Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer

Sponsor
NSABP Foundation Inc (Other)
Overall Status
Completed
CT.gov ID
NCT00087178
Collaborator
National Cancer Institute (NCI) (NIH)
2,722
606
2
144
4.5
0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, epirubicin, cyclophosphamide, and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer.

PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating women who have undergone surgery for breast cancer that has not spread to the lymph nodes.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

OBJECTIVES:

Primary

  • Compare disease-free survival of women with node-negative breast cancer treated with adjuvant fluorouracil, epirubicin, and cyclophosphamide vs doxorubicin and cyclophosphamide.

Secondary

  • Compare survival, recurrence-free interval, and distant recurrence-free interval in patients treated with these regimens.

  • Compare adverse events in patients treated with these regimens.

  • Compare quality of life, with regard to physical functioning, vitality, symptoms, and rates of post-chemotherapy amenorrhea, in premenopausal patients treated with these regimens.

  • Determine the effect of induction of post-chemotherapy amenorrhea on disease-free survival in premenopausal patients treated with these regimens.

  • Correlate post-chemotherapy amenorrhea and disease-free survival with hormone receptor status in premenopausal patients treated with these regimens.

  • Correlate changes in left ventricular ejection fraction (LVEF) with self-reported physical functioning in patients treated with these regimens.

  • Compare the efficacy of these regimens in patients with Human Epidermal Growth Factor Receptor 2 (HER2)/neu and/or topoisomerase-2-alpha gene amplification.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to hormone receptor status (estrogen receptor [ER] positive or progesterone receptor [PR] positive vs ER negative or PR negative) and type of prior surgery (lumpectomy vs total mastectomy). Patients are randomized to 1 of 2 treatment arms.

  • Arm 1: Patients receive doxorubicin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.

  • Arm 2: Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

All patients with ER- or PR-positive tumors receive hormonal therapy daily beginning within 3-12 weeks after the completion of chemotherapy and continuing for at least 5 years.

All patients who have undergone prior lumpectomy undergo whole-breast radiotherapy beginning as soon as possible after the completion of chemotherapy. Patients who have undergone prior total mastectomy may undergo chest wall radiotherapy at the investigator's discretion. Patients assigned to the partial breast irradiation (PBI) group of protocol NSABP-B-39 undergo PBI according to protocol-specific guidelines.

Quality of life is assessed at baseline, on day 1 of course 4 of chemotherapy, and then every 6 months for 3 years.

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

PROJECTED ACCRUAL: A total of 2,700 patients (1,350 per treatment arm) will be accrued for this study within 3.75 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
2722 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Trial Of Adjuvant Therapy Comparing Six Cycles Of 5-Fluorouracil, Epirubicin And Cyclophosphamide (FEC) To Four Cycles Of Adriamycin And Cyclophosphamide (AC) In Patients With Node-Negative Breast Cancer
Study Start Date :
May 1, 2004
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1: adriamycin + cyclophosphamide

Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.

Drug: cyclophosphamide
Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles

Drug: adriamycin
adriamycin 60 mg/m2 IV every 21 days for 4 cycles
Other Names:
  • doxorubicin
  • doxorubicin hydrochloride
  • Experimental: Arm 2: fluorouracil + epirubicin + cyclophosphamide

    Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

    Drug: cyclophosphamide
    Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles

    Drug: epirubicin
    epirubicin 100 mg/m2 IV every 21 days for 6 cycles
    Other Names:
  • epirubicin hydrochloride
  • Drug: fluorouracil
    fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Other Names:
  • 5-fluorouracil
  • 5-FU
  • Outcome Measures

    Primary Outcome Measures

    1. Disease Free Survival [9 years]

      Percentage of patients free from DFS event. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer

    Secondary Outcome Measures

    1. Survival [9 years]

      Percentage of patients alive

    2. Adverse Events [9 years]

      Percentage of patients with at least one grade 2 or higher adverse event reported

    3. Quality of Life-Functional Assessment of Cancer Therapy [12 months]

      Functional Assessment of Cancer Therapy (FACT-B) trial outcome index (TOI) score. FACT-B TOI score ranges from 0 to 92, with a higher score indicating better QOL.

