Clinical trial · Interventional
Prospective Evaluation of Targeted Axillary Dissection (TAD)
TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients With Breast Cancer With Advanced Nodal Disease at Diagnosis
NCT04998682CI-TRIAL-00106470TADcompletedN/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 research is to evaluate how to manage the axillary lymph nodes in patients with breast cancer. The investigators will determine if a sampling of the lymph nodes under the arm will give the information necessary to determine if fewer lymph nodes can be removed.
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 |
|---|---|---|---|
| Axillary Dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Targeted Axillary Dissection (TAD)
- description
- During standard of care (SoC) surgery to remove breast cancer, study participants will undergo a sampling of lymph nodes in the axilla first and then complete removal of axillary lymph nodes under the arm.
- interventionNames
- Procedure: Axillary Dissection
Primary outcomes (1)
- measure
- False Negative Rate
- timeFrame
- Up to 2 weeks
- description
- The false negative rate of targeted axillary dissection after neoadjuvant systemic therapy (NST) in study participants. A false negative event will be defined as a case where the specific node (either the clipped node or the sentinel lymph node, depending on the analysis) does not show metastasis even though residual disease is identified in the other axillary nodes. The false negative rate will be computed as the number of false negative events divided by the total number of pathologically node-positive patients.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women or men greater than or equal to 18 years. * Histologically confirmed invasive adenocarcinoma of the breast. * Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition) * Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam. * Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease. * Patients must have biopsy proven involvement of the axillary lymph nodes. * Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype. * Candidate for surgical management of breast cancer. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye. * Pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.