A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer
OBJECTIVES:
- Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node
micrometastases detected by immunohistochemistry in women with stage I or IIA breast
cancer.
- Estimate the prevalence and evaluate the prognostic significance of bone marrow
micrometastases detected by immunocytochemistry in these patients.
- Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are
negative by hematoxylin and eosin (H&E) staining.
- Provide a mechanism for identifying women whose sentinel nodes contain metastases
detected by H&E so that these women can be considered as candidates for ACOSOG-Z0011.
OUTLINE: Patients undergo bilateral anterior iliac crest bone marrow aspiration to test for
presence of micrometastases. Patients then undergo breast-conserving therapy comprising
segmental mastectomy and sentinel lymph node dissection (SLND) with planned postoperative
whole-breast radiotherapy and systemic adjuvant therapy. The SLND comprises ipsilateral
axillary sentinel node identification and histopathology.
Patients with no sentinel node identified intraoperatively and patients with sentinel node
metastasis identified by hematoxylin and eosin (H&E) who choose not to be registered to
ACOSOG-Z0011 undergo axillary lymph node dissection involving removal of at least level I
and II nodes.
All patients undergo whole-breast radiotherapy (excluding a supraclavicular field) 5 days a
week for a maximum of 8 weeks.
Patients are followed at 30 days; at 6, 12, 18, 24, 30, and 36 months; and then annually
until 10 years after surgery.
PROJECTED ACCRUAL: A total of 5,300 patients will be accrued for this study within an
additional 3 years.
Interventional
Primary Purpose: Diagnostic
Armando E. Giuliano, MD
Study Chair
John Wayne Cancer Institute at Saint John's Health Center
United States: Federal Government
CDR0000067017
NCT00003854
April 1999
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Sarah Cannon-Minnie Pearl Cancer Center | Nashville, Tennessee 37203 |
Loyola University Medical Center | Maywood, Illinois 60153 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Kaiser Permanente Medical Center - Los Angeles | Los Angeles, California 90027 |
Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
Bayfront Medical Center | Saint Petersburg, Florida 33701 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
McLaren Regional Cancer Center | Flint, Michigan 48432 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15219 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Evanston | Evanston, Illinois 60201 |
John Wayne Cancer Institute | Santa Monica, California 90404 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
University of Rochester Medical Center | Rochester, New York 14642 |
Norton Healthcare System | Louisville, Kentucky 40202-5070 |
Lahey Clinic - Burlington | Burlington, Massachusetts 01805 |
Kent County Memorial Hospital | Warwick, Rhode Island 02886 |
Tallahassee Memorial Healthcare | Tallahassee, Florida 32308 |
University of California Davis Cancer Center | Sacramento, California 95817 |
University of Missouri-Columbia Hospital and Clinics | Columbia, Missouri 65212 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
St. Joseph Hospital - Orange | Orange, California 92868 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Cape Fear Valley Health System | Fayetteville, North Carolina 28302-2000 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
University of Connecticut Health Center | Farmington, Connecticut 06360-7106 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | Mount Holly, New Jersey 08060 |
York Cancer Center | York, Pennsylvania 17403 |
Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
Texas Cancer Center at Brackenridge Hospital | Austin, Texas 78701 |
Toledo Hospital | Toledo, Ohio 43606 |
Summit Medical Center | Oakland, California 94609 |
Baylor University Medical Center | Dallas, Texas 75246 |
Morton Plant Mease Health Care | Clearwater, Florida 33756 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Park Nicollet Clinic | St. Louis Park, Minnesota 55416 |
Anne Arundel Medical Center | Annapolis, Maryland 21401 |
Washington Regional Medical Center | Fayetteville, Arkansas 72703 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
St. Francis Medical Center | Honolulu, Hawaii 96817 |
Huntington Memorial Hospital | Pasadena, California 91109-7013 |
Tri-Health Good Samaritan Hospital | Cincinnati, Ohio 45220 |
Providence Hospital - Mobile AL | Mobile, Alabama 36685 |
Baptist Health Medical Center | Little Rock, Arkansas 72205-7200 |
St. Vincent Doctors Doctors Hospital | Little Rock, Arkansas 72205-5331 |
Donald N. Sharp Memorial Community Hospital | San Diego, California 92123 |
Watson Clinic | Lakeland, Florida 33805 |
Lakeland Regional Medical Center | Lakeland, Florida 33804 |
Martin Memorial Cancer Medical Center | Stuart, Florida 34995 |
DeKalb Medical Center, Inc. | Decatur, Georgia 30033 |
Kaiser Permanente Medical Center | Honolulu, Hawaii 96819 |
St. Luke's Regional Medical Center | Boise, Idaho 83712 |
Belleville Memorial Hospital | Belleville, Illinois 62226-5399 |
St. Elizabeth's Hospital | Belleville, Illinois 62220-1998 |
Northwestern University Medical Center | Chicago, Illinois 60611 |
Little Company of Mary Hospital - Evergreen Park | Evergreen Park, Illinois 60805-2746 |
Saint Anthony Memorial Health Center - Michigan City Campus | Michigan City, Indiana 46360 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana 70821-2511 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Spectrum Health - Butterworth Campus | Grand Rapids, Michigan 49546 |
Henry Ford Medical Center - West Bloomfield | West Bloomfield, Michigan 48322 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
Columbia Regional Hospital | Columbia, Missouri 65201 |
Lester E. Cox Medical Centers | Springfield, Missouri 65807-1988 |
Lutheran Medical Center | Brooklyn, New York 11220 |
Benedictine Hospital | Kingston, New York 12401 |
Kingston Hospital | Kingston, New York 12401-4692 |
St. Luke's-Roosevelt Hospital Center - Roosevelt Division | New York, New York 10019 |
Durham Regional Hospital | Durham, North Carolina 27704-2763 |
Sacred Heart Hospital | Allentown, Pennsylvania 18102 |
Baptist Hospital | Nashville, Tennessee 37236 |
St. Paul University Hospital | Dallas, Texas 75235 |
Zale Lipshy University Hospital | Dallas, Texas 75235-7786 |
Ben Taub General Hospital | Houston, Texas 77030 |
Methodist Hospital | Houston, Texas 77030 |
Carilion New River Valley Medical Center | Christiansburg, Virginia 24073 |
Carilion Health System - Cancer Center of Western Virginia | Roanoke, Virginia 24033 |
Columbia Lewis-Gale Medical Center | Salem, Virginia 24153 |
Froedtert Memorial Lutheran Hospital | Milwaukee, Wisconsin 53226 |
Aurora Sinai Medical Center | Milwaukee, Wisconsin 53201-0342 |