RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the uptake of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of anastrozole to that of tamoxifen after lumpectomy in preventing the recurrence of breast cancer in postmenopausal women who have ductal carcinoma in situ and are undergoing radiation therapy.

Condition	Treatment or Intervention	Phase
breast cancer in situ intraductal breast carcinoma	Drug: anastrozole  Drug: tamoxifen  Procedure: adjuvant therapy  Procedure: antiestrogen therapy  Procedure: aromatase inhibition  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: radiation therapy	Phase III

OBJECTIVES:

• Compare the value of anastrozole vs tamoxifen, in terms of preventing recurrence (i.e., local, regional, and distant recurrences and contralateral breast cancer), after lumpectomy and radiotherapy in postmenopausal women with ductal carcinoma in situ (DCIS).
• Compare subsequent disease occurrence, in terms of invasive breast cancer (local, regional, distant, or contralateral), ipsilateral and contralateral breast cancer (invasive and DCIS), and non-breast second primary malignancies, in patients treated with these drugs.
• Compare quality of life and symptoms of patients treated with these drugs.
• Compare quality-adjusted survival time of patients treated with these drugs.
• Compare the occurrence of osteoporotic fractures in patients treated with these drugs.
• Compare disease-free and overall survival of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (under 60 vs 60 and over). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral tamoxifen and oral placebo once daily for 5 years.
• Arm II: Patients receive oral anastrozole and oral placebo once daily for 5 years. All patients also undergo whole breast radiotherapy beginning within 8 weeks of randomization.

Quality of life is assessed at baseline and then every 6 months for 6 years.

Patients are followed every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 5 years.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
• Mixed DCIS and lobular carcinoma in situ allowed
• Must have undergone lumpectomy
• Margins must be histologically free of disease
• Re-excision to obtain tumor-free margins allowed
• No more than 84 days since prior lumpectomy or re-excision
• More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins
• Masses or clusters of calcification that are clinically or mammographically suspicious must be biopsied
• No prior DCIS
• No prior or concurrent invasive (including microinvasive) breast cancer
• DCIS "suspicious" for microinvasion allowed
• No bilateral malignancy
• No mass or mammographic abnormality suspicious for malignancy in the opposite breast unless not malignant as proven by biopsy
• No positive ipsilateral axillary or intramammary nodes
• No palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes unless not involved with tumor as proven by biopsy
• Hormone receptor status:
• Estrogen- or progesterone-receptor positive as determined by immunohistochemistry
• Borderline results are considered positive

PATIENT CHARACTERISTICS: Age

• See Menopausal status

Sex:

• Female

Menopausal status:

• Postmenopausal as defined by at least 1 of the following:
• Prior documented bilateral oophorectomy
• At least 12 months without spontaneous bleeding
• Age 55 or over with prior hysterectomy without oophorectomy
• Age 54 or under with prior hysterectomy without oophorectomy with a documented follicle-stimulating hormone level in the postmenopausal range

Performance status

• Zubrod 0-2

Life expectancy

• At least 10 years (excluding diagnosis of breast cancer)

Hematopoietic

• WBC normal

Hepatic

• AST normal
• Bilirubin normal
• Alkaline phosphatase normal
• No hepatic disease that would preclude administration of study drugs

Renal

• Creatinine normal
• No renal disease that would preclude administration of study drugs

Cardiovascular

• No prior documented cerebral vascular accident or transient ischemic attack
• No prior deep vein thrombosis
• No cardiovascular disease that would preclude administration of study drugs
• No uncontrolled hypertension (i.e., systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg based on the average of 2 or more readings at each of 2 or more visits after initial screening)
• No uncontrolled atrial fibrillation

Pulmonary

• No pulmonary embolus

Other

• Not pregnant or nursing
• No psychiatric or addictive disorders that would preclude informed consent
• No other non-breast malignancy within the past 5 years except:
• Effectively treated squamous cell or basal cell skin cancer
• Surgically treated carcinoma in situ of the cervix
• Surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast
• No uncontrolled diabetes defined as hemoglobin A1C greater than 9% (fasting glucose 200 mg/dL)
• No nonmalignant systemic disease that would preclude administration of study drugs

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• No prior or concurrent aromatase inhibitors (e.g., exemestane or letrozole) or tamoxifen
• No concurrent raloxifene or other selective estrogen receptor modulators
• No concurrent sex hormone therapy (e.g., estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone releasing hormone analogs, prolactin inhibitors, or antiandrogens)
• Low-dose estrogen vaginal creams or Estring allowed

Radiotherapy

• Radiotherapy for this cancer initiated before study is allowed
• No prior or concurrent partial breast or regional lymph node irradiation

