A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients
- 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
- Compare the effect of these two regimens on the overall and disease-free survival of
- 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
- 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
- Arm II: Patients undergo sentinel node resection and an intraoperative examination of
Patients with positive sentinel nodes undergo axillary dissection after sentinel node
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
PROJECTED ACCRUAL: Approximately 5,400 patients will be accrued for this study within 4
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Morbidity as measured by arm edema, sensory neuropathy, and arm function - mobility
Before and after surgery
Norman Wolmark, MD
NSABP Foundation, Inc.
United States: Federal Government
|Akron City Hospital||Akron, Ohio 44304|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Mount Sinai Medical Center||Miami Beach, Florida 33140|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|MBCCOP - Massey Cancer Center||Richmond, Virginia 23298-0037|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|Methodist Cancer Center at Methodist Hospital||Indianapolis, Indiana 46202|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|Geisinger Medical Center||Danville, Pennsylvania 17822-0001|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|Halifax Medical Center||Daytona Beach, Florida 32114|
|CCOP - Montana Cancer Consortium||Billings, Montana 59101|
|Newark Beth Israel Medical Center||Newark, New Jersey 07112|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Dayton||Kettering, Ohio 45429|
|Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|CCOP - MainLine Health||Wynnewood, Pennsylvania 19096|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Baptist Regional Cancer Institute - Jacksonville||Jacksonville, Florida 32207|
|Cancer Research Center of Hawaii||Honolulu, Hawaii 96813|
|MBCCOP - Gulf Coast||Mobile, Alabama 36688|
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|CCOP - Northwest||Tacoma, Washington 98405-0986|
|Puget Sound Oncology Consortium||Seattle, Washington 98109|
|Hartford Hospital||Hartford, Connecticut 06102-5037|
|Sarasota Memorial Hospital||Sarasota, Florida 34239|
|MBCCOP-Cook County Hospital||Chicago, Illinois 60612|
|Eastern Maine Medical Center||Bangor, Maine 04401|
|Franklin Square Hospital Center||Baltimore, Maryland 21237|
|Michigan State University||East Lansing, Michigan 48824|
|Allegheny General Hospital||Pittsburgh, Pennsylvania 15212-4772|
|Utah Valley Regional Medical Center - Provo||Provo, Utah 84604|
|Virginia Oncology Associates - Newport News||Newport News, Virginia 23606|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego||San Diego, California 92120|
|University of Massachusetts Memorial Medical Center - University Campus||Worcester, Massachusetts 01655|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|CCOP - Beaumont||Royal Oak, Michigan 48073-6769|
|Cancer Research Center at Boston Medical Center||Boston, Massachusetts 02118|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|Stanford Cancer Center at Stanford University Medical Center||Stanford, California 94305|
|Loma Linda University Cancer Institute at Loma Linda University Medical Center||Loma Linda, California 92354|
|Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha||Omaha, Nebraska 68114-4199|
|Aultman Hospital Cancer Center at Aultman Health Foundation||Canton, Ohio 44710-1799|
|Vermont Cancer Center at University of Vermont||Burlington, Vermont 05405-0075|
|MBCCOP - Howard University Cancer Center||Washington, District of Columbia 20060|
|Creticos Cancer Center at Advocate Illinois Masonic Medical Center||Chicago, Illinois 60657|
|Providence Cancer Institute at Providence Hospital||Southfield, Michigan 48075|
|University of Miami Sylvester Cancer Center||Miami, Florida 33136|
|Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans||New Orleans, Louisiana 70112|
|Tulane University Medical Center||New Orleans, Louisiana 70112|
|New York Oncology Hematology, P.C. - Albany Regional Cancer Center||Albany, New York 12208|
|Jewish Hospital of Cincinnati, Incorporated||Cincinnati, Ohio 45236|
|Sutter Breast Cancer Group||Sacramento, California 95819-5156|
|Camcare Health||Charleston, West Virginia 25304|