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Sentinel Node Biopsy in Breast Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Swedish Cancer Society
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT01351974
First received: May 10, 2011
Last updated: May 27, 2011
Last verified: June 2000
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Axillary recurrence after negative sentinel node biopsy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients with primary breast cancer in Swedish hospitals

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351974

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

Publications:

Responsible Party: Leif Bergkvist, Centre for Clinical Research, Uppsala University
ClinicalTrials.gov Identifier: NCT01351974     History of Changes
Other Study ID Numbers: 00-053
Study First Received: May 10, 2011
Last Updated: May 27, 2011
Health Authority: Sweden: The National Board of Health and Welfare

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

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013