Sentinel Node Biopsy in Breast Cancer Patients
Cohort Study of Axillary Recurrences and Survival After Negative Negative Sentinel Node Biopsy Without Completion Axillary Clearance
1 other identifier
observational
3,369
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2000
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedMay 30, 2011
June 1, 2000
3.3 years
May 10, 2011
May 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Axillary recurrence after negative sentinel node biopsy
Prospective follow-up of axillary recurrences in patients with negative sentinel lymph node biopsy in which completion axillary lymph node dissection were omitted
5 years
Secondary Outcomes (1)
Survival
5 years
Eligibility Criteria
Consecutive patients with primary breast cancer in Swedish hospitals
You may qualify if:
- Primary invasive breast cancer
You may not qualify if:
- Preoperatively diagnosed axillary metastases
- Multifocal tumors
- Tumors \> 3 cm
- Impalpable tumors
- Earlier resection of the tumor
- Neoadjuvant treatment
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Swedish Cancer Societycollaborator
Study Sites (1)
Centre for Clinical Research, Uppsala University
Västerås, 72189, Sweden
Related Publications (2)
Andersson 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: 20458033RESULTBergkvist 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: 18156935RESULT
Biospecimen
Routine specimens from the surgery are kept at the respective pathology departments
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leif Bergkvist, M.D. Ph.D.
Centre for Clinical Research, Uppsala University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 11, 2011
Study Start
September 1, 2000
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
May 30, 2011
Record last verified: 2000-06