Clinical trial · Interventional
CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial
Predictive Value of Circulating Tumor Cells in Neoadjuvant Chemotherapy Among Locally Advanced Breast Cancer Patients: a Single-center, Prospective, Exploratory Clinical Trial
NCT03732339CI-TRIAL-00058170CTCNeoBCcompletedN/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. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.
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 |
|---|---|---|---|
| Circulating Tumor Cell | — | UNRESOLVED | — |
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GILUPI CellCollector® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GILUPI CellCollector®
- interventionNames
- Device: GILUPI CellCollector®
Primary outcomes (1)
- measure
- Predictive value of CTC in ypT0 ypN0
- timeFrame
- Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy
Secondary outcomes (3)
- measure
- Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR
- timeFrame
- before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
- measure
- hypersensitivity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy * ECOG 0-1 * Adequate organ function * Consent to undergo CTC analysis in vivo Exclusion Criteria: * Pregnant or breastfeeding patients * Metastatic or recurrent patients * Uncontrollable infection
References
Publications (0)
Data not yet available
No reference posted for this study.