    4. Post Chemotherapy Amenorrhea [18 months]

      Percent with post chemotherapy amenorrhea

    5. Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation [12 months]

      Change in LVEF from randomization to 12 months

    6. HER-2 and Topo II Gene Amplification [6 years]

    7. Recurrence-free Interval [9 years]

      Percentage of patients with local-regional recurrence or distant recurrence

    8. Distant Recurrence-free Interval [9 years]

      Percentage of patients with distant recurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    Eligibility

    • Patients must be greater than or equal to 18 years of age.

    • The patient must have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer. (Comorbid conditions and performance status should be taken into consideration, but not the diagnosis of breast cancer.)

    • The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, sentinel lymph node biopsy, axillary surgery, or re-excision of lumpectomy margins) and randomization must be no more than 84 days.

    • The tumor must be invasive adenocarcinoma on histologic examination. (Patients with tumors that are pure tubular or mucinous adenocarcinomas are not eligible.)

    • The primary tumor must be T1-3 by clinical and pathologic evaluation.

    • Lymph nodes obtained from all axillary staging procedures must be pN0 according to pathologic staging criteria of the 6th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual.

    • Patients must have undergone axillary nodal staging procedures, for example sentinel node (SN) biopsy alone, SN biopsy followed by axillary sampling or completion dissection, or axillary node dissection to obtain lymph nodes for pathologic evaluation. If the patient has palpable nodes, axillary dissection is required.

    • Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER is negative, then progesterone receptor (PgR) analysis must be performed. If ER is positive, PgR analysis is desired, but not mandatory. ("Marginal" or "borderline" results [i.e., those not definitively negative] will be considered positive regardless of the methodology used.)

    • Patients must have had either a lumpectomy or total mastectomy.

    • Patients must have no clinical or radiologic evidence of metastatic disease.

    • Patients with skeletal pain are eligible for inclusion in the study if bone scan or roentgenological examination fail to disclose metastatic disease. Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy.

    • The patient's menopausal status must be determined prior to randomization.

    • Pre- and postmenopausal women are eligible. The following criteria will be used to define postmenopausal:

    • a prior documented bilateral oophorectomy, or

    • a history of at least 12 months without spontaneous menstrual bleeding, or

    • age 55 or older with a prior hysterectomy or

    • age 54 or younger with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the lab's postmenopausal range.

    • Women failing to meet one of these criteria will be classified as premenopausal.

    • At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray or chest CT within the past 3 months; bilateral mammogram within the past 6 months; and pelvic exam (for women who have a uterus and who will be receiving tamoxifen) within the past year.

    • Within 3 months prior to entry, the patient must have a baseline LVEF measured by Multi Gated Acquisition (MUGA) scan or echocardiogram equal to or greater than the lower limit of normal for the facility performing the procedure.

    • At the time of randomization:

    • The postoperative absolute granulocyte count (AGC) must be greater than or equal to 1500/mm3 (or greater than or equal to 1200/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variant of normal).

    • Postoperative platelet count must be greater than or equal to 100,000/mm3. Significant underlying hematologic disorders must be excluded when the platelet count is above the ULN for the lab.

    • There must be postoperative evidence of adequate hepatic function, i.e.,

    • total bilirubin must be less than or equal to ULN for the lab unless the patient has a chronic Grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and

    • alkaline phosphatase must be less than 2.5 x ULN for the lab; and

    • the aspartate transaminase (AST) [serum glutamic-oxaloacetic transaminase (SGOT)] must be less than or equal to 1.5 x ULN for the lab.

    • There must be postoperative evidence of normal renal function (serum creatinine less than or equal to ULN).

    • Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

    • Special conditions for eligibility of lumpectomy patients: radiation therapy and surgery Patients treated by lumpectomy followed by breast radiation therapy must meet all the eligibility criteria in addition to the following:

    • Generally, lumpectomy should be reserved for tumors less than 5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors greater than or equal to 5 cm are eligible if eligibility criteria for lumpectomy are met.

