2025-521651-22-00招募中2 期
Prevention of Ribociclib-related hepatotoxicity in breast cancer patients: a phase II, multicentre, open label, single arm trial of Silimarin.
Fondazione Oncotech Impresa Sociale17 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2026年2月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 17
- 主要终点
- The incidence rate of Grade ≥ 2 AST/ALT increase from the beginning of the treatment to 6 months
研究概览
简要总结
To demonstrate a reduction of Grade ≥2 AST/ALT increase in the first 6-months of Ribociclib + ET using Silimarin 200 mg.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Single Arm
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 years or older.
- •Histologically and/or cytologically confirmed diagnosis of hormone receptor positive, HER2-negative breast cancer.
- •Candidated to Ribociclib + endocrine therapy as per local guidelines.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0–
- •Adequate liver function at baseline [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be < ULN.]
- •Patients must be able to communicate with the investigator and comply with the requirements of the study procedures.
排除标准
- •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).
- •Patients are concurrently using other anti-cancer therapy, different from Ribociclib + endocrine therapy.
- •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.
- •Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels ≥ ULN, and acute or chronic hepatopathies.
- •Contraindication to ribociclib as per drug SMPC
- •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.
- •Concomitant use of CYP3A4 inducers/inhibitors
结局指标
主要结局
The incidence rate of Grade ≥ 2 AST/ALT increase from the beginning of the treatment to 6 months
The incidence rate of Grade ≥ 2 AST/ALT increase from the beginning of the treatment to 6 months
次要结局
- 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
研究者
Michelino De Laurentiis
Scientific
Fondazione Oncotech Impresa Sociale
研究点 (17)
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