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	Treatment or Intervention	Phase
stage I breast cancer stage II breast cancer	Procedure: conventional surgery  Procedure: diagnostic test  Procedure: immunohistochemistry  Procedure: lymphography  Procedure: radiation therapy  Procedure: sentinel node biopsy  Procedure: surgery	Phase III

Further Study Details: 

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 thereafter.

PROJECTED ACCRUAL: A total of 5,300 patients will be accrued for this study within an additional 3 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage I or IIA (T1 or T2 N0 M0) invasive breast carcinoma diagnosed within 60 days of sentinel lymph node dissection
• Cytologic diagnosis suggestive of carcinoma from a fine needle aspiration of a palpable or nonpalpable breast lesion allowed if clinically suspicious for invasive breast carcinoma
• Tumor must be amenable to segmental mastectomy (lumpectomy)
• No clinically and radiologically identified multicentric disease that is not amenable to a single lumpectomy
• No concurrent bilateral invasive breast malignancies
• No tumors in the medial hemisphere of the breast that show complete absence of drainage to the axilla by lymphoscintigram
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age:

• Over 18

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2 OR
• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• No renal disease that would increase surgical risk

Cardiovascular:

• No cardiovascular disease that would increase surgical risk

Other:

• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, surgically treated carcinoma in situ of the cervix, or curatively treated lobular carcinoma in situ of the ipsilateral or contralateral breast with a low risk of recurrence
• No other nonmalignant systemic disease that would increase surgical risk
• No active connective tissue disorders
• Able to undergo and have access to radiotherapy
• Physically able to undergo bilateral anterior iliac crest bone marrow aspiration
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for invasive breast cancer

Endocrine therapy:

• No prior estrogen-receptor antagonists (e.g., tamoxifen) or selective estrogen-receptor modulators (e.g., raloxifene) for invasive breast cancer

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics
• No prior ipsilateral axillary surgery (e.g., excisional biopsy of lymph nodes or treatment of hidradenitis)
• No pre-pectoral breast implant
• Subpectoral implant allowed

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

Study chairs or principal investigators

Armando E. Giuliano, MD,  Study Chair,  John Wayne Cancer Institute   

Study ID Numbers:  CDR0000067017; ACOSOG-Z0010; GUMC-00152
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003854
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08