Clinical Trial

Predictive Factors for CNS Metastases in Early Breast Cancer Using Liquid Biopsy (AKRA CŽS)

Study acronym: AKRA CŽS
Active, Not Recruiting
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Summary
Breast cancer is the most common cancer in women. Although most patients are diagnosed at an early stage and treated with curative intent, some later develop metastases to the central nervous system (CNS), which are associated with poor prognosis and high morbidity. Currently, there are no validated biomarkers that reliably predict which patients with early-stage breast cancer are at increased risk for CNS metastases. This study aims to identify molecular predictors of CNS metastases in early breast cancer. Gene expression profiles (mRNA) from archived primary tumor tissue will be analyzed using next-generation sequencing (NGS). In addition, serum concentrations of chemokines CX3CL1, CXCL13, and CXCL8 (IL-8), measured at the time of diagnosis using ELISA, will be evaluated for their association with subsequent CNS metastases. The results may improve risk stratification and support earlier identification of patients at increased risk for CNS spread.
Trial Details
NCT Number NCT07447544
Lead Sponsor Institute of Oncology Ljubljana
Conditions Breast Cancer, Central Nervous System Metastases
Enrollment 22 participants
Start Date 2025-07-07
Primary Completion 2025-12-31 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-03