Clinical trial · Observational
Registry Trial to Evaluate the Clinical Utilization of Targeted Axillary Dissection (TAD)
A Prospective, Multicenter, Registry Trial to Evaluate Utilization Frequency and Feasibility of Targeted Axillary Dissection (TAD) After Needle Biopsy and Clip Placement in Early Breast Cancer With Clinically Affected Lymph Nodes
- 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)
A downstaging of axillary tumor-spread can be achieved in about 40% of the patients receiving neoadjuvant chemotherapy (NACT). The impact of NACT on loco-regional tumor control has not yet been sufficiently investigated. Moreover the pathologic nodal status after NACT is a strong prognostic marker. Therefore it is most desirable to identify the approximately 40% of patients with pathologic complete response of the axilla, that could be spared from a potentially non beneficial axillary lymph node dissection (ALND). Attempts to identify these patients via sentinel lymph node biopsy (SLNB) after NACT have failed to provide acceptable false negative rates (FNR). The new concept of targeted axillary dissection (TAD) following NACT has shown promising results. Still multiple information about the clinical adoption of this procedure into clinical practice are missing. The SenTa registry trial is designed to assess the clinical implementation of TAD into general practice.
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 |
|---|---|---|---|
| Early Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Not suitable for TAD | Other | — | UNRESOLVED |
| Suitable for TAD | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- CNB biopsy/clip placement not done
- description
- Clinically affected lymph nodes cannot be biopsied or clip labeled. Patients are not suitable for TAD
- interventionNames
- Other: Not suitable for TAD
- label
- CNB/clip placement done - benign
- description
- Clinically affected lymph nodes can be biopsied and clip labeled. Needle biopsy reveals no axillary tumor spread. Patients are suitable for TAD
- interventionNames
- Procedure: Suitable for TAD
- label
- CNB/clip placement done - malignant
- description
- Clinically affected lymph nodes can be biopsied and clip labeled. Needle biopsy reveals axillary tumor spread. Patients are suitable for TAD
- interventionNames
- Procedure: Suitable for TAD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * informed consent * invasive mamma carcinoma verified by needle biopsy of the primary tumor * nodal positive (cN+) verified by axillary ultrasound * cT stage 1-4c, multifocality allowed * no sign of distant metastasis (cM0) Exclusion Criteria: * prior history of breast cancer * prior ipsilateral extensive surgery of breast or axilla * inflammatory or extramammary breast cancer * pregnancy * inability to understand the studies purpose * no written patient informed consent
References
Publications (4)
- BACKGROUNDCaudle AS, Yang WT, Krishnamurthy S, Mittendorf EA, Black DM, Gilcrease MZ, Bedrosian I, Hobbs BP, DeSnyder SM, Hwang RF, Adrada BE, Shaitelman SF, Chavez-MacGregor M, Smith BD, Candelaria RP, Babiera GV, Dogan BE, Santiago L, Hunt KK, Kuerer HM. Improved Axillary Evaluation Following Neoadjuvant Therapy for Patients With Node-Positive Breast Cancer Using Selective Evaluation of Clipped Nodes: Implementation of Targeted Axillary Dissection. J Clin Oncol. 2016 Apr 1;34(10):1072-8. doi: 10.1200/JCO.2015.64.0094. Epub 2016 Jan 25. PMID 26811528
- BACKGROUNDBoughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932. PMID 24101169
- BACKGROUNDKuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15. PMID 23683750
- RESULTKuemmel S, Heil J, Rueland A, Seiberling C, Harrach H, Schindowski D, Lubitz J, Hellerhoff K, Ankel C, Grasshoff ST, Deuschle P, Hanf V, Belke K, Dall P, Dorn J, Kaltenecker G, Kuehn T, Beckmann U, Potenberg J, Blohmer JU, Kostara A, Breit E, Holtschmidt J, Traut E, Reinisch M. A Prospective, Multicenter Registry Study to Evaluate the Clinical Feasibility of Targeted Axillary Dissection (TAD) in Node-positive Breast Cancer Patients. Ann Surg. 2022 Nov 1;276(5):e553-e562. doi: 10.1097/SLA.0000000000004572. Epub 2020 Nov 4. PMID 33156057