RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin , cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells.

PURPOSE: This randomized phase III trial is studying three different combination chemotherapy regimens and comparing how well they work in treating women who have undergone surgery for node-positive breast cancer.

Condition	Treatment or Intervention	Phase
stage II breast cancer stage IIIA breast cancer stage IIIC breast cancer	Drug: cyclophosphamide  Drug: docetaxel  Drug: doxorubicin  Drug: gemcitabine  Drug: paclitaxel  Procedure: adjuvant therapy  Procedure: chemotherapy  Procedure: radiation therapy	Phase III

Further Study Details: 

OBJECTIVES: Primary

• Compare disease-free survival in women with node-positive breast cancer treated with 3 different adjuvant chemotherapy regimens comprising dose-dense doxorubicin, cyclophosphamide, paclitaxel, and gemcitabine vs docetaxel, doxorubicin, and cyclophosphamide vs dose-dense doxorubicin, cyclophosphamide, and paclitaxel.

Secondary

• Compare overall survival, recurrence-free interval, and distant recurrence-free interval, in patients treated with these regimens.
• Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive lymph nodes (1-3 vs 4-9 vs ≥ 10), hormone receptor status (estrogen receptor [ER]- and progesterone receptor [PgR]- negative vs ER- and/or PgR-positive), type of prior surgery and planned radiotherapy (lumpectomy and local radiotherapy [RT] without regional RT vs lumpectomy and local RT with regional RT vs mastectomy without RT vs mastectomy with local and/or regional RT). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 30 minutes, and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses.
• Arm II: Patients receive AC chemotherapy comprising doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 14 days for 4 courses. Beginning 14 days after the last dose of AC, patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses.
• Arm III: Patients AC chemotherapy as in arm II. Beginning 14 days after the last dose of AC, patients receive paclitaxel as in arm II and gemcitabine IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 4 courses. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Beginning 3-12 weeks after the last dose of chemotherapy, patients with ER-positive and/or PgR-positive tumors receive hormonal therapy comprising tamoxifen and/or an aromatase inhibitor .

Beginning no sooner than 3 weeks after the last course of chemotherapy, patients treated with lumpectomy undergo whole-breast radiotherapy. Patients treated with mastectomy may undergo chest wall and/or regional nodal radiotherapy.

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

PROJECTED ACCRUAL: A total of 4,800 patients will be accrued for this study within 4 years.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer, meeting all of the following staging criteria:
• Primary tumor T1-3 by clinical and pathological evaluation
• Ipsilateral lymph nodes cN0, cN1, or cN2a by clinical evaluation
• Ipsilateral lymph nodes pN1 (pN1mi, pN1a, pN1b, or pN1c), pN2a, pN3a, or pN3b* by pathologic evaluation
• Must have completed 1 of the following procedures for evaluation of pathological nodal status:
• Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes
• Sentinel lymphadenectomy alone allowed provided 1 of the following criteria is met:
• Pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1b
• Randomized to arm not undergoing axillary dissection on protocol
• No additional non-sentinel lymph nodes are removed
• Axillary lymphadenectomy without sentinel lymph node isolation procedure NOTE: *Only if due to microscopic involvement of internal mammary node detected by sentinel lymph node dissection AND has > 3 positive axillary lymph nodes
• Must have undergone prior lumpectomy or total mastectomy
• Lumpectomy patients:
• Surgical margins must be histologically free of invasive tumor AND ductal carcinoma in situ (DCIS) (lobular carcinoma in situ [LCIS] allowed)
• Additional operative procedures may be performed to obtain clear margins* even if axillary evaluation has been completed
• No diffuse tumors* by mammography
• No other clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast unless proven to be histologically benign OR if malignant, surgically removed with clear margins
• Planned whole breast irradiation required NOTE: *Patients with persistent positive margins or diffuse tumors must undergo total mastectomy to be eligible for this study
• No more than 84 days since last surgery for breast cancer staging or treatment
• No clinical or radiologic evidence of metastatic disease
• No contralateral breast cancer (invasive breast cancer or DCIS)
• No mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy evidence that the mass is not malignant
• No suspicious nodes in the contralateral axilla or suspicious supraclavicular nodes unless there is biopsy evidence of no tumor involvement
• No prior breast cancer, including DCIS
• LCIS allowed
• Hormone receptor status:
• Estrogen receptor (ER) status known
• Progesterone receptor status known only if ER-negative

