Clinical trial · Observational
Sentinel Node Biopsy in Breast Cancer Patients
Cohort Study of Axillary Recurrences and Survival After Negative Negative Sentinel Node Biopsy Without Completion Axillary Clearance
- 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)
Axillary lymph node dissection (ALND) was previously the standard axillary staging procedure in breast cancer patients. However, ALND is accompanied by a considerable morbidity, and sentinel lymph node biopsy (SLNB) evolved as a mean to decrease this morbidity. Between September 2000 and January 2004 breast cancer patients were included in the Swedish Sentinel Node Multicenter Cohort Study with the intent of studying axillary recurrence after negative SLNB for patients in which completion ALND were omitted. The patients were followed prospectively and events (local, regional and distant recurrences and deaths) were registered. The primary endpoint was axillary recurrence and secondary endpoints were disease-free, cancer-specific and overall survival.
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 |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Axillary recurrence after negative sentinel node biopsy
- timeFrame
- 5 years
- description
- Prospective follow-up of axillary recurrences in patients with negative sentinel lymph node biopsy in which completion axillary lymph node dissection were omitted
Secondary outcomes (1)
- measure
- Survival
- timeFrame
- 5 years
- description
- Survival (disease-free, cancer-specific and overall) in the sentinel lymph node biopsy cohort
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Primary invasive breast cancer Exclusion Criteria: * Preoperatively diagnosed axillary metastases * Multifocal tumors * Tumors \> 3 cm * Impalpable tumors * Earlier resection of the tumor * Neoadjuvant treatment * Pregnancy
References
Publications (2)
- RESULTAndersson Y, Frisell J, Sylvan M, de Boniface J, Bergkvist L. Breast cancer survival in relation to the metastatic tumor burden in axillary lymph nodes. J Clin Oncol. 2010 Jun 10;28(17):2868-73. doi: 10.1200/JCO.2009.24.5001. Epub 2010 May 10. PMID 20458033
- RESULTBergkvist L, de Boniface J, Jonsson PE, Ingvar C, Liljegren G, Frisell J; Swedish Society of Breast Surgeons. Axillary recurrence rate after negative sentinel node biopsy in breast cancer: three-year follow-up of the Swedish Multicenter Cohort Study. Ann Surg. 2008 Jan;247(1):150-6. doi: 10.1097/SLA.0b013e318153ff40. PMID 18156935