Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
NCT ID: NCT00003830
Last Updated: 2017-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
5611 participants
INTERVENTIONAL
1999-05-31
2014-02-28
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I: Conventional axillary dissection
Sentinel node resection immediately followed by axillary dissection
conventional surgery
Sentinel node resection immediately followed by axillary dissection.
Arm II: Sentinel node resection followed by node examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
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.
Interventions
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conventional surgery
Sentinel node resection immediately followed by axillary dissection.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
Responsible Party
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Principal Investigators
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Norman Wolmark, MD
Role: PRINCIPAL_INVESTIGATOR
NSABP Foundation Inc
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Sutter Breast Cancer Group
Sacramento, California, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States
Halifax Medical Center
Daytona Beach, Florida, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States
University of Miami Sylvester Cancer Center
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
MBCCOP-Cook County Hospital
Chicago, Illinois, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Beaumont
Royal Oaks, Michigan, United States
Providence Cancer Institute at Providence Hospital
Southfield, Michigan, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
New York Oncology Hematology, P.C. - Albany Regional Cancer Center
Albany, New York, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Akron City Hospital
Akron, Ohio, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States
Jewish Hospital of Cincinnati, Incorporated
Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Virginia Oncology Associates - Newport News
Newport News, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Puget Sound Oncology Consortium
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Camcare Health
Charleston, West Virginia, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada
Jewish General Hospital - Montreal
Montreal, Quebec, Canada
St. Mary's Hospital Center
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
MBCCOP - San Juan
San Juan, , Puerto Rico
Countries
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References
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Land SR, Ritter MW, Costantino JP, Julian TB, Cronin WM, Haile SR, Wolmark N, Ganz PA. Compliance with patient-reported outcomes in multicenter clinical trials: methodologic and practical approaches. J Clin Oncol. 2007 Nov 10;25(32):5113-20. doi: 10.1200/JCO.2007.12.1749.
Weaver DL, Le UP, Dupuis SL, Weaver KA, Harlow SP, Ashikaga T, Krag DN. Metastasis detection in sentinel lymph nodes: comparison of a limited widely spaced (NSABP protocol B-32) and a comprehensive narrowly spaced paraffin block sectioning strategy. Am J Surg Pathol. 2009 Nov;33(11):1583-9. doi: 10.1097/PAS.0b013e3181b274e7.
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.
Krag DN, Anderson SJ, Julian TB, Brown AM, Harlow SP, Ashikaga T, Weaver DL, Miller BJ, Jalovec LM, Frazier TG, Noyes RD, Robidoux A, Scarth HM, Mammolito DM, McCready DR, Mamounas EP, Costantino JP, Wolmark N; National Surgical Adjuvant Breast and Bowel Project. Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial. Lancet Oncol. 2007 Oct;8(10):881-8. doi: 10.1016/S1470-2045(07)70278-4.
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.
Weaver DL, Krag DN, Manna EA, Ashikaga T, Waters BL, Harlow SP, Bauer KD, Julian TB. Detection of occult sentinel lymph node micrometastases by immunohistochemistry in breast cancer. An NSABP protocol B-32 quality assurance study. Cancer. 2006 Aug 15;107(4):661-7. doi: 10.1002/cncr.22074.
Harlow SP, Krag DN, Julian TB, Ashikaga T, Weaver DL, Feldman SA, Klimberg VS, Kusminsky R, Moffat FL Jr, Noyes RD, Beitsch PD. Prerandomization Surgical Training for the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-32 trial: a randomized phase III clinical trial to compare sentinel node resection to conventional axillary dissection in clinically node-negative breast cancer. Ann Surg. 2005 Jan;241(1):48-54. doi: 10.1097/01.sla.0000149429.39656.94.
Weaver DL, Ashikaga T, Krag DN, Skelly JM, Anderson SJ, Harlow SP, Julian TB, Mamounas EP, Wolmark N. Effect of occult metastases on survival in node-negative breast cancer. N Engl J Med. 2011 Feb 3;364(5):412-21. doi: 10.1056/NEJMoa1008108. Epub 2011 Jan 19.
Krag DN, Anderson SJ, Julian TB, Brown AM, Harlow SP, Costantino JP, Ashikaga T, Weaver DL, Mamounas EP, Jalovec LM, Frazier TG, Noyes RD, Robidoux A, Scarth HM, Wolmark N. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):927-33. doi: 10.1016/S1470-2045(10)70207-2.
Other Identifiers
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CDR0000066987
Identifier Type: -
Identifier Source: secondary_id
NSABP B-32
Identifier Type: -
Identifier Source: org_study_id