PATIENT CHARACTERISTICS: Age

• Not specified

Sex

• Female

Menopausal status

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• At least 10 years

Hematopoietic

• Absolute granulocyte count ≥ 1,200/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ upper limit of normal (ULN)* (1.5 times ULN if due to Gilbert's disease or similar syndrome)
• Alkaline phosphatase < 2.5 times ULN*
• AST ≤ 1.5 times ULN*
• No hepatic disease that would preclude study participation NOTE: *Bilirubin, AST, OR alkaline phosphatase > ULN allowed provided no metastatic liver disease is present on imaging

Renal

• Creatinine ≤ ULN
• No renal disease that would preclude study participation

Cardiovascular

• LVEF ≥ lower limit of normal by echocardiogram or MUGA
• No cardiac disease that would preclude the use of anthracyclines, including any of the following:
• History of myocardial infarction documented by elevated cardiac enzymes or regional wall abnormalities
• Angina pectoris requiring anti-anginal medication
• Documented history of congestive heart failure
• Serious cardiac arrhythmia requiring medication
• Severe conduction abnormality
• Valvular disease with documented cardiac function compromise
• Uncontrolled hypertension, defined as blood pressure > 160/100 mm Hg with antihypertensive therapy
• No other cardiovascular disease that would preclude study participation

Other

• Not pregnant or nursing
• Fertile patients must use effective non-hormonal contraception
• No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or melanoma in situ
• Considered to be low-risk for recurrence
• No condition that would preclude corticosteroid administration
• No sensory or motor neuropathy ≥ grade 2
• No other nonmalignant systemic disease that would preclude study participation
• No psychiatric or addictive disorder or other condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

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

Endocrine therapy

• See Disease Characteristics
• Prior hormonal therapy for breast cancer allowed provided the duration of therapy was ≤ 28 days
• No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormone replacement therapy, or Femring®)
• Concurrent Vagifem® or Estring® for the management of vaginal or urinary symptoms allowed
• No concurrent raloxifene, tamoxifen, or other selective estrogen-receptor modulators (SERMs) for osteoporosis or breast cancer prevention

Radiotherapy

• See Disease Characteristics
• No prior radiotherapy for breast cancer
• No concurrent partial breast irradiation (lumpectomy patients)
• Concurrent irradiation of regional lymph nodes allowed

Surgery

• See Disease Characteristics

Other

• Concurrent calcium supplements, cholecalciferol (vitamin D), calcitonin (e.g., Miacalcin®), or bisphosphonates (e.g., Actonel® or Fosamax®) for the management of osteoporosis allowed
• No other concurrent investigational agents for the treatment of breast cancer