    • The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible.

    • This is a node-negative study, therefore irradiation of regional lymph nodes is prohibited in this trial.

    • Whole breast irradiation is required unless the patient is assigned to the partial breast irradiation group on NSABP B-39.

    • Postmastectomy chest wall irradiation at the investigator's discretion is permitted. However, this is a node-negative study; therefore irradiation of regional lymph nodes is prohibited in this trial.

    Ineligibility

    • Male patients are not eligible for this study.

    • Pure tubular or mucinous adenocarcinomas.

    • Bilateral malignancy (including DCIS) or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.

    • Primary tumor staged as T4 for any reason.

    • Suspicious palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes. Patients with these conditions are considered ineligible unless there is biopsy evidence that these are not involved with tumor.

    • Prior history of breast cancer, including DCIS (patients with a history of lobular carcinoma in situ [LCIS] are eligible).

    • Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization.

    The only exceptions are:
    • Hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before randomization and be re-started, if indicated, following chemotherapy.

    • If patient is enrolled in NSABP B-39 and randomized to Group 2, partial breast irradiation (PBI) may be completed prior to beginning treatment on NSABP B-36.

    • Prior anthracycline therapy for any malignancy.

    • Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc.. (These patients are eligible if this therapy is discontinued prior to randomization.)

    • Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to randomization. With the exception of tamoxifen, these medications are not permitted while on the study.)

    • Cardiac disease that would preclude the use of anthracyclines. This includes:

    • any documented myocardial infarction;

    • angina pectoris that requires the use of anti-anginal medication;

    • any history of documented congestive heart failure;

    • serious cardiac arrhythmia requiring medication,

    • severe conduction abnormality;

    • valvular disease with documented cardiac function compromise; and

    • poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. (Patients with hypertension that is well controlled on medication are eligible for entry.)

    • Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.

    • Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception.

    • Concurrent treatment with investigational agents.

    • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

    • Special conditions for ineligibility of lumpectomy patients: radiation therapy and surgery. For patients treated by lumpectomy, breast irradiation is required. The following patients will be ineligible:

    • Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy. (These patients are eligible if they undergo mastectomy.)

    • Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.

    • Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clearview Cancer Institute Huntsville Alabama United States 35805
    2 Providence Cancer Center Anchorage Alaska United States 99508
    3 Banner Thunderbird Medical Center Glendale Arizona United States 85306
    4 Banner Good Samaritan Medical Center Phoenix Arizona United States 85006
    5 CCOP - Western Regional, Arizona Phoenix Arizona United States 85006
    6 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Alta Bates Summit Comprehensive Cancer Center Berkeley California United States 94704
    8 Peninsula Medical Center Burlingame California United States 94010
    9 East Bay Radiation Oncology Center Castro Valley California United States 94546
    10 Valley Medical Oncology Consultants - Castro Valley Castro Valley California United States 94546
    11 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    12 North Bay Cancer Center Fairfield California United States 94533
    13 Kaiser Permanente - Fremont Fremont California United States 94538
    14 Valley Medical Oncology Fremont California United States 94538
    15 Glendale Memorial Hospital Comprehensive Cancer Center Glendale California United States 91204
    16 California Cancer Care, Incorporated - Greenbrae Greenbrae California United States 94904
    17 Marin Cancer Institute at Marin General Hospital Greenbrae California United States 94904
    18 Sutter Health - Western Division Cancer Research Group Greenbrae California United States 94904
    19 Kaiser Permanente Medical Center - Hayward Hayward California United States 94545
    20 Scripps Cancer Center - San Diego La Jolla California United States 92037
    21 Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda California United States 92354
    22 Pacific Shores Medical Group - Long Beach Long Beach California United States 90813
    23 Jonsson Comprehensive Cancer Center at UCLA Los Angeles California United States 90095-1781
    24 Highland General Hospital Oakland California United States 94602
    25 Alta Bates Summit Medical Center - Summit Campus Oakland California United States 94609
    26 Bay Area Breast Surgeons, Incorporated Oakland California United States 94609
    27 CCOP - Bay Area Tumor Institute Oakland California United States 94609
    28 Larry G Strieff MD Medical Corporation Oakland California United States 94609
    29 Tom K Lee, Incorporated Oakland California United States 94609
    30 Kaiser Permanente Medical Center - Oakland Oakland California United States 94611
    31 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange California United States 92868
    32 Valley Care Medical Center Pleasanton California United States 94588
    33 Valley Medical Oncology Consultants - Pleasanton Pleasanton California United States 94588
    34 North Valley Breast Clinic Redding California United States 96001
    35 Kaiser Permanente Medical Center - Redwood City Redwood City California United States 94063
    36 Kaiser Permanente Medical Center - Richmond Richmond California United States 94801
    37 Kaiser Permanente Medical Center - Roseville Roseville California United States 95661
    38 Sutter Cancer Center at Roseville Medical Center Roseville California United States 95661
    39 Sutter Cancer Center Sacramento California United States 95816
    40 South Sacramento Kaiser-Permanente Medical Center Sacramento California United States 95823
    41 Kaiser Permanente Medical Center - Sacramento Sacramento California United States 95825
    42 Kaiser Permanente Medical Office -Vandever Medical Office San Diego California United States 92120
    43 Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco California United States 94115
    44 California Pacific Medical Center - California Campus San Francisco California United States 94118
    45 Kaiser Permanente Medical Center - Santa Teresa San Jose California United States 95119
    46 Doctors Medical Center - San Pablo Campus San Pablo California United States 94806
    47 Kaiser Foundation Hospital - San Rafael San Rafael California United States 94903
    48 Cancer Center of Santa Barbara Santa Barbara California United States 93105
    49 Kaiser Permanente Medical Center - Santa Clara Kiely Campus Santa Clara California United States 95051
    50 Kaiser Permanente Medical Center - Santa Rosa Santa Rosa California United States 95403
    51 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95405
    52 Kaiser Permanente Medical Center - South San Francisco South San Francisco California United States 94080
    53 Stanford Cancer Center Stanford California United States 94305-5824
    54 Kaiser Permanente Medical Facility - Stockton Stockton California United States 95210
    55 Kaiser Permanente Medical Center - Vallejo Vallejo California United States 94589
    56 Sutter Solano Medical Center Vallejo California United States 94589
    57 Kaiser Permanente Medical Center - Walnut Creek Walnut Creek California United States 94596
    58 Aurora Presbyterian Hospital Aurora Colorado United States 80012
    59 Boulder Community Hospital Boulder Colorado United States 80301-9019
    60 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado United States 80933
