":"Dose intensity of Ribociclib plus endocrine therapy measured over the 6-month treatment period."}
• {"endpoint_text":"- Cumulative percentage of permanent discontinuations, dose interruptions and dose adjustments during the 6 months period from the beginning of the treatment.","definition_or_measurement_approach":"Cumulative percentages of permanent discontinuations, dose interruptions and dose adjustments recorded during the 6-month period from treatment start."}
• {"endpoint_text":"- To describe differences in the management of hepatotoxicity and correlate the different strategies to time to resolution of the adverse event","definition_or_measurement_approach":"Descriptive analysis of hepatotoxicity management strategies and correlation of strategies with time to resolution of the adverse event."}

Italy

Earliest CTIS Part Ii Submission Date

11-12-2025

Latest Decision Or Authorization Date

17-02-2026

Processing Time Days

68

Number Of Sites

17

Number Of Participants

170

Primary sponsor

Full Name

Fondazione Oncotech Impresa Sociale

Organisation Type

Patient organisation/association

Country Of Registered Address

Italy

Contract research organisations

Name

Clinical Research Technology S.r.l.

Responsibilities

Sponsor duties codes: 12, 14, 15 (remote monitoring), 5, 6, 7, 8; CRO contact email: ribosil@cr-technology.com

Third parties

• {"country":"Italy","full_name":"Clinical Research Technology S.r.l.","duties_or_roles":"Sponsor duties codes present: 12, 14, 15 (remote monitoring), 5, 6, 7, 8; contact email: ribosil@cr-technology.com","organisation_type":"Pharmaceutical company"}