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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 Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Abington Memorial Hospital Abington, Pennsylvania  19001
Medical City Dallas Hospital Dallas, Texas  75230
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
United Hospital St. Paul, Minnesota  55102
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Huntsman Cancer Institute Salt Lake City, Utah  84112
Memorial Hospital Cancer Center Colorado Springs, Colorado  80909
Maine Medical Center Portland, Maine  04102
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
Dixie Regional Medical Center Saint George, Utah  84770
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
Keesler Medical Center - Keesler Air Force Base Keesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
UPMC Cancer Center at Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
University of California Davis Cancer Center Sacramento, California  95817
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
West Virginia University Hospitals Morgantown, West Virginia  26506-9300
City of Hope Comprehensive Cancer Center Duarte, California  91010
UCSF Comprehensive Cancer Center San Francisco, California  94115
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
St. Louis University Hospital Cancer Center Saint Louis, Missouri  63110
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Evanston Northwestern Health Care - Evanston Hospital Evanston, Illinois  60201
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University Cleveland, Ohio  44106
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
St. Luke's Hospital Cancer Center Bethlehem, Pennsylvania  18015
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Toledo Hospital Toledo, Ohio  43606
Baylor University Medical Center - Houston Houston, Texas  77030-2399
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Mount Nittany Medical Center State College, Pennsylvania  16803
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Lombardi Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Josephine Ford Cancer Center at Henry Ford Health System Detroit, Michigan  48202
Arthur G. James Cancer Hospital at Ohio State University Columbus, Ohio  43210-1240
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Butterworth Hospital Grand Rapids, Michigan  49503
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390-9063
Summit Medical Center Oakland, California  94609
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Baylor University Medical Center Dallas, Texas  75246
Hope A Women's Cancer Center Asheville, North Carolina  28801
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Lakeland, Florida  33805
Mount Diablo Regional Cancer Center Concord, California  94524-4110
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Highland Hospital of Rochester Rochester, New York  14620
Good Samaritan Hospital Dayton, Ohio  45406
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Providence St. Vincent Medical Center Portland, Oregon  97225
Doctor's Hospital of Laredo Laredo, Texas  78041
Baton Rouge General Regional Cancer Center Baton Rouge, Louisiana  70821
DeCesaris Cancer Institute at Anne Arundel Medical Center Annapolis, Maryland  21401
Park Nicollet Clinic St. Louis Park, Minnesota  55416
CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale, Arizona  85259
Palo Alto Medical Foundation Palo Alto, California  94301
St. Francis Hospital and Health Centers Beech Grove, Indiana  46107
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital Cooperstown, New York  13326
Miami Valley Hospital Dayton, Ohio  45409
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital Allentown, Pennsylvania  18105
Vince Lombardi Cancer Clinic at St. Luke's Medical Center Milwaukee, Wisconsin  53215
Washington Regional Medical Center Fayetteville, Arkansas  72703
Woman's Hospital Baton Rouge, Louisiana  70815
St. Francis Medical Center Honolulu, Hawaii  96817
Morton Plant Hospital Clearwater, Florida  33756
John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois  60612-9985
Norton Healthcare Cancer Center Louisville, Kentucky  40202-5070
Huntington Cancer Center at Huntington Hospital Pasadena, California  91105
Alexian Brothers Medical Center Elk Grove Village, Illinois  60007
Tri-Health Good Samaritan Hospital Cincinnati, Ohio  45220
Baptist Health Medical Center Little Rock, Arkansas  72205-7200
St. Vincent Doctors Doctors Hospital Little Rock, Arkansas  72205-5331
Watson Clinic Lakeland, Florida  33805
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
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
Henry Ford Medical Center - West Bloomfield West Bloomfield, Michigan  48322
Lutheran Medical Center Brooklyn, New York  11220
Kingston Hospital Kingston, New York  12401-4692
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
Carilion New River Valley Medical Center Christiansburg, Virginia  24073
Carilion Health System - Cancer Center of Western Virginia Roanoke, Virginia  24033
Providence Cancer Center Mobile, Alabama  36608
Mercy San Juan Hospital Carmichael, California  95608
Arrowhead Regional Medical Center Colton, California  92324-1819
St. Joseph Hospital Regional Cancer Center - Orange Orange, California  92868-3849
Shasta Regional Medical Center Redding, California  96001-0853
Sharp Memorial Hospital San Diego, California  92123
John Wayne Cancer Institute at Saint John's Health Center Santa Monica, California  90404
Sonoma Valley Hospital Sonoma, California  95476
St. Joseph's Regional Cancer Center Stockton, California  95204
Martin Memorial Cancer Center Stuart, Florida  34995-9010
Phoebe Cancer Center at Phoebe Putney Memorial Hospital Albany, Georgia  31702
Albany, Georgia  31701
Surgical Oncology of Northeast Georgia Gainesville, Georgia  30501
Deaconess Hospital Evansville, Indiana  47747
St. Mary's Medical Center Evansville, Indiana  47750
Fallon Clinic at Worcester Medical Center Worcester, Massachusetts  01608
Great Lakes Cancer Institute - McLaren Flint, Michigan  48532
Spectrum Health - Blodgett Campus Grand Rapids, Michigan  49506
Spectrum Health Downtown Campus Grand Rapids, Michigan  49503
Southern New Hampshire Medical Center Nashua, New Hampshire  03061-2014
Comprehensive Cancer Center at Our Lady of Mercy Medical Center Bronx, New York  10466
Fern Feldman Anolick Breast Center at Benedictine Hospital Kingston, New York  12401
Flower Hospital - ProMedica Health System Sylvania, Ohio  43560
Greene Memorial Hospital Xenia, Ohio  45385
Kaiser Permanente Medical Office - Mother Joseph Plaza Portland, Oregon  97225
Easton Hospital Easton, Pennsylvania  18042
Williamsport Hospital Williamsport, Pennsylvania  17701-1995
Avera Sacred Heart Hospital Yankton, South Dakota  57078
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis Memphis, Tennessee  38120
Sarah Cannon Cancer Center at Centennial Medical Center Nashville, Tennessee  37203
Seton Shivers Cancer Program at Brackenridge Hospital Austin, Texas  78701
Parkland Health and Hospital System Dallas, Texas  75235-7786
Southwest Cancer and Research Center at University Medical Center Lubbock, Texas  79415-3364
INOVA Fair Oaks Hospital Fairfax, Virginia  22033