Clinical trial · Interventional
Sentinel Lymph Node Biopsy in Patients With Breast Cancer After Neoadjuvant Therapy
NCT03556397CI-TRIAL-00050149completedN/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 aim of this study is to create clear indications for Sentinel Lymph Node Biopsy (SLNB) or Axillary Dissection (AD) in women with breast carcinoma after neoadjuvant therapy by studying the false negative rate of SLNB.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary dissection | Procedure | — | UNRESOLVED |
| Sentinel lymph node biopsy (SLNB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- cN0 before and after neoadjuvant th., SLNB - negative, no AD
- description
- Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD
- interventionNames
- Procedure: Sentinel lymph node biopsy (SLNB)
- type
- EXPERIMENTAL
- label
- cN0 before and after neoadjuvant th., SLNB - posit., AD
- description
- Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II)
- interventionNames
- Procedure: Sentinel lymph node biopsy (SLNB)
- Procedure: Axillary dissection
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of breast carcinoma confirmed by biopsy * neoadjuvant therapy * examination of axillary lymph nodes clinically and by ultrasound * surgical therapy after neoadjuvant therapy Exclusion Criteria: * inflammatory breast carcinoma * incomplete neoadjuvant therapy * previous sentinel lymph node biopsy performed on the same side of the body * disagreement with participation in the study * other malignities influencing the treatment of breast carcinoma * distant metastases
References
Publications (2)
- 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
- BACKGROUNDCaudle AS, Hunt KK, Tucker SL, Hoffman K, Gainer SM, Lucci A, Kuerer HM, Meric-Bernstam F, Shah R, Babiera GV, Sahin AA, Mittendorf EA. American College of Surgeons Oncology Group (ACOSOG) Z0011: impact on surgeon practice patterns. Ann Surg Oncol. 2012 Oct;19(10):3144-51. doi: 10.1245/s10434-012-2531-z. Epub 2012 Jul 31. PMID 22847123