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: Randomizedphase 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	Treatment or Intervention	Phase
stage I breast cancer stage II breast cancer	Procedure: conventional surgery  Procedure: surgery	Phase III

Further Study Details: 

OBJECTIVES:

• Compare the long term control of regional disease by sentinel node resection vs sentinel node resection followed by conventional axillary dissection in women with breast cancer who are clinically node negative and pathologically sentinel node negative.
• Compare the effect of these two regimens on the overall and disease-free survival of these patients.
• Compare the morbidity associated with these two regimens in these patients.
• Compare the prognostic value of these two regimens in patients who are sentinel node negative or positive by pathology.
• Determine whether a more detailed pathology investigation can identify a group of patients with a potentially increased risk of systemic recurrence who are node negative by pathology.
• Determine the technical success rate of sentinel node dissection and the variability of technical success rate in a broad population of surgeons.
• Determine the sensitivity of the sentinel node to determine the presence of nodal metastases in these patients. Objectives of quality of life questionnaire in sentinel node-negative patients:
• Compare the severity of self-assessed symptoms and activity limitations of patients treated with these two regimens.
• Compare the severity of self-assessed symptoms and activity limitations after breast cancer surgery in patients whose surgery was on the dominant side vs patients whose surgery was on the non-dominant side.
• Compare the impact of arm edema, range of motion, and sensory neuropathy on self-assessed measures of daily functioning, symptoms, and overall quality of life of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to the surgical treatment plan (lumpectomy vs mastectomy), age (49 and under vs 50 and over), and clinical tumor size (no greater than 2.0 cm vs 2.1-4.0 cm vs at least 4.1 cm). Patients are randomized to one of two surgery arms.

All patients receive technetium (Tc 99m) sulfur colloid injected into normal breast tissue within 1 cm of the primary tumor or biopsy cavity and an intradermal injection of technetium (Tc 99m) sulfur colloid, approximately 0.5-8 hours before surgery. Patients also receive an injection of isosulfan blue dye around the tumor or biopsy cavity after a hot spot is identified with a gamma detector. If a hot spot is not identified, the blue dye is injected after a saline bolus injection.

• Arm I: Patients undergo sentinel node resection immediately followed by conventional axillary dissection.
• Arm II: Patients undergo sentinel node resection and an intraoperative examination of sentinel nodes. Patients with positive sentinel nodes undergo axillary dissection after sentinel node resection.

Patients with cytologically negative sentinel nodes do not undergo axillary dissection.

Patients with cytologically negative but histologically positive sentinel nodes return to surgery for axillary dissection.

Patients with histologically positive sentinel nodes and those in whom the sentinel node is not identified undergo axillary dissection after sentinel node resection.

Patients with pathologically positive, nonaxillary sentinel nodes undergo axillary dissection after sentinel node resection.

Patients with evidence of tumor remaining after surgery undergo a total mastectomy.

Quality of life is assessed at baseline, at weeks 1-3, and then every 6 months for 3 years or until recurrence.

Patients are followed at 1 and 3 weeks, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 5,400 patients will be accrued for this study within 4 years.

Genders Eligible for Study:  Both

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:

• Not specified

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

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

Study chairs or principal investigators

David N. Krag, MD, FACS,  Study Chair,  Vermont Cancer Center at University of Vermont   

Study ID Numbers:  CDR0000066987; NSABP-B-32
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003830
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08