Surgery

• See Disease Characteristics
• No prior or concurrent mastectomy for DCIS
• Prior sentinel node biopsy or axillary node dissection allowed provided nodes are pathologically negative

Other

• No concurrent warfarin
• No other systemic therapy for this cancer initiated before study
• No other concurrent anticancer therapy unless permitted by the protocol investigator
• No concurrent participation in another clinical trial of systemic therapy for DCIS

Alabama
      Comprehensive Cancer Institute, Huntsville,  Alabama,  35801,  United States; Recruiting
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36688,  United States; Recruiting
Alaska
      Providence Alaska Medical Center, Anchorage,  Alaska,  99519-6604,  United States; Recruiting
Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States; Recruiting
Arkansas
      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
      Veterans Affairs Medical Center - Little Rock, Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      California Cancer Center at Woodward Park Office, Fresno,  California,  93720,  United States; Recruiting
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States; Recruiting
      Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange,  California,  92868,  United States; Recruiting
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
      Comprehensive Cancer Center at Desert Regional Medical Center, Palm Springs,  California,  92262,  United States; Recruiting
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting
      Kaiser Permanente Medical Center - Vallejo, Vallejo,  California,  94589,  United States; Recruiting
      Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego,  California,  92120,  United States; Recruiting
      Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States; Recruiting
      Pacific Shores Medical Group Comprehensive Hematology–Oncology Services - Long Beach, Long Beach,  California,  90813,  United States; Recruiting
      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  United States; Recruiting
      Scripps Cancer Center at Scripps Clinic, La Jolla,  California,  92037,  United States; Recruiting
      Stanford Cancer Center at Stanford University Medical Center, Palo Alto,  California,  94305-1808,  United States; Recruiting
      Sutter Cancer Center, Sacramento,  California,  95816,  United States; Recruiting
      Sutter Health Western Division Cancer Research Group, Greenbrae,  California,  94904,  United States; Recruiting
      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States; Recruiting
Colorado
      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80224,  United States; Recruiting
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80010,  United States; Recruiting
      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States; Recruiting
Connecticut
      Helen and Harry Gray Cancer Center at Hartford Hospital, Hartford,  Connecticut,  06102-5037,  United States; Recruiting
      University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center, Farmington,  Connecticut,  06360-7106,  United States; Recruiting
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States; Recruiting
District of Columbia
      George Washington University Medical Center, Washington,  District of Columbia,  20037,  United States; Recruiting
      MBCCOP - Howard University Cancer Center, Washington,  District of Columbia,  20060,  United States; Recruiting
Florida
      Baptist Cancer Institute - Jacksonville, Jacksonville,  Florida,  32207,  United States; Recruiting
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States; Recruiting
      Halifax Medical Center, Daytona Beach,  Florida,  32114,  United States; Recruiting
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
      MD Anderson Cancer Center Orlando, Orlando,  Florida,  32806-2134,  United States; Recruiting
      Morton Plant Hospital, Clearwater,  Florida,  33756,  United States; Recruiting
      Oncology Hematology Consultants, Sarasota,  Florida,  34231,  United States; Recruiting
      Shands Cancer Center at the University of Florida Health Science Center, Gainesville,  Florida,  32610-0277,  United States; Recruiting
      University of Miami Sylvester Comprehensive Cancer Center, Miami,  Florida,  33136,  United States; Recruiting
      Veterans Affairs Medical Center - Tampa (Haley), Tampa,  Florida,  33612,  United States; Recruiting
Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States; Recruiting
      Dwight David Eisenhower Army Medical Center, Fort Gordon,  Georgia,  30905-5650,  United States; Recruiting
      MBCCOP-Medical College of Georgia Cancer Center, Augusta,  Georgia,  30912-4000,  United States; Recruiting
      Phoebe Cancer Center at Phoebe Putney Memorial Hospital, Albany,  Georgia,  31701,  United States; Recruiting
      Winship Cancer Institute of Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Idaho
      North Idaho Cancer Center, Coeur D Alene,  Idaho,  83814,  United States; Recruiting
Illinois
      Alexian Brothers Medical Center, Elk Grove Village,  Illinois,  60007,  United States; Recruiting
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States; Recruiting
      MBCCOP-Cook County Hospital, Chicago,  Illinois,  60612,  United States; Recruiting
      Rush Cancer Institute at Rush University Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
      Saint Anthony Medical Center, Rockford,  Illinois,  61108,  United States; Recruiting
      Veterans Affairs Medical Center - Hines (Edward Hines, Junior Hospital), Hines,  Illinois,  60141,  United States; Recruiting
      West Suburban Hospital Medical Center, Oak Park,  Illinois,  60302,  United States; Recruiting
Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
      Community Hospital, Munster,  Indiana,  46321,  United States; Recruiting
