Clinical trial · Interventional
Axillary Lymph Node Changes After Neoadjuvant Therapy In Breast Cancer
Implications Of Posttreatment Changes In Axillary Lymph Nodes And Axillary Surgical Procedure Optimization In Breast Cancer Patients After Neoadjuvant Systemic Treatment
NCT07428720CI-TRIAL-00103916active not recruitingN/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 purpose of this study is to improve regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) who received neoadjuvant systemic treatment (NAST) by using ultrasound elastography.
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 |
|---|---|---|---|
| Axillary Lymph Node Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound Elastography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ultrasound Elastography Assessment
- description
- Breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment undergo ultrasound elastography assessment to identify metastases or regressive changes in axillary lymph nodes.
- interventionNames
- Device: Ultrasound Elastography
Primary outcomes (1)
- measure
- Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Residual Axillary Lymph Node Metastasis After NAST
- timeFrame
- Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).
- description
- Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of residual metastatic disease after neoadjuvant systemic treatment (NAST), using histopathological examination of excised lymph nodes as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), positive predictive value (PPV, %), and negative predictive value (NPV, %).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18 years or older * Histologically confirmed breast cancer * Clinically positive axillary lymph nodes before neoadjuvant systemic treatment (cN+) * Completed neoadjuvant systemic treatment (NAST) * Planned axillary surgery (sentinel lymph node biopsy and/or axillary lymph node dissection) * Ability to provide written informed consent Exclusion Criteria: * Age \< 18 years * Male patients * Metastatic disease at diagnosis * Inflammatory breast cancer * New primary breast cancer * Bilateral breast cancer * Pregnancy * Previous breast or axillary surgery
References
Publications (0)
Data not yet available
No reference posted for this study.