    61 St. Anthony Central Hospital Denver Colorado United States 80204
    62 Porter Adventist Hospital Denver Colorado United States 80210
    63 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
    64 St. Joseph Hospital Denver Colorado United States 80218
    65 Rose Medical Center Denver Colorado United States 80220
    66 CCOP - Colorado Cancer Research Program Denver Colorado United States 80224-2522
    67 Swedish Medical Center Englewood Colorado United States 80110
    68 Poudre Valley Hospital Fort Collins Colorado United States 80524
    69 Front Range Cancer Specialists Fort Collins Colorado United States 80528
    70 St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction Colorado United States 81502
    71 North Colorado Medical Center Greeley Colorado United States 80631
    72 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    73 Hope Cancer Care Center at Longmont United Hospital Longmont Colorado United States 80502
    74 McKee Medical Center Loveland Colorado United States 80539
    75 St. Mary - Corwin Regional Medical Center Pueblo Colorado United States 81004
    76 North Suburban Medical Center Thornton Colorado United States 80229
    77 Exempla Lutheran Medical Center Wheat Ridge Colorado United States 80033
    78 Helen and Harry Gray Cancer Center at Hartford Hospital Hartford Connecticut United States 06102-5037
    79 Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut United States 06360
    80 Kent General Hospital Dover Delaware United States 19901
    81 Tunnell Cancer Center at Beebe Medical Center Lewes Delaware United States 19958
    82 CCOP - Christiana Care Health Services Newark Delaware United States 19713
    83 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia United States 20007
    84 Washington Cancer Institute at Washington Hospital Center Washington District of Columbia United States 20010
    85 Sibley Memorial Hospital Washington District of Columbia United States 20016
    86 Morton Plant Hospital Clearwater Florida United States 33756
    87 Herbert D. Kerman Regional Oncology Center - Daytona Beach Daytona Beach Florida United States 32115
    88 Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida United States 33308
    89 Broward General Medical Center Cancer Center Fort Lauderdale Florida United States 33316
    90 Memorial Cancer Institute at Memorial Regional Hospital Hollywood Florida United States 33021
    91 Baptist Cancer Institute - Jacksonville Jacksonville Florida United States 32207
    92 Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter Florida United States 33458
    93 Center for Cancer Care and Research at Watson Clinic, LLP Lakeland Florida United States 33805
    94 Lakeland Regional Cancer Center at Lakeland Regional Medical Center Lakeland Florida United States 33805
    95 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
    96 M.D. Anderson Cancer Center at Orlando Orlando Florida United States 32806
    97 Florida Cancer Specialists - Sarasota Downtown Sarasota Florida United States 34236
    98 Piedmont Hospital Atlanta Georgia United States 30309
    99 Northside Hospital Cancer Center Atlanta Georgia United States 30342-1611
    100 Saint Joseph's Hospital of Atlanta Atlanta Georgia United States 30342-1701
    101 CCOP - Atlanta Regional Atlanta Georgia United States 30342
    102 Augusta Oncology Associates - Walton Way Augusta Georgia United States 30901
    103 MBCCOP - Medical College of Georgia Cancer Center Augusta Georgia United States 30912
    104 WellStar Cobb Hospital Austell Georgia United States 30106
    105 Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur Georgia United States 30033
    106 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
    107 Northeast Georgia Medical Center Gainesville Georgia United States 30501
    108 Gwinnett Medical Center Lawrenceville Georgia United States 30045
    109 Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta Georgia United States 30060
    110 Southern Regional Medical Center Riverdale Georgia United States 30274-2600
    111 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia United States 31403-3089
    112 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah Georgia United States 31405
    113 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    114 Queen's Cancer Institute at Queen's Medical Center Honolulu Hawaii United States 96813
    115 Straub Clinic and Hospital, Incorporated Honolulu Hawaii United States 96813
    116 Hawaii Medical Center - East Honolulu Hawaii United States 96817
    117 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    118 Saint Anthony's Hospital at Saint Anthony's Health Center Alton Illinois United States 62002
    119 Rush-Copley Cancer Care Center Aurora Illinois United States 60504
    120 St. Joseph Medical Center Bloomington Illinois United States 61701
    121 Graham Hospital Canton Illinois United States 61520
    122 Memorial Hospital Carthage Illinois United States 62321
    123 John H. Stroger, Jr. Hospital of Cook County Chicago Illinois United States 60612-3785
    124 Creticos Cancer Center at Advocate Illinois Masonic Medical Center Chicago Illinois United States 60657