Alabama
      Mobile Infirmary Medical Center, Mobile,  Alabama,  36652-2144,  United States; Recruiting
California
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States; Recruiting
      Comprehensive Cancer Center at Desert Regional Medical Center, Palm Springs,  California,  92262,  United States; Recruiting
      Glendale Memorial Hospital and Health Center, Glendale,  California,  91204,  United States; Recruiting
      Kaiser Foundation Hospital - West Los Angeles, Los Angeles,  California,  90034,  United States; Recruiting
      Kaiser Permanente - Fremont, Fremont,  California,  94538,  United States; Recruiting
      Kaiser Permanente Medical Center - Hayward, Hayward,  California,  94545,  United States; Recruiting
      Kaiser Permanente Medical Center - Redwood City, Redwood City,  California,  94063,  United States; Recruiting
      Kaiser Permanente Medical Center - Richmond, Richmond,  California,  94801,  United States; Recruiting
      Kaiser Permanente Medical Center - Roseville, Roseville,  California,  95661,  United States; Recruiting
      Kaiser Permanente Medical Center - Sacramento, Sacramento,  California,  95825,  United States; Recruiting
      Kaiser Permanente Medical Center - San Francisco Geary Campus, San Francisco,  California,  94115,  United States; Recruiting
      Kaiser Permanente Medical Center - Santa Clara, Santa Clara,  California,  95051-5386,  United States; Recruiting
      Kaiser Permanente Medical Center - Santa Rosa, Santa Rosa,  California,  95403,  United States; Recruiting
      Kaiser Permanente Medical Center - Santa Teresa, Santa Teresa,  California,  95119,  United States; Recruiting
      Kaiser Permanente Medical Center - South San Francisco, South San Francisco,  California,  94080,  United States; Recruiting
      Kaiser Permanente Medical Center - Vallejo, Vallejo,  California,  94589,  United States; Recruiting
      Kaiser Permanente Medical Center - Walnut Creek, Walnut Creek,  California,  94596,  United States; Recruiting
      Kaiser Permanente Medical Facility - Stockton, Stockton,  California,  95210,  United States; Recruiting
      Kaiser Permanente Medical Group, Panorama City,  California,  91402,  United States; Recruiting
      Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States; Recruiting
      North Bay Cancer Center, Fairfield,  California,  94533,  United States; Recruiting
      Santa Rosa Memorial Hospital, Santa Rosa,  California,  95405,  United States; Recruiting
      South Sacramento Kaiser-Permanente Medical Center, Sacramento,  California,  95823,  United States; Recruiting
      Sutter Cancer Center, Sacramento,  California,  95816,  United States; Recruiting
Colorado
      Front Range Cancer Specialists, Fort Collins,  Colorado,  80524-4038,  United States; Recruiting
      Poudre Valley Hospital, Fort Collins,  Colorado,  80524,  United States; Recruiting
Delaware
      Beebe Medical Center, Lewes,  Delaware,  19958,  United States; Recruiting
      Helen F. Graham Cancer Center, Newark,  Delaware,  19713,  United States; Recruiting
      Nanticoke Memorial Hospital, Seaford,  Delaware,  19973,  United States; Recruiting
      St. Francis Hospital, Wilmington,  Delaware,  19805,  United States; Recruiting
District of Columbia
      Sibley Memorial Hospital, Washington,  District of Columbia,  20016,  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
      Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter,  Florida,  33458,  United States; Recruiting
      Florida Oncology Associates, Orange Park,  Florida,  32073,  United States; Recruiting
      Halifax Medical Center, Daytona Beach,  Florida,  32114,  United States; Recruiting
      Joe DiMaggio Children's Hospital at Memorial, Hollywood,  Florida,  33021,  United States; Recruiting
      Martin Memorial Cancer Center, Stuart,  Florida,  34995-9010,  United States; Recruiting
      Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale,  Florida,  33308,  United States; Recruiting
Georgia
      Phoebe Cancer Center at Phoebe Putney Memorial Hospital, Albany,  Georgia,  31701,  United States; Recruiting
Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
      Kapiolani Medical Center at Pali Momi, Aiea,  Hawaii,  96701,  United States; Recruiting
      Kapiolani Medical Center for Women and Children, Honolulu,  Hawaii,  96826,  United States; Recruiting
      OnCare Hawaii, Incorporated - Kuakini, Honolulu,  Hawaii,  96817,  United States; Recruiting
      OnCare Hawaii, Incorporated - Lusitana, Honolulu,  Hawaii,  96813,  United States; Recruiting
      Queen's Cancer Institute at Queen's Medical Center, Honolulu,  Hawaii,  96813,  United States; Recruiting
      St. Francis Medical Center, Honolulu,  Hawaii,  96817,  United States; Recruiting
