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Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
NSABP Foundation Inc
ClinicalTrials.gov Identifier:
NCT00003830
First received: November 1, 1999
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer. It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer.


Condition Intervention Phase
Breast Cancer
Procedure: conventional surgery
Procedure: Sentinel node resection followed by node examination
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by NSABP Foundation Inc:

Primary Outcome Measures:
  • Morbidity as measured by arm edema, sensory neuropathy, and arm function - mobility [ Time Frame: Before and after surgery ] [ Designated as safety issue: No ]
  • Overall Survival as measured by death from any cause. [ Time Frame: Time from surgery to death from any cause ] [ Designated as safety issue: No ]
  • Disease-free Survival as measured by breast cancer recurrence, any second primary cancer, and death from any cause in patients without a prior event. [ Time Frame: Time from surgery to recurrence, second primary, or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prognostic value of pathology status of sentinel nodes and nodes obtained from axillary dissection [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
  • Pathology investigation of sentinel nodes [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • The percentage of technically successful sentinel node resections as measured by the proportion of patients for whom at least one sentinel node is identified. [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Sensitivity of the sentinel node to determine presence of nodal metastases. [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

Enrollment: 5611
Study Start Date: May 1999
Study Completion Date: February 2014
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I: Conventional axillary dissection
Sentinel node resection immediately followed by axillary dissection
Procedure: conventional surgery
Sentinel node resection immediately followed by axillary dissection.
Experimental: Arm II: Sentinel node resection followed by node examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
Procedure: Sentinel node resection followed by node examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Resectable invasive adenocarcinoma of the breast, confirmed by 1 of the following:

    • Histologically confirmed by core or open biopsy
    • Confirmed by fine needle aspiration cytology AND positive clinical breast examination and ultrasound or mammography
  • Clinically negative lymph nodes

    • No positive ipsilateral axillary lymph nodes
    • No prior removal of ipsilateral axillary lymph nodes
    • No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy
  • No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude

    • Tethering or dimpling of the skin or nipple inversion allowed
  • No bilateral malignancy or mass in the opposite breast that is suspicious for malignancy, unless proven nonmalignant by biopsy
  • No diffuse tumors or multiple malignant tumors in different quadrants of the breast
  • No other prior breast malignancy except lobular carcinoma in situ
  • No prior or concurrent breast implants
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 years and older

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • At least 10 years (excluding diagnosis of cancer)

Hematopoietic:

  • Not specified

Hepatic:

  • No hepatic systemic disease

Renal:

  • No renal systemic disease

Cardiovascular:

  • No cardiovascular systemic disease

Other:

  • No prior malignancy within past 5 years except:

    • Effectively treated squamous cell or basal cell skin cancer
    • Surgically treated carcinoma in situ of the cervix
    • Surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast
  • No concurrent psychiatric or addictive disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for this cancer

Chemotherapy:

  • No prior chemotherapy for this cancer, including neoadjuvant chemotherapy

Endocrine therapy:

  • No prior hormonal therapy for this cancer

Radiotherapy:

  • No prior radiotherapy for this cancer

Surgery:

  • See Disease Characteristics
  • No prior breast reduction surgery
  • Prior excisional biopsy or lumpectomy allowed
  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 ClinicalTrials.gov identifier: NCT00003830

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sutter Breast Cancer Group
Sacramento, California, United States, 95819-5156
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States, 92120
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, District of Columbia
MBCCOP - Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Florida
Halifax Medical Center
Daytona Beach, Florida, United States, 32114
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
University of Miami Sylvester Cancer Center
Miami, Florida, United States, 33136
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
MBCCOP-Cook County Hospital
Chicago, Illinois, United States, 60612
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
United States, Indiana
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46206-1367
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Louisiana
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Michigan State University
East Lansing, Michigan, United States, 48824
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
Providence Cancer Institute at Providence Hospital
Southfield, Michigan, United States, 48075-9975
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
New York Oncology Hematology, P.C. - Albany Regional Cancer Center
Albany, New York, United States, 12208
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44312
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0502
Jewish Hospital of Cincinnati, Incorporated
Cincinnati, Ohio, United States, 45236
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Kettering, Ohio, United States, 45429
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
United States, Utah
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Virginia Oncology Associates - Newport News
Newport News, Virginia, United States, 23606
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
Puget Sound Oncology Consortium
Seattle, Washington, United States, 98109
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
United States, West Virginia
Camcare Health
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Jewish General Hospital - Montreal
Montreal, Quebec, Canada, H3T 1E2
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada, H3A 1A1
St. Mary's Hospital Center
Montreal, Quebec, Canada, H3T 1M5
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Puerto Rico
MBCCOP - San Juan
San Juan, Puerto Rico, 00927-5800
Sponsors and Collaborators
NSABP Foundation Inc
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc
  More Information

Additional Information:
Publications:
Land SR, Kopec JA, Lee M, et al.: Quality of life in breast cancer patients receiving sentinel-node (SN) biopsy alone or with axillary dissection (AD): results from NSABP protocol B-32. [Abstract] J Clin Oncol 26 (Suppl 15): A-9533, 2008.
Julian TB, Anderson SJ, Fourchotte V, et al.: Is completion axillary dissection always required after a positive sentinel node biopsy? NSABP B-32. [Abstract] Breast Cancer Res Treat 106 (1): A-51, S15, 2007.
Julian TB, Anderson SJ, Fourchotte V, et al.: Is intraoperative cytology of sentinel nodes useful and predictive for non-sentinel axillary nodes? NSABP B-32. [Abstract] Breast Cancer Res Treat 106 (1): A-3001, 2007.
Julian B, Fourchotte V, Anderson S, et al.: Predictive factors that identify patients not requiring a sentinel node biopsy: continued analysis of the NSABP B-32 sentinel node trial. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-2003, S80-1, 2006.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00003830     History of Changes
Other Study ID Numbers: NSABP B-32, U10CA012027, CDR0000066987
Study First Received: November 1, 1999
Last Updated: March 6, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by NSABP Foundation Inc:
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014