      Methodist Cancer Center at Methodist Hospital, Indianapolis,  Indiana,  46206-1367,  United States; Recruiting
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States; Recruiting
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States; Recruiting
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States; Recruiting
Kentucky
      Consultants in Blood Disorders and Cancer, Louisville,  Kentucky,  40207,  United States; Recruiting
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0093,  United States; Recruiting
      Norton Healthcare Cancer Center, Louisville,  Kentucky,  40202-5070,  United States; Recruiting
      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40502-2236,  United States; Recruiting
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States; Recruiting
      Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States; Recruiting
      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States; Recruiting
      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States; Recruiting
      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71101-4295,  United States; Recruiting
Maine
      Eastern Maine Medical Center, Bangor,  Maine,  04401,  United States; Recruiting
Maryland
      Franklin Square Hospital Center, Baltimore,  Maryland,  21237,  United States; Recruiting
      National Naval Medical Center, Bethesda,  Maryland,  20889-5000,  United States; Recruiting
Massachusetts
      Baystate Regional Cancer Program at Baystate Medical Center, Springfield,  Massachusetts,  01199,  United States; Recruiting
      Berkshire Medical Center, Pittsfield,  Massachusetts,  01201,  United States; Recruiting
      Cancer Research Center at Boston Medical Center, Boston,  Massachusetts,  02118,  United States; Recruiting
      Lahey Clinic Medical Center - Burlington, Burlington,  Massachusetts,  01805,  United States; Recruiting
      University of Massachusetts Memorial Medical Center - University Campus, Worcester,  Massachusetts,  01655,  United States; Recruiting
Michigan
      CCOP - Beaumont, Royal Oak,  Michigan,  48073-6769,  United States; Recruiting
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
      Josephine Ford Cancer Center at Henry Ford Hospital, Detroit,  Michigan,  48202,  United States; Recruiting
      Michigan State University, East Lansing,  Michigan,  48824,  United States; Recruiting
      Providence Cancer Institute at Providence Hospital, Southfield,  Michigan,  48075-9975,  United States; Recruiting
      University of Michigan Cancer Center CCOP Research Base, Ann Arbor,  Michigan,  48109-0725,  United States; Recruiting
      Veterans Affairs Medical Center - Ann Arbor, Ann Arbor,  Michigan,  48105,  United States; Recruiting
      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States; Recruiting
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States; Recruiting
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
      Coborn Cancer Center, Saint Cloud,  Minnesota,  56303,  United States; Recruiting
      Hennepin County Medical Center - Minneapolis, Minneapolis,  Minnesota,  55415,  United States; Recruiting
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
      St. Louis University Hospital Cancer Center, Minneapolis,  Minnesota,  55415,  United States; Recruiting
Mississippi
      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States; Recruiting
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States; Recruiting
      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
      Missouri Baptist Cancer Center, Saint Louis,  Missouri,  63131,  United States; Recruiting
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
      Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha,  Nebraska,  68114,  United States; Recruiting
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
New Jersey
      Cancer Institute of New Jersey at Robert Wood Johnson University Hospital, New Brunswick,  New Jersey,  08903,  United States; Recruiting
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States; Recruiting
      Newark Beth Israel Medical Center, Newark,  New Jersey,  07112,  United States; Recruiting
New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States; Recruiting
      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States; Recruiting
New York
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse,  New York,  13217,  United States; Recruiting
      Charles R. Wood Cancer Center at Glens Falls Hospital, Glens Falls,  New York,  12801,  United States; Recruiting
      Lincoln Medical and Mental Health Center, Bronx,  New York,  10451,  United States; Recruiting
      MBCCOP-Our Lady of Mercy Cancer Center, Bronx,  New York,  10466,  United States; Recruiting
      New York Oncology Hematology, P.C. at Albany Regional Cancer Center, Albany,  New York,  12208,  United States; Recruiting
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States; Recruiting
      Staten Island University Hospital, Staten Island,  New York,  10305,  United States; Recruiting
North Carolina
      Alamance Cancer Center, Burlington,  North Carolina,  27216,  United States; Recruiting
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States; Recruiting
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
      Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina, Greenville,  North Carolina,  27835-6028,  United States; Recruiting
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States; Recruiting
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States; Recruiting
      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States; Recruiting
Ohio
      Akron City Hospital at Summa Health System, Akron,  Ohio,  44312,  United States; Recruiting
      Arthur G. James Cancer Hospital at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
