Clinical trial · Interventional
Studying the Role of Circulating Tumor Cell Clusters in Patients With High-risk Early Breast Cancer, Study GALIA
NCT07418125CI-TRIAL-00103585GALIArecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
CTCs, CTC clusters, and ctDNA may predict treatment response and survival in high-risk breast cancer, including IBC.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liquid biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- High risk breast cancer patients
- description
- Adult women with inflammatory breast cancer (stage IIID) and non-inflammatory triple negative and HER2+ subtype (stage IIB to IIIA-C) with adequate health status for neoadjuvant systemic treatment
- interventionNames
- Diagnostic Test: Liquid biopsy
Primary outcomes (4)
- measure
- pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
- timeFrame
- before surgery
- description
- Pathological Complete Response (pCR) in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
- measure
- pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.