    125 Decatur Memorial Hospital Cancer Care Institute Decatur Illinois United States 62526
    126 Sherman Hospital Elgin Illinois United States 60120
    127 Alexian Brothers Radiation Oncology Elk Grove Village Illinois United States 60007
    128 Eureka Community Hospital Eureka Illinois United States 61530
    129 Evanston Northwestern Healthcare - Evanston Hospital Evanston Illinois United States 60201-1781
    130 Galesburg Clinic, PC Galesburg Illinois United States 61401
    131 Galesburg Cottage Hospital Galesburg Illinois United States 61401
    132 Delnor Community Hospital - Geneva Geneva Illinois United States 60134
    133 Mason District Hospital Havana Illinois United States 62644
    134 Hinsdale Hematology Oncology Associates Hinsdale Illinois United States 60521
    135 Hopedale Medical Complex Hopedale Illinois United States 61747
    136 Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois United States 60435
    137 Provena St. Mary's Regional Cancer Center - Kankakee Kankakee Illinois United States 60901
    138 La Grange Memorial Hospital La Grange Illinois United States 60525
    139 McDonough District Hospital Macomb Illinois United States 61455
    140 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    141 BroMenn Regional Medical Center Normal Illinois United States 61761
    142 Community Cancer Center Normal Illinois United States 61761
    143 Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields Olympia Fields Illinois United States 60461
    144 Community Hospital of Ottawa Ottawa Illinois United States 61350
    145 Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois United States 61350
    146 Advocate Lutheran General Cancer Care Center Park Ridge Illinois United States 60068-1174
    147 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
    148 Proctor Hospital Peoria Illinois United States 61614
    149 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
    150 Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois United States 61615
    151 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    152 OSF St. Francis Medical Center Peoria Illinois United States 61637
    153 Illinois Valley Community Hospital Peru Illinois United States 61354
    154 Perry Memorial Hospital Princeton Illinois United States 61356
    155 Swedish-American Regional Cancer Center Rockford Illinois United States 61104-2315
    156 Center for Cancer Care at OSF Saint Anthony Medical Center Rockford Illinois United States 61108
    157 St. Margaret's Hospital Spring Valley Illinois United States 61362
    158 Regional Cancer Center at Memorial Medical Center Springfield Illinois United States 62781-0001
    159 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
    160 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    161 St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana United States 46107
    162 Elkhart General Hospital Elkhart Indiana United States 46515
    163 Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana United States 46815
    164 Methodist Cancer Center at Methodist Hospital Indianapolis Indiana United States 46202
    165 Howard Community Hospital Kokomo Indiana United States 46904
    166 Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana United States 46350
    167 Clarian Arnett Cancer Care Lafayette Indiana United States 47904
    168 Saint Anthony Memorial Health Centers Michigan City Indiana United States 46360
    169 Community Hospital Munster Indiana United States 46321
    170 Reid Hospital & Health Care Services Richmond Indiana United States 47374
    171 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
    172 Memorial Hospital of South Bend South Bend Indiana United States 46601
    173 Saint Joseph Regional Medical Center South Bend Indiana United States 46617
    174 McFarland Clinic, PC Ames Iowa United States 50010
    175 Hematology Oncology Associates of the Quad Cities Bettendorf Iowa United States 52722
    176 Genesis Regional Cancer Center at Genesis Medical Center Davenport Iowa United States 52803
    177 Mercy Capitol Hospital Des Moines Iowa United States 50307
    178 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
    179 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
    180 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
    181 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
    182 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    183 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316
    184 Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa United States 52242-1002
    185 Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City Iowa United States 50401
    186 Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa United States 51101
    187 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
    188 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
    189 Covenant Cancer Treatment Center Waterloo Iowa United States 50702
    190 Cancer Center of Kansas, PA - Chanute Chanute Kansas United States 66720
    191 Cancer Center of Kansas, PA - Dodge City Dodge City Kansas United States 67801