      Aultman Hospital Cancer Center at Aultman Health Foundation, Canton,  Ohio,  44710,  United States; Recruiting
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
      CCOP - Dayton, Kettering,  Ohio,  45429,  United States; Recruiting
      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States; Recruiting
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0501,  United States; Recruiting
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States; Recruiting
      Jewish Hospital of Cincinnati, Incorporated, Cincinnati,  Ohio,  45236,  United States; Recruiting
      South Pointe Hospital, Cleveland,  Ohio,  44122,  United States; Recruiting
      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States; Recruiting
      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428-1002,  United States; Recruiting
Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States; Recruiting
Pennsylvania
      Albert Einstein Cancer Center, Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15212-4772,  United States; Recruiting
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States; Recruiting
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15236,  United States; Recruiting
      John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown,  Pennsylvania,  18103,  United States; Recruiting
      Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States; Recruiting
      Mercy Hospital Cancer Center - Scranton, Scranton,  Pennsylvania,  18501,  United States; Recruiting
      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States; Recruiting
      Wellspan Health - York Cancer Center, York,  Pennsylvania,  17403,  United States; Recruiting
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
      Veterans Affairs Medical Center - Charleston, Charleston,  South Carolina,  29401-5799,  United States; Recruiting
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States; Recruiting
Tennessee
      Saint Thomas Hospital, Nashville,  Tennessee,  37205,  United States; Recruiting
      Thompson Cancer Survival Center, Knoxville,  Tennessee,  37916,  United States; Recruiting
      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States; Recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
      CCOP - Virginia Mason Research Center, San Antonio,  Texas,  78284-7811,  United States; Recruiting
      Joe Arrington Cancer Research and Treatment Center, Lubbock,  Texas,  79410-1894,  United States; Recruiting
      Presbyterian Hospital of Dallas, Dallas,  Texas,  75231,  United States; Recruiting
      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390,  United States; Recruiting
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States; Recruiting
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States; Recruiting
      Veterans Affairs Medical Center - Amarillo, Amarillo,  Texas,  79106,  United States; Recruiting
      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78229,  United States; Recruiting
      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States; Recruiting
Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States; Recruiting
      Utah Valley Regional Medical Center - Provo, Provo,  Utah,  84604,  United States; Recruiting
      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States; Recruiting
Vermont
      Green Mountain Oncology Group, Bennington,  Vermont,  05201,  United States; Recruiting
      Vermont Cancer Center at University of Vermont, Burlington,  Vermont,  05405-0075,  United States; Recruiting
Virginia
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States; Recruiting
      Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk,  Virginia,  23507,  United States; Recruiting
      Virginia Oncology Associates - Newport News, Newport News,  Virginia,  23606,  United States; Recruiting
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States; Recruiting
      Puget Sound Oncology Consortium, Seattle,  Washington,  98109,  United States; Recruiting
      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States; Recruiting
West Virginia
      Camden-Clark Memorial Hospital, Parkersburg,  West Virginia,  26102,  United States; Recruiting
      David Lee Cancer Center at Charleston Area Medical Center, Charleston,  West Virginia,  25304-1297,  United States; Recruiting
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
      St. Luke's Medical Center, Milwaukee,  Wisconsin,  53215,  United States; Recruiting
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting
Canada, Ontario
      Sunnybrook and Women's College Health Sciences Centre, North York,  Ontario,  M4N 3M5,  Canada; Recruiting
Canada, Quebec
      Hopital du Saint-Sacrement, Quebec, Quebec City,  Quebec,  G1S 4L8,  Canada; Recruiting
      Jewish General Hospital - Montreal, Montreal,  Quebec,  Canada; Recruiting
      Royal Victoria Hospital - Montreal, Montreal,  Quebec,  H3A 1A1,  Canada; Recruiting
      St. Mary's Hospital Center, Montreal,  Quebec,  H3T 1M5,  Canada; Recruiting
Canada, Saskatchewan
      Allan Blair Cancer Centre at Pasqua Hospital, Regina,  Saskatchewan,  S4T 7T1,  Canada; Recruiting
Puerto Rico
      MBCCOP - San Juan, San Juan,  00927-5800,  Puerto Rico; Recruiting

Study chairs or principal investigators

Richard G. Margolese, MD,  Study Chair,  Jewish General Hospital   
Betty A. Mincey, MD,  Study Chair,  Mayo Clinic - Jacksonville   
Kathy S. Albain, MD,  Study Chair,  Loyola University   
Pat W. Whitworth, MD,  Study Chair,  Saint Thomas Hospital   

Study ID Numbers:  CDR0000269539; NSABP-B-35; CTSU; SWOG-NSABP-B-35; NCCTG-NSABP-B-35; ACOSOG-NSABP-B-35
Record last reviewed:  September 2004
Record first received:  February 5, 2003
ClinicalTrials.gov Identifier:  NCT00053898
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-05