RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus trastuzumab is more effective than combination chemotherapy alone for treating breast cancer.

PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy together with trastuzumab works compared to giving combination chemotherapy alone in treating women with node-positive stage II or stage IIIA breast cancer that overexpresses HER2.

Condition	Treatment or Intervention	Phase
stage II breast cancer stage IIIA breast cancer	Drug: anastrozole  Drug: cyclophosphamide  Drug: doxorubicin  Drug: paclitaxel  Drug: tamoxifen  Drug: trastuzumab  Procedure: antibody therapy  Procedure: antiestrogen therapy  Procedure: aromatase inhibition  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: monoclonal antibody therapy  Procedure: radiation therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare the cardiotoxicity of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin) in women with operable, node-positive breast cancer that overexpresses HER2.
• Compare the effect of these regimens on disease-free and overall survival of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (1-3 vs 4-9 vs 10 or more), administration of hormonal therapy (tamoxifen vs anastrozole vs neither), surgery/radiotherapy (lumpectomy plus breast irradiation vs lumpectomy plus breast irradiation plus regional irradiation vs mastectomy without radiotherapy vs mastectomy with radiotherapy), paclitaxel schedule (every 3 weeks vs weekly), and participating center. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. Approximately 3 weeks after the last course, patients receive paclitaxel IV over 3 hours every 21 days for 4 courses OR paclitaxel IV over 1 hour once weekly for 12 weeks (12 doses).
• Arm II: Patients receive chemotherapy as in arm I and trastuzumab (Herceptin) IV over 90 minutes on day 1 of the first course of paclitaxel. Trastuzumab is then administered IV over 30 minutes weekly for 51 weeks, beginning on day 8. All patients with estrogen or progesterone receptor-positive tumors receive oral tamoxifen* once daily for 5 years, beginning within 3-12 weeks after the last dose of chemotherapy. Patients who have received prior tamoxifen for prevention may be treated with additional tamoxifen at the discretion of the principal investigator (PI).

NOTE: *At the discretion of the PI, oral anastrozole (administered on the same schedule as tamoxifen) may be substituted for tamoxifen for postmenopausal patients.

All patients previously treated with lumpectomy undergo breast irradiation beginning after completion of chemotherapy and concurrently with trastuzumab (in arm II) administration. Patients previously treated with mastectomy may also receive radiotherapy. Radiotherapy is administered daily for 5-6 weeks.

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

PROJECTED ACCRUAL: A total of 2,700 patients will be accrued for this study within 4.75 years.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven invasive adenocarcinoma of the breast
• Stage IIA, IIB, or IIIA
• Confined to the breast and ipsilateral axilla (cN0-1) on clinical examination
• At least 1 histologically positive axillary node
• No lymph nodes clinically fixed to each other or to other structures (cN2)
• HER2 strongly positive (3+ by immunostain OR gene amplification by fluorescent in situ hybridization)
• Submission of tumor block required
• Must have undergone axillary dissection and either total mastectomy OR lumpectomy
• Sentinel node dissection allowed, if followed by axillary dissection
• No diffuse tumors by mammography in patients treated with lumpectomy
• No more than 84 days since prior surgery for breast cancer (e.g., lumpectomy, mastectomy, axillary dissection, or re-excision of lumpectomy margins)
• No bilateral malignancy, contralateral mass, or mammographic abnormality unless histologically proven as benign
• No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes unless histologically proven not to be involved with tumor
• No primary T4 tumors (for any reason)
• No prior breast cancer, including ductal carcinoma in situ
• Prior lobular carcinoma in situ allowed
• Bone pain allowed provided there is no metastatic disease by x-ray, MRI, or biopsy
• Hormone receptor status:
• Estrogen and progesterone status known

PATIENT CHARACTERISTICS: Age:

• Not specified

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• At least 10 years, excluding diagnosis of breast cancer

Hematopoietic:

• Platelet count at least 100,000/mm^3*
• Absolute neutrophil count at least 1,500/mm^3 (unless determined by the investigator to be normal for ethnic or racial variation) NOTE: *Significant underlying hematologic disorders must be excluded if above upper limit of normal (ULN)

Hepatic:

• Bilirubin no greater than ULN
• SGOT less than 1.5 times ULN
• Alkaline phosphatase less than 2.5 times ULN
• No systemic hepatic disease that would preclude study participation