      Straub Clinic and Hospital, Incorporated, Honolulu,  Hawaii,  96813,  United States; Recruiting
Idaho
      North Idaho Cancer Center, Coeur D Alene,  Idaho,  83814,  United States; Recruiting
Illinois
      Carle Clinic Association, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      Joliet Oncology Hematology Associates, Limited - West, Joliet,  Illinois,  60435,  United States; Recruiting
      Regional Cancer Center at Memorial Medical Center, Springfield,  Illinois,  62781,  United States; Recruiting
      Rush-Copley Cancer Care Center, Aurora,  Illinois,  60504-4206,  United States; Recruiting
      Saint Anthony's Hospital at Saint Anthony's Health Center, Alton,  Illinois,  62002,  United States; Recruiting
      Swedish-American Regional Cancer Center, Rockford,  Illinois,  61104-2315,  United States; Recruiting
Indiana
      Saint Anthony Memorial Health Centers, Michigan City,  Indiana,  46360-4358,  United States; Recruiting
      St. Francis Hospital and Health Centers, Beech Grove,  Indiana,  46107,  United States; Recruiting
Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
      Covenant Medical Center, Waterloo,  Iowa,  50702,  United States; Recruiting
      Des Moines General Hospital, Des Moines,  Iowa,  50309,  United States; Recruiting
      John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines,  Iowa,  50316-2301,  United States; Recruiting
      John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines,  Iowa,  50309,  United States; Recruiting
      McFarland Clinic, P.C., Ames,  Iowa,  50010,  United States; Recruiting
      Medical Oncology and Hematology Associates - West Des Moines, West Des Moines,  Iowa,  50266,  United States; Recruiting
      Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines,  Iowa,  50309,  United States; Recruiting
      Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines,  Iowa,  50314,  United States; Recruiting
      Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines,  Iowa,  50314,  United States; Recruiting
Kansas
      Associates in Womens Health, Wichita,  Kansas,  67203,  United States; Recruiting
      Cancer Center of Kansas - Chanute, Chanute,  Kansas,  66720,  United States; Recruiting
      Cancer Center of Kansas - Dodge City, Dodge City,  Kansas,  67801,  United States; Recruiting
      Cancer Center of Kansas - Kingman, Kingman,  Kansas,  67068,  United States; Recruiting
      Cancer Center of Kansas - Newton, Newton,  Kansas,  67114,  United States; Recruiting
      Cancer Center of Kansas - Salina, Salina,  Kansas,  67402,  United States; Recruiting
      Cancer Center of Kansas - Wellington, Wellington,  Kansas,  67152,  United States; Recruiting
      Cancer Center of Kansas - Winfield, Winfield,  Kansas,  67156,  United States; Recruiting
      Cancer Center of Kansas, P.A. - Wichita, Wichita,  Kansas,  67214-3728,  United States; Recruiting
      Cancer Center of Kansas, P.A. - El Dorado, El Dorado,  Kansas,  67042,  United States; Recruiting
      Cancer Center of Kansas, P.A. - Parsons, Parsons,  Kansas,  67357,  United States; Recruiting
      Cancer Center of Kansas, P.A., Wichita,  Kansas,  67208,  United States; Recruiting
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
      Pratt Cancer Center of Kansas, Pratt,  Kansas,  67124,  United States; Recruiting
      Southwest Medical Center, Liberal,  Kansas,  67901,  United States; Recruiting
      Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita,  Kansas,  67214,  United States; Recruiting
Kentucky
      Cancer Resource Center at King's Daughters Medical Center, Ashland,  Kentucky,  41101-0151,  United States; Recruiting
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States; Recruiting
      Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
      Ochsner Clinic of Baton Rouge, Baton Rouge,  Louisiana,  70809,  United States; Recruiting
      Terrebonne General Medical Center, Houma,  Louisiana,  70360,  United States; Recruiting
      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112-2699,  United States; Recruiting
Maine
      CancerCare of Maine at Eastern Maine Medial Center, Bangor,  Maine,  04401,  United States; Recruiting
Maryland
      Cancer Center at Greater Baltimore Medical Center, Baltimore,  Maryland,  21204,  United States; Recruiting
      Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center, Baltimore,  Maryland,  21237,  United States; Recruiting
      St. Agnes Cancer Center, Baltimore,  Maryland,  21229,  United States; Recruiting
      St. Mary's Hospital, Leonardtown,  Maryland,  20650,  United States; Recruiting
      Suburban Hospital, Bethesda,  Maryland,  20814,  United States; Recruiting
      Union Hospital Cancer Center at Union Hospital, Elkton,  Maryland,  21921,  United States; Recruiting
Massachusetts
      Berkshire Medical Center, Pittsfield,  Massachusetts,  01201,  United States; Recruiting
      Hudner Oncology Center at Saint Anne's Hospital, Fall River,  Massachusetts,  02721,  United States; Recruiting
      Lahey Clinic Medical Center - Burlington, Burlington,  Massachusetts,  01805,  United States; Recruiting
Minnesota
      Merit Care Clinic - Bemidji, Bemidji,  Minnesota,  56601,  United States; Recruiting
Mississippi
      Hattiesburg Clinic, P.A., Hattiesburg,  Mississippi,  39401,  United States; Recruiting
      Hematology & Oncology Clinic, Hattiesburg,  Mississippi,  39402,  United States; Recruiting
Missouri
      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
      David C. Pratt Cancer Center at St. John's Mercy, Saint Louis,  Missouri,  63141,  United States; Recruiting
      Freeman Cancer Institute at Freeman Health System, Joplin,  Missouri,  64804,  United States; Recruiting
      Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Cape Girardeau,  Missouri,  63701,  United States; Recruiting
      St. Francis Medical Center, Cape Girardeau,  Missouri,  63701,  United States; Recruiting
      St. John's Regional Health Center, Springfield,  Missouri,  65804-2263,  United States; Recruiting
      St. John's Regional Medical Center, Joplin,  Missouri,  64804,  United States; Recruiting
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States; Recruiting
Nebraska
      Bryan LGH Medical Center - East, Lincoln,  Nebraska,  68506,  United States; Recruiting
      Bryan LGH Medical Center West, Lincoln,  Nebraska,  68502-3780,  United States; Recruiting
      Cancer Resource Center - Lincoln, Lincoln,  Nebraska,  68510-4844,  United States; Recruiting
      St. Elizabeth Regional Medical Center, Lincoln,  Nebraska,  68510,  United States; Recruiting
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
      University Medical Center of Southern Nevada, Las Vegas,  Nevada,  89102-2386,  United States; Recruiting
New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Voorhees,  New Jersey,  08043,  United States; Recruiting
      Newark Beth Israel Medical Center, Newark,  New Jersey,  07112,  United States; Recruiting
      South Jersey Hospital System - Elmer, Elmer,  New Jersey,  08318,  United States; Recruiting
      St. Barnabas Medical Center, Livingston,  New Jersey,  07039,  United States; Recruiting
New York
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse,  New York,  13057,  United States; Recruiting
      Charles R. Wood Cancer Center at Glens Falls Hospital, Glens Falls,  New York,  12801,  United States; Recruiting
      St. Joseph's Hospital Health Center - Syracuse, Syracuse,  New York,  13203,  United States; Recruiting
North Carolina
      Alamance Cancer Center, Burlington,  North Carolina,  27216,  United States; Recruiting
      Hope A Women's Cancer Center, Asheville,  North Carolina,  28816,  United States; Recruiting
      Pardee Memorial Hospital, Hendersonville,  North Carolina,  28791,  United States; Recruiting
North Dakota
      Dakota Cancer Institute at Innovis Health - Dakota Clinic, Fargo,  North Dakota,  58103-4994,  United States; Recruiting
      MeritCare Medical Group, Fargo,  North Dakota,  58103-2067,  United States; Recruiting
      Meritcare Roger Maris Cancer Center, Fargo,  North Dakota,  58122,  United States; Recruiting
Ohio
      Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark,  Ohio,  43055-2899,  United States; Recruiting
      Adena Regional Medical Center, Chillicothe,  Ohio,  45601,  United States; Recruiting
      Akron General's McDowell Cancer Center, Akron,  Ohio,  44302,  United States; Recruiting
      Cancer Center at Christ Hospital, Cincinnati,  Ohio,  45219,  United States; Recruiting
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
      Charles F. Kettering Memorial Hospital, Kettering,  Ohio,  45429,  United States; Recruiting
      Community Hospital of Springfield and Clark County, Springfield,  Ohio,  45505,  United States; Recruiting
      Doctors Hospital at Ohio Health, Columbus,  Ohio,  43228,  United States; Recruiting
      Euclid Hospital, Euclid,  Ohio,  44119,  United States; Recruiting
      Fairfield Medical Center, Lancaster,  Ohio,  43130,  United States; Recruiting
      Good Samaritan Hospital, Dayton,  Ohio,  45406-1891,  United States; Recruiting
      Grady Memorial Hospital, Delaware,  Ohio,  43015,  United States; Recruiting
      Grandview Hospital, Dayton,  Ohio,  45405,  United States; Recruiting
      Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights,  Ohio,  44124,  United States; Recruiting
      Huron Hospital Cancer Care Center, East Cleveland,  Ohio,  44112-9942,  United States; Recruiting
