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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 InstituteBuffalo, New York  14263
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
University of Colorado Cancer CenterDenver, Colorado  80262
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of Washington Medical CenterSeattle, Washington  98195-6043
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Sarah Cannon-Minnie Pearl Cancer CenterNashville, Tennessee  37203
Loyola University Medical CenterMaywood, Illinois  60153
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Lombardi Cancer CenterWashington, District of Columbia  20007
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
Bayfront Medical CenterSaint Petersburg, Florida  33701
James Graham Brown Cancer CenterLouisville, Kentucky  40202
McLaren Regional Cancer CenterFlint, Michigan  48432
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
University of Texas Medical BranchGalveston, Texas  77555-1329
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - EvanstonEvanston, Illinois  60201
John Wayne Cancer InstituteSanta Monica, California  90404
Evanston Northwestern Health CareEvanston, Illinois  60201
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
University of Rochester Medical CenterRochester, New York  14642
Norton Healthcare SystemLouisville, Kentucky  40202-5070
Lahey Clinic - BurlingtonBurlington, Massachusetts  01805
Kent County Memorial HospitalWarwick, Rhode Island  02886
Tallahassee Memorial HealthcareTallahassee, Florida  32308
University of California Davis Cancer CenterSacramento, California  95817
University of Missouri-Columbia Hospital and ClinicsColumbia, Missouri  65212
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
St. Joseph Hospital - OrangeOrange, California  92868
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
University of Connecticut Health CenterFarmington, Connecticut  06360-7106
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Central Baptist HospitalLexington, Kentucky  40503
Fox Chase Virtua Health Cancer Program at Virtua Memorial HospitalMount Holly, New Jersey  08060
York Cancer CenterYork, Pennsylvania  17403
Latter Day Saints HospitalSalt Lake City, Utah  84143
Texas Cancer Center at Brackenridge HospitalAustin, Texas  78701
Toledo HospitalToledo, Ohio  43606
Summit Medical CenterOakland, California  94609
Baylor University Medical CenterDallas, Texas  75246
Morton Plant Mease Health CareClearwater, Florida  33756
Highland Hospital of RochesterRochester, New York  14620
Park Nicollet ClinicSt. Louis Park, Minnesota  55416
Anne Arundel Medical CenterAnnapolis, Maryland  21401
Washington Regional Medical CenterFayetteville, Arkansas  72703
Woman's HospitalBaton Rouge, Louisiana  70815
St. Francis Medical CenterHonolulu, Hawaii  96817
Huntington Memorial HospitalPasadena, California  91109-7013
Tri-Health Good Samaritan HospitalCincinnati, Ohio  45220
Providence Hospital - Mobile ALMobile, Alabama  36685
Baptist Health Medical CenterLittle Rock, Arkansas  72205-7200
St. Vincent Doctors Doctors HospitalLittle Rock, Arkansas  72205-5331
Donald N. Sharp Memorial Community HospitalSan Diego, California  92123
Watson ClinicLakeland, Florida  33805
Lakeland Regional Medical CenterLakeland, Florida  33804
Martin Memorial Cancer Medical CenterStuart, Florida  34995
DeKalb Medical Center, Inc.Decatur, Georgia  30033
Kaiser Permanente Medical CenterHonolulu, Hawaii  96819
St. Luke's Regional Medical CenterBoise, Idaho  83712
Belleville Memorial HospitalBelleville, Illinois  62226-5399
St. Elizabeth's HospitalBelleville, Illinois  62220-1998
Northwestern University Medical CenterChicago, Illinois  60611
Little Company of Mary Hospital - Evergreen ParkEvergreen Park, Illinois  60805-2746
Saint Anthony Memorial Health Center - Michigan City CampusMichigan City, Indiana  46360
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Spectrum Health - Butterworth CampusGrand Rapids, Michigan  49546
Henry Ford Medical Center - West BloomfieldWest Bloomfield, Michigan  48322
Singing River HospitalPascagoula, Mississippi  39581
Columbia Regional HospitalColumbia, Missouri  65201
Lester E. Cox Medical CentersSpringfield, Missouri  65807-1988
Lutheran Medical CenterBrooklyn, New York  11220
Benedictine HospitalKingston, New York  12401
Kingston HospitalKingston, New York  12401-4692
St. Luke's-Roosevelt Hospital Center - Roosevelt DivisionNew York, New York  10019
Durham Regional HospitalDurham, North Carolina  27704-2763
Sacred Heart HospitalAllentown, Pennsylvania  18102
Baptist HospitalNashville, Tennessee  37236
St. Paul University HospitalDallas, Texas  75235
Zale Lipshy University HospitalDallas, Texas  75235-7786
Ben Taub General HospitalHouston, Texas  77030
Methodist HospitalHouston, Texas  77030
Carilion New River Valley Medical CenterChristiansburg, Virginia  24073
Carilion Health System - Cancer Center of Western VirginiaRoanoke, Virginia  24033
Columbia Lewis-Gale Medical CenterSalem, Virginia  24153
Froedtert Memorial Lutheran HospitalMilwaukee, Wisconsin  53226
Aurora Sinai Medical CenterMilwaukee, Wisconsin  53201-0342