Sentinel Node Biopsy in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01351974
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : May 30, 2011
Swedish Cancer Society
Information provided by:
Uppsala University

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.

Condition or disease
Recurrence Breast Cancer

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 3369 participants
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
Study Start Date : September 2000
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. 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

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: Leif Bergkvist, Centre for Clinical Research, Uppsala University Identifier: NCT01351974     History of Changes
Other Study ID Numbers: 00-053
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: June 2000

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