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| Sponsor: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003830 |
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 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients |
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Resectable invasive adenocarcinoma of the breast, confirmed by 1 of the following:
Clinically negative lymph nodes
No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No prior malignancy within past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study 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 | |
| Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | |
| San Diego, California, United States, 92120 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305-5408 | |
| Sutter Breast Cancer Group | |
| Sacramento, California, United States, 95819-5156 | |
| 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 | |
| Baptist Regional Cancer Institute - Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| Halifax Medical Center | |
| Daytona Beach, Florida, United States, 32114 | |
| Sarasota Memorial Hospital | |
| Sarasota, Florida, United States, 34239 | |
| University of Miami Sylvester Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| Creticos Cancer Center at Advocate Illinois Masonic Medical Center | |
| Chicago, Illinois, United States, 60657 | |
| MBCCOP-Cook County Hospital | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Methodist Cancer Center at Methodist Hospital | |
| Indianapolis, Indiana, United States, 46206-1367 | |
| 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 - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| 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 | |
| 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 | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267-0502 | |
| Aultman Hospital Cancer Center at Aultman Health Foundation | |
| Canton, Ohio, United States, 44710 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Kettering, Ohio, United States, 45429 | |
| Akron City Hospital | |
| Akron, Ohio, United States, 44312 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Jewish Hospital of Cincinnati, Incorporated | |
| Cincinnati, Ohio, United States, 45236 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212-4772 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| 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 | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| United States, Vermont | |
| Vermont Cancer Center at University of Vermont | |
| Burlington, Vermont, United States, 05401-3498 | |
| United States, Virginia | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Virginia Oncology Associates - Newport News | |
| Newport News, Virginia, United States, 23606 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| Puget Sound Oncology Consortium | |
| Seattle, Washington, United States, 98109 | |
| 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 | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L-4M1 | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| 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 | |
| Puerto Rico | |
| MBCCOP - San Juan | |
| San Juan, Puerto Rico, 00927-5800 | |
| Study Chair: | David N. Krag, MD, FACS | University of Vermont |
More Information
| Study ID Numbers: | CDR0000066987, NSABP-B-32 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003830 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |