Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003854
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 13, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer.

PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: immunohistochemistry staining method Procedure: lymphangiography Procedure: sentinel lymph node biopsy Procedure: therapeutic conventional surgery Radiation: whole breast irradiation Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4590 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer
Study Start Date : April 1999
Actual Primary Completion Date : August 2006
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Surgery + radiotherapy + adjuvant therapy

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.

Other: immunohistochemistry staining method
Procedure: lymphangiography
Procedure: sentinel lymph node biopsy
Procedure: therapeutic conventional surgery
Radiation: whole breast irradiation

Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 10 years ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: Up to 10 years ]
  2. Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND [ Time Frame: Up to 10 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient must be female.
  2. Patient's clinical stage must be I or II (T1 or T2 N0 M0) and the tumor must be amenable to segmental mastectomy (lumpectomy).
  3. Patient must have a tissue diagnosis of invasive breast carcinoma. Note: A patient can be registered to this study if they have a cytologic diagnosis suggestive of carcinoma from a fine needle aspiration (FNA) of a palpable or non-palpable breast lesion and the investigator believes the breast lesion is clinically suspicious for invasive breast carcinoma.
  4. The date of the patient's first tissue diagnosis of invasive breast carcinoma or cytologic diagnosis of breast carcinoma must be no more than 60 days prior to SLND.
  5. The patient who had segmental mastectomy (lumpectomy) performed previously, and is now referred to the local investigator for SLND, is eligible if the lumpectomy was less than or equal to 60 days prior to the SLND. Copies of the operative and pathology reports must be submitted as a part of the registration process.
  6. Patient must have ECOG/Zubrod status of ≤2, as documented in patient's medical record.
  7. Patient must be available for follow-up.
  8. The patient with a history of a previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided that the following criteria are met:

    1. The patient has undergone potentially curative therapy for all prior malignancies.
    2. There has been no evidence of any prior malignancies for at least five years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), and
    3. The patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
  9. Signed and dated informed consent is obtained prior to patient registration.
  10. Patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
  11. Patient must be able to physically undergo bilateral anterior iliac crest bone marrow aspiration.

Exclusion Criteria:

  1. Patient is lactating (breastfeeding).
  2. Patient has been previously treated with chemotherapy, estrogen receptor antagonists (i.e. Tamoxifen) or selective estrogen receptor modulators (SERMs, i.e. Raloxifene) for this invasive breast cancer.
  3. Patient has a previously placed pre-pectoral breast implant. NOTE: A subpectoral implant is allowed.
  4. Patient is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.), which would preclude the treatment options.
  5. Patient has concurrent bilateral invasive breast malignancies.
  6. Patient is not able to undergo and does not have access to radiation therapy as describedin Adjuvant Radiation Therapy in the Interventions section of the protocol.

    Patients with active connective tissue disorders and those that live too far from a radiation treatment center, for example, would not be eligible.

  7. Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.
  8. Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003854

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36640-0460
Providence Hospital - Mobile AL
Mobile, Alabama, United States, 36685
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Washington Regional Medical Center
Fayetteville, Arkansas, United States, 72703
St. Vincent Doctors Doctors Hospital
Little Rock, Arkansas, United States, 72205-5331
Baptist Health Medical Center
Little Rock, Arkansas, United States, 72205-7200
United States, California
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States, 90027
Summit Medical Center
Oakland, California, United States, 94609
St. Joseph Hospital - Orange
Orange, California, United States, 92868-3849
Huntington Memorial Hospital
Pasadena, California, United States, 91109-7013
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Donald N. Sharp Memorial Community Hospital
San Diego, California, United States, 92123
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0128
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-3955
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
Morton Plant Mease Health Care
Clearwater, Florida, United States, 33756
Lakeland Regional Medical Center
Lakeland, Florida, United States, 33804
Watson Clinic
Lakeland, Florida, United States, 33805
Bayfront Medical Center
Saint Petersburg, Florida, United States, 33701
Martin Memorial Cancer Medical Center
Stuart, Florida, United States, 34995
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States, 32308
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
DeKalb Medical Center, Inc.
Decatur, Georgia, United States, 30033
United States, Hawaii
St. Francis Medical Center
Honolulu, Hawaii, United States, 96817
Kaiser Permanente Medical Center
Honolulu, Hawaii, United States, 96819
United States, Idaho
St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712
United States, Illinois
St. Elizabeth's Hospital
Belleville, Illinois, United States, 62220-1998
Belleville Memorial Hospital
Belleville, Illinois, United States, 62226-5399
Northwestern University Medical Center
Chicago, Illinois, United States, 60611
CCOP - Evanston
Evanston, Illinois, United States, 60201
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Little Company of Mary Hospital - Evergreen Park
Evergreen Park, Illinois, United States, 60805-2746
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Saint Anthony Memorial Health Center - Michigan City Campus
Michigan City, Indiana, United States, 46360
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
Norton Healthcare System
Louisville, Kentucky, United States, 40202-5070
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70815
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70821-2511
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Lahey Clinic - Burlington
Burlington, Massachusetts, United States, 01805
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Henry Ford Hospital
Detroit, Michigan, United States, 48202
McLaren Regional Cancer Center
Flint, Michigan, United States, 48432
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439-8066
Spectrum Health - Butterworth Campus
Grand Rapids, Michigan, United States, 49546
Henry Ford Medical Center - West Bloomfield
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
Park Nicollet Clinic
St. Louis Park, Minnesota, United States, 55416
United States, Mississippi
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Columbia Regional Hospital
Columbia, Missouri, United States, 65201
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States, 65212
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-2500
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Lester E. Cox Medical Centers
Springfield, Missouri, United States, 65807-1988
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States, 08060
United States, New York
Lutheran Medical Center
Brooklyn, New York, United States, 11220
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Kingston Hospital
Kingston, New York, United States, 12401-4692
Benedictine Hospital
Kingston, New York, United States, 12401
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
New York, New York, United States, 10019
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Highland Hospital of Rochester
Rochester, New York, United States, 14620
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Durham Regional Hospital
Durham, North Carolina, United States, 27704-2763
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Cape Fear Valley Health System
Fayetteville, North Carolina, United States, 28302-2000
United States, Ohio
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, United States, 90027
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1228
Toledo Hospital
Toledo, Ohio, United States, 43606
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Sacred Heart Hospital
Allentown, Pennsylvania, United States, 18102
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
York Cancer Center
York, Pennsylvania, United States, 17403
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Kent County Memorial Hospital
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Baptist Hospital
Nashville, Tennessee, United States, 37236
United States, Texas
Texas Cancer Center at Brackenridge Hospital
Austin, Texas, United States, 78701
Zale Lipshy University Hospital
Dallas, Texas, United States, 75235-7786
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
St. Paul University Hospital
Dallas, Texas, United States, 75235
Baylor University Medical Center
Dallas, Texas, United States, 75246
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0542
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Ben Taub General Hospital
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84132
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Carilion New River Valley Medical Center
Christiansburg, Virginia, United States, 24073
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Carilion Health System - Cancer Center of Western Virginia
Roanoke, Virginia, United States, 24033
Columbia Lewis-Gale Medical Center
Salem, Virginia, United States, 24153
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53201-0342
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215-5166
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Australia, Victoria
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia, 8006
Cork University Hospital
Cork, Ireland
St. Vincent's University Hospital
Dublin, Ireland, 4
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Armando E. Giuliano, MD John Wayne Cancer Institute

Publications of Results:

Other Publications:
Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00003854     History of Changes
Other Study ID Numbers: ACOSOG-Z0010
CDR0000067017 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases