Clinical trial · Observational
TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes
Prospective, Multicentric Registry Study Evaluating the False-negative Rate of Targeted Axillary Dissection (TAD) in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes Under Neoadjuvant Systemic Therapy (SenTa 2)
- 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)
Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0/Tis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated. The present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Node-positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- False-negative rate (FNR) of TAD in patients with ycN0 status
- timeFrame
- Postoperatively immediately after histopathological evaluation of LNs
- description
- The FNR of TAD is calculated as the number of patients with histologically negative TAD lymph nodes (LNs) who were found to have positive LNs in the ALND specimen, divided by the total number of patients with positive LNs.
Secondary outcomes (12)
- measure
- Detection rate of preoperative ultrasound
- timeFrame
- Preoperatively
- description
- Preoperative detection rate (DR) of initially marked target lymph nodes (TLNs) on ultrasound images after the end of NST
- measure
- Localization of TLNs
- timeFrame
- Preoperatively or during NST
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * signed informed consent form * female/male patient aged ≥ 18 years * clinical (c) tumor stage T1-4c, bilateral breast cancer and multifocal tumor allowed * invasive breast cancer confirmed by core biopsy * clinically node positive (cN+) (by means of axillary ultrasound or other imaging methods) with ≥ 3 clinically suspicious lymph nodes * biopsy-proven axillary lymph node involvement * marking (e.g. with a clip, magnetic seed, carbon suspension) of the clinically suspicious lymph node(s) before the start of NST * without distant metastases * indication for NST including chemotherapy * TAD + ALND planned * at least 7 lymph nodes (TAD + ALND) planned for histological analysis Exclusion Criteria: * cN0 or cN+ with ≤ 2 clinically suspicious lymph nodes * patients without indication for NST or NST \< 12 weeks * NST without chemotherapy * adjuvant/ neoadjuvant therapy already started prior to inclusion in the study * patients for whom only ALND is planned * ycN+ (by means of axillary ultrasound or other imaging methods) * recurrent breast cancer * larger surgery of the breast (starting from quadrant resection) or the axilla prior to the study * previous radiotherapy of the breast or axilla * inflammatory breast cancer * extramammary breast cancer * pregnant women * not able to undergo surgery * inability to understand the purpose of the clinical study or to comply with study conditions
References
Publications (1)
- BACKGROUNDKuemmel 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