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A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node


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

Thank you

Trial Information

A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node


OBJECTIVES:

- Determine whether axillary lymph node dissection (ALND) improves overall survival in
women with stage I or IIA breast cancer.

- Quantify and compare surgical morbidities associated with sentinel lymph node
dissection with or without ALND in these patients.

OUTLINE: This is a randomized study. After segmental mastectomy and sentinel lymph node
dissection, patients are stratified according to age (50 and under vs over 50), estrogen
receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than
1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two
treatment arms.

- Arm I: Patients undergo axillary lymph node dissection involving removal of at least
level I and II nodes, followed by whole-breast radiotherapy (exclusive of a third
supraclavicular field) 5 days a week for a maximum of 7 weeks.

- Arm II: Patients undergo breast radiotherapy only as in arm I. Patients in both arms
may receive adjuvant systemic therapy at the discretion of the treating physician.

Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for
a total of 10 years.

PROJECTED ACCRUAL: Approximately 1,900 patients (950 per treatment arm) will be accrued for
this study within 3.8 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage I or IIA (T1 or T2, N0, M0) invasive breast carcinoma
amenable to lumpectomy

- Tumor must be less than 5 cm

- No palpable nodes

- No evidence of metastatic disease

- Cytologic diagnosis suggestive of carcinoma from a fine-needle aspiration from a
palpable or nonpalpable breast lesion and clinically suspicious for invasive
breast carcinoma allowed

- No concurrent bilateral breast malignancies

- Diagnosis no more than 60 days prior to sentinel lymph node dissection (SLND)

- Sentinel node must have been identified and found to contain metastatic disease

- No matted lymph nodes or gross extranodal disease

- No more than 2 positive sentinel nodes

- No clinically or radiologically identified multifocal disease not amenable to a
single lumpectomy

- Hormone receptor status:

- Estrogen receptor positive or negative

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- ECOG (Zubrod) 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Must not be considered a poor surgical risk due to any other nonmalignant systemic
disease

- No other prior malignancies within the past 5 years except successfully treated basal
cell or squamous cell skin cancer or surgically treated carcinoma in situ of the
cervix or lobular carcinoma in situ of the ipsilateral or contralateral breast

- All prior malignancies must have been curatively treated and risk of recurrence must
be low

- Not pregnant or nursing

- Negative pregnancy test

- No other medical condition contraindicating axillary lymph node dissection or
postoperative breast radiotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for this breast cancer

Endocrine therapy:

- No prior estrogen receptor antagonist (i.e., tamoxifen) or selective estrogen
receptor modulators therapy (i.e., raloxifene) for this breast cancer

Radiotherapy:

- Not specified

Surgery:

- Prior breast-conserving therapy (i.e., segmental mastectomy) allowed if no more than
60 days prior to SLND

- No pre-pectoral breast implant

- Subpectoral implant allowed

- No prior ipsilateral axillary surgery (e.g., excisional biopsy of the lymph nodes or
treatment of hidradenitis)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

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:

CDR0000067018

NCT ID:

NCT00003855

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
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Abington Memorial HospitalAbington, Pennsylvania  19001
Medical City Dallas HospitalDallas, Texas  75230
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
United HospitalSt. Paul, Minnesota  55102
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
Maine Medical CenterPortland, Maine  04102
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
University of Texas Medical BranchGalveston, Texas  77555-1329
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Dixie Regional Medical CenterSaint George, Utah  84770
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
University of California Davis Cancer CenterSacramento, California  95817
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
St. Louis University Hospital Cancer CenterSaint Louis, Missouri  63110
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Evanston Northwestern Health Care - Evanston HospitalEvanston, Illinois  60201
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
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
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Toledo HospitalToledo, Ohio  43606
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Mount Nittany Medical CenterState College, Pennsylvania  16803
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
Arthur G. James Cancer Hospital at Ohio State UniversityColumbus, Ohio  43210-1240
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Butterworth HospitalGrand Rapids, Michigan  49503
Simmons Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390-9063
Summit Medical CenterOakland, California  94609
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Baylor University Medical CenterDallas, Texas  75246
Hope A Women's Cancer CenterAsheville, North Carolina  28801
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Mount Diablo Regional Cancer CenterConcord, California  94524-4110
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Highland Hospital of RochesterRochester, New York  14620
Good Samaritan HospitalDayton, Ohio  45406
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Providence St. Vincent Medical CenterPortland, Oregon  97225
Doctor's Hospital of LaredoLaredo, Texas  78041
Baton Rouge General Regional Cancer CenterBaton Rouge, Louisiana  70821
DeCesaris Cancer Institute at Anne Arundel Medical CenterAnnapolis, Maryland  21401
Park Nicollet ClinicSt. Louis Park, Minnesota  55416
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
Palo Alto Medical FoundationPalo Alto, California  94301
St. Francis Hospital and Health CentersBeech Grove, Indiana  46107
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Louis Busch Hager Cancer Center at Mary Imogene Bassett HospitalCooperstown, New York  13326
Miami Valley HospitalDayton, Ohio  45409
John and Dorothy Morgan Cancer Center at Lehigh Valley HospitalAllentown, Pennsylvania  18105
Vince Lombardi Cancer Clinic at St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Washington Regional Medical CenterFayetteville, Arkansas  72703
Woman's HospitalBaton Rouge, Louisiana  70815
St. Francis Medical CenterHonolulu, Hawaii  96817
Morton Plant HospitalClearwater, Florida  33756
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985
Norton Healthcare Cancer CenterLouisville, Kentucky  40202-5070
Huntington Cancer Center at Huntington HospitalPasadena, California  91105
Alexian Brothers Medical CenterElk Grove Village, Illinois  60007
Tri-Health Good Samaritan HospitalCincinnati, Ohio  45220
Baptist Health Medical CenterLittle Rock, Arkansas  72205-7200
St. Vincent Doctors Doctors HospitalLittle Rock, Arkansas  72205-5331
Watson ClinicLakeland, Florida  33805
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
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Henry Ford Medical Center - West BloomfieldWest Bloomfield, Michigan  48322
Lutheran Medical CenterBrooklyn, New York  11220
Kingston HospitalKingston, New York  12401-4692
Sacred Heart HospitalAllentown, Pennsylvania  18102
Baptist HospitalNashville, Tennessee  37236
St. Paul University HospitalDallas, Texas  75235
Zale Lipshy University HospitalDallas, Texas  75235-7786
Carilion New River Valley Medical CenterChristiansburg, Virginia  24073
Carilion Health System - Cancer Center of Western VirginiaRoanoke, Virginia  24033
Providence Cancer CenterMobile, Alabama  36608
Mercy San Juan HospitalCarmichael, California  95608
Arrowhead Regional Medical CenterColton, California  92324-1819
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Shasta Regional Medical CenterRedding, California  96001-0853
Sharp Memorial HospitalSan Diego, California  92123
John Wayne Cancer Institute at Saint John's Health CenterSanta Monica, California  90404
Sonoma Valley HospitalSonoma, California  95476
St. Joseph's Regional Cancer CenterStockton, California  95204
Martin Memorial Cancer CenterStuart, Florida  34995-9010
Phoebe Cancer Center at Phoebe Putney Memorial HospitalAlbany, Georgia  31702
Albany, Georgia  31701
Surgical Oncology of Northeast GeorgiaGainesville, Georgia  30501
Deaconess HospitalEvansville, Indiana  47747
St. Mary's Medical CenterEvansville, Indiana  47750
Fallon Clinic at Worcester Medical CenterWorcester, Massachusetts  01608
Great Lakes Cancer Institute - McLarenFlint, Michigan  48532
Spectrum Health - Blodgett CampusGrand Rapids, Michigan  49506
Spectrum Health Downtown CampusGrand Rapids, Michigan  49503
Southern New Hampshire Medical CenterNashua, New Hampshire  03061-2014
Comprehensive Cancer Center at Our Lady of Mercy Medical CenterBronx, New York  10466
Fern Feldman Anolick Breast Center at Benedictine HospitalKingston, New York  12401
Flower Hospital - ProMedica Health SystemSylvania, Ohio  43560
Greene Memorial HospitalXenia, Ohio  45385
Kaiser Permanente Medical Office - Mother Joseph PlazaPortland, Oregon  97225
Easton HospitalEaston, Pennsylvania  18042
Williamsport HospitalWilliamsport, Pennsylvania  17701-1995
Avera Sacred Heart HospitalYankton, South Dakota  57078
Baptist Cancer Institute at Baptist Memorial Hospital - MemphisMemphis, Tennessee  38120
Sarah Cannon Cancer Center at Centennial Medical CenterNashville, Tennessee  37203
Seton Shivers Cancer Program at Brackenridge HospitalAustin, Texas  78701
Parkland Health and Hospital SystemDallas, Texas  75235-7786
Southwest Cancer and Research Center at University Medical CenterLubbock, Texas  79415-3364
INOVA Fair Oaks HospitalFairfax, Virginia  22033