      Middletown Regional Hospital, Middletown,  Ohio,  45044-4898,  United States; Recruiting
      Mount Carmel West Hospital, Columbus,  Ohio,  43222,  United States; Recruiting
      Riverside Methodist Hospital Cancer Care, Columbus,  Ohio,  43214-3998,  United States; Recruiting
      Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia,  Ohio,  45385,  United States; Recruiting
      Samaritan North Cancer Care Center, Dayton,  Ohio,  45415,  United States; Recruiting
      South Pointe Hospital Cancer Care Center, Warrensville Heights,  Ohio,  44122,  United States; Recruiting
      Strecker Cancer Center at Marietta Memorial Hospital, Marietta,  Ohio,  45750-1635,  United States; Recruiting
      University Hospitals Ireland Cancer Center at Mercy Medical Center, Canton,  Ohio,  44708,  United States; Recruiting
      UVMC Cancer Care Center at Upper Valley Medical Center, Troy,  Ohio,  45373-1300,  United States; Recruiting
      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428-1002,  United States; Recruiting
Oregon
      Bend Memorial Clinic, Bend,  Oregon,  97701-6099,  United States; Recruiting
      St. Charles Medical Center, Bend,  Oregon,  97701,  United States; Recruiting
Pennsylvania
      Albert Einstein Cancer Center, Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
      Bryn Mawr Hospital, Bryn Mawr,  Pennsylvania,  19010,  United States; Recruiting
      Cancer Center at Paoli Memorial Hospital, Paoli,  Pennsylvania,  19301-1792,  United States; Recruiting
      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States; Recruiting
      John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown,  Pennsylvania,  18105-7017,  United States; Recruiting
      Lankenau Cancer Center at Lankenau Hospital, Wynnewood,  Pennsylvania,  19096,  United States; Recruiting
      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States; Recruiting
      Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh,  Pennsylvania,  15224,  United States; Recruiting
Texas
      Baylor University Medical Center, Dallas,  Texas,  75246,  United States; Recruiting
Vermont
      Community Cancer Center at Rutland Regional Medical Center, Rutland,  Vermont,  05701,  United States; Recruiting
Virginia
      Lynchburg Hematology-Oncology Clinic, Lynchburg,  Virginia,  24501,  United States; Recruiting
      Martha Jefferson Hospital, Charlottesville,  Virginia,  22902,  United States; Recruiting
      Virginia Cancer Institute - West End, Richmond,  Virginia,  23230,  United States; Recruiting
Washington
      Allenmore Hospital, Tacoma,  Washington,  98411-0414,  United States; Recruiting
      Auburn Regional Center for Cancer Care at Auburn Regional Medical Center, Auburn,  Washington,  98001-4908,  United States; Recruiting
      Capital Medical Center, Olympia,  Washington,  98502,  United States; Recruiting
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States; Recruiting
      Good Samaritan Hospital, Puyallup,  Washington,  98371,  United States; Recruiting
      Providence Cancer Center at Holy Family Hospital, Spokane,  Washington,  99208,  United States; Recruiting
      Providence Cancer Center at Sacred Heart Medical Center, Spokane,  Washington,  99204,  United States; Recruiting
      Providence St. Peter Hospital Regional Cancer Center, Olympia,  Washington,  98506,  United States; Recruiting
      St. Clare Hospital, Lakewood,  Washington,  98499-0998,  United States; Recruiting
      St. Francis Hospital, Federal Way,  Washington,  98003,  United States; Recruiting
      St. Joseph Medical Center at Franciscan Health System, Tacoma,  Washington,  98405-3004,  United States; Recruiting
West Virginia
      Camden-Clark Memorial Hospital, Parkersburg,  West Virginia,  26102,  United States; Recruiting
Wisconsin
      Dean Medical Center, Madison,  Wisconsin,  53715,  United States; Recruiting
      Marshfield Clinic - Marshfield Center, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Canada, Ontario
      Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital, Mississauga,  Ontario,  L5M 2N1,  Canada; Recruiting
Puerto Rico
      Andres Grillasca Hospital, Ponce,  00733-1324,  Puerto Rico; Recruiting
      Hato Rey Hematology/Oncology Group, San Juan,  00917,  Puerto Rico; Recruiting
      San Juan City Hospital, San Juan,  00936-7344,  Puerto Rico; Recruiting

Study chairs or principal investigators

Sandra M. Swain, MD,  Study Chair,  National Cancer Institute (NCI)   

Study ID Numbers:  CDR0000390286; NSABP-B-38; NCT00093795
Record last reviewed:  March 2005
Last Updated:  April 4, 2005
Record first received:  October 6, 2004
ClinicalTrials.gov Identifier:  NCT00093795
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08