NCT07447544

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

Predictive Factors in Primary Tumor and Liquid Biopsy for the Spread of Early Breast Cancer to the Central Nervous System

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Breast cancer is frequently diagnosed at an early stage. Despite appropriate curative treatment, a subset of patients develops distant metastases during follow-up. Metastases to the central nervous system (CNS) represent a serious clinical complication due to their significant impact on morbidity and mortality. At present, no validated blood-based biomarkers are available to reliably predict CNS dissemination in patients with early-stage breast cancer. The primary objective of this study is to identify genes that are differentially expressed in archived primary breast tumor tissue of patients who subsequently developed CNS metastases compared with matched controls who did not develop CNS metastases. Gene expression will be assessed using next-generation sequencing (NGS) of cDNA derived from mRNA. The secondary objective is to evaluate whether baseline serum concentrations of chemokines CX3CL1, CXCL13, and CXCL8 (IL-8), measured using enzyme-linked immunosorbent assay (ELISA), are associated with the later development of CNS metastases. The study includes two clinically comparable groups of patients with early-stage breast cancer: patients who developed CNS metastases during follow-up, and matched control patients without CNS metastases. Statistical analyses will include descriptive statistics, univariate and multivariate logistic regression models, and receiver operating characteristic (ROC) curve analysis to evaluate predictive performance of the investigated biomarkers.

Conditions

• Breast Cancer
• Central Nervous System Metastases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Primary Tumor mRNA Expression Profiling (NGS)	Gene expression profiling of mRNA derived from archived primary breast tumor tissue using next-generation sequencing (NGS) to identify genes differentially expressed between patients who developed CNS metastases and matched controls.
DIAGNOSTIC_TEST	Serum Chemokine Quantification (ELISA)	Measurement of serum concentrations of chemokines CX3CL1, CXCL13, and CXCL8 (IL-8) collected at diagnosis using enzyme-linked immunosorbent assay (ELISA) to evaluate their association with subsequent CNS metastases.

Timeline

• Start date: 2025-07-07
• Primary completion: 2025-12-31
• Completion: 2027-12-01
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: Slovenia