Breast CancerAKRA CŽSNCT07447544
Predictive Factors for CNS Metastases in Early Breast Cancer Using Liquid Biopsy (AKRA CŽS)
A study testing Primary Tumor mRNA Expression Profiling (NGS) and Serum Chemokine Quantification (ELISA) in people with Breast Cancer and Central Nervous System Metastases, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Central Nervous System Metastases
- What is being tested?
- Primary Tumor mRNA Expression Profiling (NGS) and Serum Chemokine Quantification (ELISA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSlovenia
- Study dates
- 7 Jul 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older.
- Diagnosis of early-stage breast cancer.
- Availability of archived primary tumor tissue suitable for mRNA analysis.
- Availability of serum sample suitable for chemokine analysis.
- Patients included in the AKRA cohort with documented follow-up data.
- Patients with confirmed CNS metastases during follow-up (CNS metastases group) or matched controls without CNS metastases (control group).
Who cannot join
- Male breast cancer patients.
- Lack of sufficient primary tumor tissue for mRNA analysis.
- Lack of available serum sample for chemokine analysis.
- Incomplete clinical follow-up data preventing classification of CNS metastasis status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors in Primary Tumor and Liquid Biopsy for the Spread of Early Breast Cancer to the Central Nervous System
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.
Read the 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
- Being tested
- Primary Tumor mRNA Expression Profiling (NGS), Serum Chemokine Quantification (ELISA)
- Keywords
- early-stage breast cancer, molecular biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Tumor mRNA Expression Profiling (NGS)Diagnostic test
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.
Serum Chemokine Quantification (ELISA)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| CNS Metastases Group | Experimental | Female patients with early-stage breast cancer who developed central nervous system (CNS) metastases during follow-up. Participants undergo molecular biomarker assessment consisting of primary tumor mRNA gene expression profiling using next-generation sequencing (NGS) and measurement of baseline serum chemokine concentrations (CX3CL1, CXCL13, CXCL8 [IL-8]) using ELISA. Receives: Diagnostic Test: Primary Tumor mRNA Expression Profiling (NGS); Diagnostic Test: Serum Chemokine Quantification (ELISA) |
| Control Group (No CNS Metastases) | Active comparator | Matched female patients with early-stage breast cancer who did not develop CNS metastases during follow-up. Participants undergo molecular biomarker assessment consisting of primary tumor mRNA gene expression profiling using next-generation sequencing (NGS) and measurement of baseline serum chemokine concentrations (CX3CL1, CXCL13, CXCL8 [IL-8]) using ELISA. Receives: Diagnostic Test: Primary Tumor mRNA Expression Profiling (NGS); Diagnostic Test: Serum Chemokine Quantification (ELISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential Gene Expression in Primary Tumor Tissue Associated With CNS Metastases
Identification of genes differentially expressed in primary breast tumor tissue between patients who developed CNS metastases and matched controls without CNS metastases, assessed by mRNA expression profiling using NGS.
Measured: Up to 36 months after baseline
Secondary outcomes (1)
Association Between Baseline Serum Chemokine Concentrations and CNS Metastases
Assessment of serum concentrations of CX3CL1, CXCL13, and CXCL8 (IL-8) measured at diagnosis using ELISA and their association with subsequent development of CNS metastases during follow-up.
Measured: Up to 36 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start7 Jul 2025
- Primary completion31 Dec 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to two parallel groups based on clinical outcome during follow-up (CNS metastases vs. no CNS metastases). Both groups undergo biomarker assessment (primary tumor gene expression profiling and ctDNA ddPCR analysis).
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447544
- Sponsor's protocol ID
- OI-AKRA-CNS-2025
- Other IDs
- 0120-315/2025-2711-3
- Acronym
- AKRA CŽS
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors in Primary Tumor and Liquid Biopsy for the Spread of Early Breast Cancer to the Central Nervous System
- ClinicalTrials.gov ID
- NCT07447544
- Acronym / sponsor ID
- AKRA CŽS / OI-AKRA-CNS-2025
- Conditions
- Breast Cancer, Central Nervous System Metastases
- Keywords
- early-stage breast cancer, molecular biomarkers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to two parallel groups based on clinical outcome during follow-up (CNS metastases vs. no CNS metastases). Both groups undergo biomarker assessment (primary tumor gene expression profiling and ctDNA ddPCR analysis).
| Arm | Type | Receives |
|---|---|---|
| CNS Metastases Group | Experimental | Diagnostic Test: Primary Tumor mRNA Expression Profiling (NGS), Diagnostic Test: Serum Chemokine Quantification (ELISA)Female patients with early-stage breast cancer who developed central nervous system (CNS) metastases during follow-up. Participants undergo molecular biomarker assessment consisting of primary tumor mRNA gene expression profiling using next-generation sequencing (NGS) and measurement of baseline serum chemokine concentrations (CX3CL1, CXCL13, CXCL8 [IL-8]) using ELISA. |
| Control Group (No CNS Metastases) | Active comparator | Diagnostic Test: Primary Tumor mRNA Expression Profiling (NGS), Diagnostic Test: Serum Chemokine Quantification (ELISA)Matched female patients with early-stage breast cancer who did not develop CNS metastases during follow-up. Participants undergo molecular biomarker assessment consisting of primary tumor mRNA gene expression profiling using next-generation sequencing (NGS) and measurement of baseline serum chemokine concentrations (CX3CL1, CXCL13, CXCL8 [IL-8]) using ELISA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged 18 years or older.
- Diagnosis of early-stage breast cancer.
- Availability of archived primary tumor tissue suitable for mRNA analysis.
- Availability of serum sample suitable for chemokine analysis.
- Patients included in the AKRA cohort with documented follow-up data.
Key exclusion criteria (4 listed)
- Male breast cancer patients.
- Lack of sufficient primary tumor tissue for mRNA analysis.
- Lack of available serum sample for chemokine analysis.
- Incomplete clinical follow-up data preventing classification of CNS metastasis status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | CNS Metastases Group, Control Group (No CNS Metastases) |
| 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. | Diagnostic test | CNS Metastases Group, Control Group (No CNS Metastases) |
Primary outcome
Differential Gene Expression in Primary Tumor Tissue Associated With CNS Metastases
Time frame: Up to 36 months after baseline
Identification of genes differentially expressed in primary breast tumor tissue between patients who developed CNS metastases and matched controls without CNS metastases, assessed by mRNA expression profiling using NGS.
1 secondary outcome
Association Between Baseline Serum Chemokine Concentrations and CNS Metastases
Time frame: Up to 36 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Tumor mRNA Expression Profiling (NGS) and Serum Chemokine Quantification (ELISA) in people with Breast Cancer and Central Nervous System Metastases, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential Gene Expression in Primary Tumor Tissue Associated With CNS Metastases (time frame: Up to 36 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.