    192 Cancer Center of Kansas, PA - El Dorado El Dorado Kansas United States 67042
    193 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    194 Providence Medical Center Kansas City Kansas United States 66112
    195 Cancer Center of Kansas, PA - Kingman Kingman Kansas United States 67068
    196 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    197 Southwest Medical Center Liberal Kansas United States 67901
    198 Cancer Center of Kansas, PA - Newton Newton Kansas United States 67114
    199 Menorah Medical Center Overland Park Kansas United States 66209
    200 Johnson County Radiation Therapy Overland Park Kansas United States 66210
    201 Cancer Center of Kansas, PA - Parsons Parsons Kansas United States 67357
    202 Cancer Center of Kansas, PA - Pratt Pratt Kansas United States 67124
    203 Cancer Center of Kansas, PA - Salina Salina Kansas United States 67042
    204 Shawnee Mission Medical Center Shawnee Mission Kansas United States 66204
    205 Cancer Center of Kansas, PA - Wellington Wellington Kansas United States 67152
    206 Associates in Womens Health, PA - North Review Wichita Kansas United States 67208
    207 Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas United States 67208
    208 Cancer Center of Kansas, PA - Wichita Wichita Kansas United States 67214
    209 CCOP - Wichita Wichita Kansas United States 67214
    210 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
    211 Cancer Center of Kansas, PA - Winfield Winfield Kansas United States 67156
    212 Cancer Resource Center at King's Daughters Medical Center Ashland Kentucky United States 41101-0151
    213 Lucille P. Markey Cancer Center at University of Kentucky Lexington Kentucky United States 40536-0093
    214 Louisville Oncology at Norton Cancer Institute - Louisville Louisville Kentucky United States 40202
    215 Baptist Hospital East - Louisville Louisville Kentucky United States 40207
    216 Pennington Cancer Center at Baton Rouge General Baton Rouge Louisiana United States 70806
    217 Ochsner Health Center - Bluebonnet Baton Rouge Louisiana United States 70809
    218 Terrebonne General Medical Center Houma Louisiana United States 70360
    219 Drs Gurtler Brinz and Russo APMC-Metairie Oncologists Metairie Louisiana United States 70006
    220 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    221 CCOP - Ochsner New Orleans Louisiana United States 70121
    222 Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    223 Christus Schumpert Cancer Treatment Center Shreveport Louisiana United States 71101
    224 Mercy Medical Center Baltimore Maryland United States 21202
    225 Greater Baltimore Medical Center Cancer Center Baltimore Maryland United States 21204
    226 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore Maryland United States 21215
    227 Harbor View Cancer Center at Harbor Hospital Baltimore Maryland United States 21225
    228 St. Agnes Hospital Cancer Center Baltimore Maryland United States 21229
    229 Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center Baltimore Maryland United States 21237
    230 Suburban Hospital Bethesda Maryland United States 20814
    231 Union Hospital Cancer Program at Union Hospital Elkton Maryland United States 21921
    232 Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility Largo Maryland United States 20774
    233 St. Mary's Hospital Leonardtown Maryland United States 20650
    234 Kaiser Permanente - Towson Lutherville Maryland United States 21093
    235 Kaiser Permanente Capital Area Medical Group - Shady Grove Facility Rockville Maryland United States 20850
    236 Peninsula Regional Medical Center Salisbury Maryland United States 21801
    237 Tufts-NEMC Cancer Center Boston Massachusetts United States 02111
    238 Boston University Cancer Research Center Boston Massachusetts United States 02118
    239 Commonwealth Hematology-Oncology, PC - Concord Concord Massachusetts United States 01742
    240 Commonwealth Hematology Oncology PC - Dorchester Dorchester Massachusetts United States 02124
    241 Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River Massachusetts United States 02721
    242 Commonwealth Hematology-Oncology, PC - Haverhill Haverhill Massachusetts United States 01830
    243 Commonwealth Hematology-Oncology, PC - Lawrence Lawrence Massachusetts United States 01842
    244 Commonwealth Hematology Oncology PC - Leominster Leominster Massachusetts United States 01453
    245 Commonwealth Hematology Oncology PC - Milton Milton Massachusetts United States 02186
    246 Berkshire Hematology Oncology, PC Pittsfield Massachusetts United States 01201
    247 Jordan Hospital Club Cancer Center Plymouth Massachusetts United States 02360
    248 Commonwealth Hematology-Oncology, PC - Quincy Quincy Massachusetts United States 02169
    249 Commonwealth Hematology-Oncology, PC - Stoneham Stoneham Massachusetts United States 02180
    250 Commonwealth Hematology-Oncology, PC - Weymouth Weymouth Massachusetts United States 02190
    251 Commonwealth Hematology-Oncology, PC - Worcester Worcester Massachusetts United States 01605
    252 Saint Joseph Mercy Cancer Center Ann Arbor Michigan United States 48106-0995