Renal:

• Creatinine normal
• No systemic renal disease that would preclude study participation

Cardiovascular:

• LVEF at least lower limit of normal by MUGA
• No cardiovascular disease that would preclude study participation
• No angina pectoris requiring treatment
• No cardiomegaly on chest x-ray
• No prior myocardial infarction by clinical diagnosis or by EKG or other test
• No prior congestive heart failure
• No prior cardiomyopathy
• No cardiac arrhythmia requiring medication
• No severe conduction abnormality
• No clinically significant valvular disease
• No poorly controlled hypertension (diastolic greater than 100 mm Hg), unless adequately controlled by medication
• No ventricular hypertrophy on EKG

Other:

• Not pregnant or nursing
• Fertile patients must use effective barrier contraception
• No other prior malignancy within the past 5 years except effectively treated carcinoma in situ of the cervix, melanoma in situ, or basal cell or squamous cell skin cancer
• No psychiatric or addictive disorders that would preclude informed consent
• No sensory or motor neuropathy grade 2 or greater
• No contraindications to corticosteroids

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No prior biologic therapy for this breast cancer

Chemotherapy:

• No prior chemotherapy for this breast cancer
• No prior anthracycline or taxane therapy for any cancer

Endocrine therapy:

• No prior hormonal therapy for this breast cancer
• No concurrent hormonal therapy (e.g., birth control pills or ovarian hormone replacement therapy)
• No concurrent raloxifene or other selective estrogen-receptor modulators

Radiotherapy:

• No prior radiotherapy for this breast cancer
• No concurrent radiotherapy to internal mammary nodes
• No other concurrent radiotherapy except as specified in study

Surgery:

• See Disease Characteristics

Other:

• No other concurrent investigational agents

Alabama
      Comprehensive Cancer Institute, Huntsville,  Alabama,  35801,  United States; Recruiting
Alaska
      Providence Alaska Medical Center, Anchorage,  Alaska,  99519-6604,  United States; Recruiting
Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
California
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States; Recruiting
      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States; Recruiting
      Chao Family Comprehensive Cancer Center at University of California Irvine Medical 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
      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
      Scripps Cancer Center at Scripps Clinic, La Jolla,  California,  92037,  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
Colorado
      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80209-5031,  United States; Recruiting
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80010,  United States; Recruiting
Connecticut
      Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington,  Connecticut,  06360-7106,  United States; Recruiting
      Helen and Harry Gray Cancer Center at Hartford Hospital, Hartford,  Connecticut,  06102-5037,  United States; Recruiting
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States; Recruiting
Florida
      Baptist Cancer Institute - Jacksonville, Jacksonville,  Florida,  32207,  United States; Recruiting
      Cancer Research Network, Inc., Plantation,  Florida,  33324,  United States; Recruiting
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States; Recruiting
      Florida Cancer Specialists, Sarasota,  Florida,  34236,  United States; Recruiting
      Halifax Medical Center, Daytona Beach,  Florida,  32114,  United States; Recruiting
      M.D. Anderson Cancer Center - Orlando, Orlando,  Florida,  32806,  United States; Recruiting
      Morton Plant Hospital, Clearwater,  Florida,  33756,  United States; Recruiting
      University of Miami Sylvester Comprehensive Cancer Center, Miami,  Florida,  33136,  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
Idaho
      North Idaho Cancer Center, Coeur D Alene,  Idaho,  83814,  United States; Recruiting
Illinois
      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
      Creticos Cancer Center at Advocate Illinois Masonic Medical Center, Chicago,  Illinois,  60657,  United States; Recruiting
      John H. Stroger, Jr. Hospital of Cook County, Chicago,  Illinois,  60612-9985,  United States; Recruiting
      Rush Cancer Institute at Rush University Medical Center, Chicago,  Illinois,  60612,  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 - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
      Genesis Regional Cancer Center at Genesis Medical Center, Davenport,  Iowa,  52803,  United States; Recruiting
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  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 Cancer Center at Norton Hospital, Louisville,  Kentucky,  40202-5070,  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
Maine
      CancerCare of Maine at Eastern Maine Medial Center, Bangor,  Maine,  04401,  United States; Recruiting
Maryland
      Harry and Jeanette Weinberg Cancer Institute at 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 D'Amour Center for Cancer Care, 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
      UMASS Memorial Cancer Center - University Campus, Worcester,  Massachusetts,  01655,  United States; Recruiting
Michigan
      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 Health System, Detroit,  Michigan,  48202,  United States; Recruiting
      Michigan State University, East Lansing,  Michigan,  48824,  United States; Recruiting
      Providence Cancer Institute at Providence Hospital - Southfield, Southfield,  Michigan,  48075-9975,  United States; Recruiting
      William Beaumont Hospital - Royal Oak, Royal Oak,  Michigan,  48073,  United States; Recruiting
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States; Recruiting
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
      Hennepin County Medical Center - Minneapolis, Minneapolis,  Minnesota,  55415,  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
      Saint Louis University Cancer Center, Saint Louis,  Missouri,  63110-0250,  United States; Recruiting
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  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 UMDNJ - Robert Wood Johnson Medical School, 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
      University of New Mexico Cancer Research and Treatment Center, Albuquerque,  New Mexico,  87131,  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
      Nalitt Cancer Institute at Staten Island University Hospital, Staten Island,  New York,  10305,  United States; Recruiting
      New York Oncology Hematology, P.C. at Albany Regional Cancer Care, Albany,  New York,  12208,  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 at Pitt County Memorial Hospital, Greenville,  North Carolina,  27858-4354,  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
Ohio
      Akron City Hospital at Summa Health System, Akron,  Ohio,  44309,  United States; Recruiting
      Arthur G. James Cancer Hospital and Solove Research Institute 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
      Cancer Care Center at Northside Medical Center, Youngstown,  Ohio,  44501,  United States; Recruiting
      Cancer Center at Jewish Hospital, Cincinnati,  Ohio,  45236,  United States; Recruiting
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
      CCOP - Dayton, Kettering,  Ohio,  45429,  United States; Recruiting
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0502,  United States; Recruiting
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5065,  United States; Recruiting
      South Pointe Hospital Cancer Care Center, Cleveland,  Ohio,  44122,  United States; Recruiting
Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97213,  United States; Recruiting
Pennsylvania
      Albert Einstein Cancer Center, Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15212-4772,  United States; Recruiting
      Geisinger Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213-3489,  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
      York Cancer Center at Wellspan Health, York,  Pennsylvania,  17315,  United States; Recruiting
Rhode Island
      Kent County Memorial Hospital, Warwick,  Rhode Island,  02886,  United States; Recruiting
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
      Joe Arrington Cancer Research and Treatment Center, Lubbock,  Texas,  79410-1894,  United States; Recruiting
      Medical City Dallas Hospital, Dallas,  Texas,  75230,  United States; Recruiting
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States; Recruiting
Utah
      Utah Valley Regional Medical Center - Provo, Provo,  Utah,  84604,  United States; Recruiting
Vermont
      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
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States; Recruiting
      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States; Recruiting
      Puget Sound Oncology Consortium, Seattle,  Washington,  98109,  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
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
      Oncology Alliance, S.C. - Milwaukee, Milwaukee,  Wisconsin,  53211-2906,  United States; Recruiting
      St. Vincent Hospital, Green Bay,  Wisconsin,  54307-3508,  United States; Recruiting
Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada; Recruiting
Canada, Ontario
      Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital, Mississauga,  Ontario,  L5M 2N1,  Canada; Recruiting
Canada, Quebec
      Centre Hospitalier de l'Universite de Montreal, Montreal,  Quebec,  H2L 4M1,  Canada; Recruiting
      Hopital du Saint-Sacrement, Quebec, Quebec City,  Quebec,  G1S 4L8,  Canada; Recruiting
      Jewish General Hospital - Montreal, Montreal,  Quebec,  H3T 1E2,  Canada; Recruiting
      Montreal General Hospital, Montreal,  Quebec,  H3G 1A4,  Canada; Recruiting
      Royal Victoria Hospital - Montreal, Montreal,  Quebec,  H3A 1A1,  Canada; Recruiting
      St. Mary's Hospital Center, Montreal,  Quebec,  H3T 1M5,  Canada; Recruiting

Study chairs or principal investigators

Edward H. Romond, MD,  Study Chair,  University of Kentucky   

Study ID Numbers:  CDR0000067269; NSABP-B-31; NCT00004067
Record last reviewed:  August 2004
Last Updated:  April 4, 2005
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004067
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08