Clinical trial · Observational
Characteristics and Predictors of Liver Injury in Cyclin-dependent Kinase Inhibitors 4/6 (CDK4/6)-Treated Patients With Advanced Breast Cancer
Characteristics and Predictors of Chemotherapy-induced Liver Injury in Advanced Breast Cancer Patients Treated With Cyclin-dependent Kinase Inhibitors CDK4/6
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DILI | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ribociclib, palbociclib, abemaciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of DILI
- timeFrame
- 12 months
- description
- Incidence of liver toxicity emerging on treatment, and defined according to EASL definition of drug-induced liver injury (DILI)
Secondary outcomes (2)
- measure
- withdrawal of therapy
- timeFrame
- 12 months
- description
- Proportion of patients who had to stop antineoplastic therapy due to liver injury of any grade.
- measure
- delayed reprise of antineoplastic therapy
- timeFrame
- 12 months
- description
- Time interval of therapy missed for liver toxicity issues, in days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients with advanced breast cancer (Stage IV) consecutively evaluated at the Oncology Unit of our institution and who have received at least one dose of cyclin-dependent kinase inhibitors CDK4/6 (palbociclib, ribociclib, abemaciclib) since the European Union (EU) approval date (2016, 2017, 2018) and who have been followed-up for at least three months after the administration of the last dose of drug; * Subjects willing to participate at the study data collection and aged at least 18. Exclusion Criteria: * Subjects with hepatocellular carcinoma (HCC). * Subjects with chronic active hepatitis of any cause AND/OR cirrhosis.
References
Publications (0)
Data not yet available