Clinical trial · Interventional
CTCs in Breast Cancer After Neoadjuvant Treatment and Surgery: a Multicenter, Prospective Clinical Trial
The Value of Circulating Tumor Cells in Patients With Breast Cancer Who Completed Surgery After Neoadjuvant Treatment: a Multicenter, Prospective Clinical Trial
NCT05360290CI-TRIAL-00102259CTCNeoBC-ErecruitingN/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)
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. This is a prospective, multicenter study to evaluate the prognostic value of circulating tumor cells in breast cancer patients who completed surgery after neoadjuvant treatment.
Conditions
Conditions (2)
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 |
| Circulating Tumor Cell | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GILUPI CellCollector® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CTC positive
- interventionNames
- Device: GILUPI CellCollector®
- type
- OTHER
- label
- CTC negative
- interventionNames
- Device: GILUPI CellCollector®
Primary outcomes (1)
- measure
- invasive disease-free survival (iDFS)
- timeFrame
- From surgery until time of event up to 3 years
- description
- Invasive disease-free survival time is defined as the time from date of randomization until the first occurrence of invasive disease recurrence, distant metastasis and death from any cause.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female, aged ≥18 and ≤70 years; * Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 before neoadjuvant treatment); * Completed neoadjuvant treamtment and surgery (within 4 years after surgery); * Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen); * ECOG 0-1 Exclusion Criteria: * Metastatic disease (Stage IV); * Female patients who are pregnancy or lactation; * Uncontrollable puncture site infection or systemic infection;
References
Publications (0)
Data not yet available
No reference posted for this study.