Clinical trial · Observational
Validation of TAD in HER-2 with More Than 2 Lymph Nodes
It is Possible to Reduce the Performance of Axillary Lymphadenectomies in Patients with HER2-positive Breast Cancer with a Clinically Positive Axilla At Diagnosis
NCT06821490CI-TRIAL-00085852DAD-HER2enrolling by invitationClinicalTrials.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 main objective of the study is to validate the DAT technique in patients with Her2-positive breast cancer who have more than two positive axillary lymph nodes at diagnosis. After receiving adequate oncological treatment and axillary assessment by ultrasound for complete radiological response, DAT and Berg level I and II lymphadenectomy will be performed to assess false negatives and positives, as well as their sensitivity and specificity.
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 Carcinoma Metastatic in Lymph Node | — | UNRESOLVED | — |
| HER2 Positive Breast Carcinoma | HER2-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targeted axillary dissection and subsequently a lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- her2positive
- description
- Patients who, at diagnosis, have more than 2 affected axillary lymph nodes. Patients in whom the most caudal affected lymph node is marked. After neoadjuvant treatment, a good axillary response is evidenced by ultrasound
- interventionNames
- Procedure: Targeted axillary dissection and subsequently a lymphadenectomy
Primary outcomes (1)
- measure
- Location of the marked lymph node and the sentinel lymph node, and assessment after lymphadenectomy of number of true positives and negatives, sensitivity and specificity
- timeFrame
- From enrollment to the end of treatment at 12 months
- description
- Determining the number of positive and negative nodes in targeted axillary dissection and axillary lymphadenectomy
Secondary outcomes (2)
- measure
- Detection of the axillary lymph node marked at diagnosis and Detection of the sentinel lymph node and concordance between marked lymph node and sentinel lymph node
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG 0-1 (physical condition: able to walk and live a normal life) * Patients with early-stage breast cancer (BC) with histopathological diagnosis of HER2+ and axillary involvement. Patients with either positive or negative hormonal receptor expression will be included. * Patients must have marked the pathological axillary lymph node. * Any number of affected or suspicious lymph nodes at diagnosis is allowed. * Patients will receive appropriate neoadjuvant treatment based on a combination of chemotherapy and anti-HER2 therapy. • After neoadjuvant treatment and prior to surgery, radiological response will be assessed. * No relevant comorbidities, adequate liver and kidney function, and no contraindications to receive neoadjuvant treatment followed by surgery and radiotherapy. Exclusion Criteria: * Patients with inoperable breast cancer. * Patients with a diagnosis of inflammatory breast cancer. * Patients without a diagnostic biopsy of the suspicious lymph node or the presence of axillary conglomerate.
References
Publications (9)
- BACKGROUNDNg S, Sabel MS, Hughes TM, Chang AE, Dossett LA, Jeruss JS. Impact of Breast Cancer Pretreatment Nodal Burden and Disease Subtype on Axillary Surgical Management. J Surg Res. 2021 May;261:67-73. doi: 10.1016/j.jss.2020.12.007. Epub 2021 Jan 6. PMID 33421795
- BACKGROUNDGasparri ML, de Boniface J, Poortmans P, Gentilini OD, Kaidar-Person O, Banys-Paluchowski M, Di Micco R, Niinikoski L, Murawa D, Bonci EA, Pasca A, Rubio IT, Karadeniz Cakmak G, Kontos M, Kuhn T. Axillary surgery after neoadjuvant therapy in initially node-positive breast cancer: international EUBREAST survey. Br J Surg. 2022 Aug 16;109(9):857-863. doi: 10.1093/bjs/znac217. PMID 35766257
- BACKGROUNDSimons JM, Jacobs JG, Roijers JP, Beek MA, Boonman-de Winter LJM, Rijken AM, Gobardhan PD, Wijsman JH, Tetteroo E, Heijns JB, Yick CY, Luiten EJT. Disease-free and overall survival after neoadjuvant chemotherapy in breast cancer: breast-conserving surgery compared to mastectomy in a large single-centre cohort study. Breast Cancer Res Treat. 2021 Jan;185(2):441-451. doi: 10.1007/s10549-020-05966-y. Epub 2020 Oct 19. PMID 33073303
- BACKGROUNDGalimberti V, Ribeiro Fontana SK, Vicini E, Morigi C, Sargenti M, Corso G, Magnoni F, Intra M, Veronesi P. "This house believes that: Sentinel node biopsy alone is better than TAD after NACT for cN+ patients". Breast. 2023 Feb;67:21-25. doi: 10.1016/j.breast.2022.12.010. Epub 2022 Dec 20. PMID 36566690
- BACKGROUNDCha C, Ahn SG, Kim D, Lee J, Park S, Bae SJ, Kim JY, Park HS, Park S, Kim SI, Park BW, Jeong J. Axillary response according to neoadjuvant single or dual human epidermal growth factor receptor 2 (HER2) blockade in clinically node-positive, HER2-positive breast cancer. Int J Cancer. 2021 Oct 15;149(8):1585-1592. doi: 10.1002/ijc.33726. Epub 2021 Jul 8. PMID 34213778
- BACKGROUNDBernet L, Piñero A, Martínez M, Sicart SV, Algara M, Palomares E. Consensus of the Spanish Society of Breast Senology and Pathology (SESPM) on Selective Biopsy of the Sentinel Node (BSGC) and axylar management in breast cancer (2022). Revista de Senologia y Patologia Mamaria. 2022 Oct 1;35(4):243-59.