Circulating tumor cell clusters and ctDNA in high-risk early breast cancer
Official title: Studying the Role of Circulating Tumor Cell Clusters in Patients With High-risk Early Breast Cancer, Study GALIA
Run by Institute of Oncology Ljubljana · NCT07418125 · Data updated 2026-11-12
This project will test whether a blood test measuring circulating tumor cell clusters and circulating tumor DNA (ctDNA) can help predict treatment response and outcomes for people with high‑risk early breast cancer, including inflammatory disease and HER2+ or triple‑negative non‑inflammatory cancers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 130 (estimated) |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ljubljana) |
| Status | Recruiting |
| Started | February 7, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | February 18, 2026 |
| Trial ID | NCT07418125 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with high‑risk early breast cancer who can receive neoadjuvant systemic therapy and understand Slovenian, specifically: inflammatory breast cancer stage IIID or non‑inflammatory HER2+ or triple‑negative disease from stage IIB to IIIC.
✕Probably not a fit
Patients with luminal A or B subtypes, stage I–IIA disease, inflammatory breast cancer stage IV, those who start with primary surgery, cannot tolerate chemotherapy, or cannot communicate in Slovenian are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants will have serial liquid biopsies (blood draws) to measure circulating tumor cells, circulating tumor cell clusters, and circulating tumor DNA before, during, and after neoadjuvant systemic therapy. The study focuses on high‑risk early breast cancers: inflammatory breast cancer (stage IIID) and non‑inflammatory HER2+ or triple‑negative cancers from stage IIB to IIIC. Results from the blood assays will be correlated with clinical response to therapy and longer‑term outcomes such as relapse and survival. The work is conducted at the Institute of Oncology Ljubljana and aims to refine biomarkers that could guide treatment decisions.
Why it matters
Potential benefit: If successful, this approach could identify early which patients are not responding to standard therapy so treatments can be changed sooner or personalized to improve outcomes.
How similar studies have gone: Prior work using ctDNA and single circulating tumor cells has shown promise for predicting relapse and treatment response, but the specific predictive value of circulating tumor cell clusters—especially in inflammatory breast cancer—remains less established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with inflammatory breast cancer, regardless of cancer subtype (stage IIID) * Patients with non-inflammatory breast cancer: triple-negative and HER2+ subtypes, from stage IIB to IIIA-C * Adequate health status for neoadjuvant systemic treatment Exclusion Criteria: * Inflammatory breast cancer stage IV * Luminal A, luminal B subtypes of non-inflammatory breast cancer * Stages I-IIA breast cancer * Inability to understand or communicate in Slovenian * Inability to follow protocol instructions * Inappropriate health status for chemotherapy treatment * Primary treatment with surgery
Where it's running
-
Institute of Oncology Ljubljana
Ljubljana, Slovenia Recruiting
Study contacts
- Study coordinator: Klavdija Korošec
- Email: kkorosec@onko-i.si
- Phone: 00386 1 5879 639
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.