Clinical trial · Interventional
To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes
To Accurately Assess Lymph Node Response to Neoadjuvant Chemotherapy by Wire Localization of Clip-marked Axillary Lymph Nodes in Breast Cancer Patients
- 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 investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage N1 (cN1) breast cancer patients. Accuracy of sentinel lymph node biopsy (SLNB) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. New model to predict lymph node pathological complete remission (pCR) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients is sought for.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastases | — | UNRESOLVED | — |
| Neoadjuvant Chemotherapy | — | UNRESOLVED | — |
| Neoplasm, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Response | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| wire localization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Wire localization
- description
- Intervention: procedure: wire localization
- interventionNames
- Procedure: wire localization
Primary outcomes (1)
- measure
- The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes.
- timeFrame
- through study completion, an average of 1 year
- description
- Sensitivity, specificity, false negative rate and negative predictive value will be calculated.
Secondary outcomes (1)
- measure
- Model to predict lymph node pCR in cN1 patients.
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * between the age of 18 and 65 * Eastern Cooperative Oncology Group (ECOG) score 0 or 1 * pathologically proven positive axillary lymph node * enough renal and liver function to sustain chemotherapy * informed consent obtained Exclusion Criteria: * inflammatory breast cancer * being pregnant or nursing * neoadjuvant chemotherapy not planned
References
Publications (1)
- DERIVEDWang X, Zheng Q, He Y, Liu Y, Huo L, Zhang N, Wang T, Xie Y, Li J, Ouyang T, Fan Z. Diagnostic accuracy of sentinel lymph node biopsy and wire localized clipped node biopsy after neoadjuvant chemotherapy in node-positive breast cancer. Surg Today. 2025 Feb;55(2):172-179. doi: 10.1007/s00595-024-02981-0. Epub 2024 Dec 27. PMID 39725764