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Sentinel Node Biopsy in Breast Cancer Patients

This study has been completed.
Swedish Cancer Society
Information provided by:
Uppsala University Identifier:
First received: May 10, 2011
Last updated: May 27, 2011
Last verified: June 2000
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.

Recurrence Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study of Axillary Recurrences and Survival After Negative Negative Sentinel Node Biopsy Without Completion Axillary Clearance

Resource links provided by NLM:

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Axillary recurrence after negative sentinel node biopsy [ Time Frame: 5 years ]
    Prospective follow-up of axillary recurrences in patients with negative sentinel lymph node biopsy in which completion axillary lymph node dissection were omitted

Secondary Outcome Measures:
  • Survival [ Time Frame: 5 years ]
    Survival (disease-free, cancer-specific and overall) in the sentinel lymph node biopsy cohort

Biospecimen Retention:   Samples Without DNA
Routine specimens from the surgery are kept at the respective pathology departments

Enrollment: 3369
Study Start Date: September 2000
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with primary breast cancer in Swedish hospitals

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01351974

Centre for Clinical Research, Uppsala University
Västerås, Sweden, 72189
Sponsors and Collaborators
Uppsala University
Swedish Cancer Society
Principal Investigator: Leif Bergkvist, M.D. Ph.D. Centre for Clinical Research, Uppsala University
  More Information

Responsible Party: Leif Bergkvist, Centre for Clinical Research, Uppsala University Identifier: NCT01351974     History of Changes
Other Study ID Numbers: 00-053
Study First Received: May 10, 2011
Last Updated: May 27, 2011

Keywords provided by Uppsala University:
breast cancer
sentinel lymph node biopsy
axillary recurrence

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes processed this record on September 21, 2017