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A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Armando E. Giuliano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

John Wayne Cancer Institute at Saint John's Health Center

Authority:

United States: Federal Government

Study ID:

CDR0000067017

NCT ID:

NCT00003854

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • Breast Neoplasms

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