    253 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
    254 Battle Creek Health System Cancer Care Center Battle Creek Michigan United States 49017
    255 Bay Regional Medical Center Bay City Michigan United States 48708
    256 Mecosta County Medical Center Big Rapids Michigan United States 49307
    257 Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan United States 48123-2500
    258 Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan United States 48202
    259 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    260 Hurley Medical Center Flint Michigan United States 48503
    261 Great Lakes Cancer Institute at McLaren Regional Medical Center Flint Michigan United States 48532
    262 Butterworth Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    263 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
    264 Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan United States 49503
    265 Metro Health Hospital Grand Rapids Michigan United States 49506
    266 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
    267 Holland Community Hospital Holland Michigan United States 49423
    268 Foote Memorial Hospital Jackson Michigan United States 49201
    269 Borgess Medical Center Kalamazoo Michigan United States 49001
    270 West Michigan Cancer Center Kalamazoo Michigan United States 49007-3731
    271 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    272 Breslin Cancer Center at Ingham Regional Medical Center Lansing Michigan United States 48910
    273 Sparrow Regional Cancer Center Lansing Michigan United States 48912-1811
    274 Lapeer Regional Hospital Lapeer Michigan United States 48446
    275 St. Mary Mercy Hospital Livonia Michigan United States 48154
    276 Upper Michigan Cancer Center at Marquette General Hospital Marquette Michigan United States 49855
    277 Hackley Hospital Muskegon Michigan United States 49442
    278 St. Joseph Mercy Oakland Pontiac Michigan United States 48341-2985
    279 Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan United States 48060
    280 William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan United States 48073
    281 Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan United States 48601
    282 Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan United States 49085
    283 Oncology Care Associates, PLLC Saint Joseph Michigan United States 49085
    284 Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield Michigan United States 48075
    285 Munson Medical Center Traverse City Michigan United States 49684
    286 St. John Macomb Hospital Warren Michigan United States 48093
    287 MeritCare Bemidji Bemidji Minnesota United States 56601
    288 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    289 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
    290 St. Luke's Hospital Cancer Care Center Duluth Minnesota United States 55805
    291 Fairview Southdale Hospital Edina Minnesota United States 55435
    292 Fergus Falls Minnesota United States 56537
    293 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
    294 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
    295 Meeker County Memorial Hospital Litchfield Minnesota United States 55355
    296 HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota United States 55109
    297 Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota United States 55109
    298 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota United States 55407
    299 Hennepin County Medical Center - Minneapolis Minneapolis Minnesota United States 55415
    300 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota United States 55422-2900
    301 CentraCare Clinic - River Campus Saint Cloud Minnesota United States 56303
    302 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    303 Park Nicollet Cancer Center Saint Louis Park Minnesota United States 55416
    304 Regions Hospital Cancer Care Center Saint Paul Minnesota United States 55101
    305 HealthEast Cancer Care at St. Joseph's Hospital Saint Paul Minnesota United States 55102
    306 United Hospital Saint Paul Minnesota United States 55102
    307 St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota United States 55379
    308 Ridgeview Medical Center Waconia Minnesota United States 55387
    309 HealthEast Cancer Care at Woodwinds Health Campus Woodbury Minnesota United States 55125
    310 Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota United States 55125
    311 Hattiesburg Clinic, PA at Forrest General Hattiesburg Mississippi United States 39401
    312 Hematology & Oncology Clinic Hattiesburg Mississippi United States 39402
    313 Regional Cancer Center at Singing River Hospital Pascagoula Mississippi United States 39581
    314 Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Cape Girardeau Missouri United States 63701
    315 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    316 Saint Luke's Hospital Chesterfield Missouri United States 63017
    317 Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri United States 65203
    318 Independence Regional Health Center Independence Missouri United States 64050
    319 Freeman Cancer Institute at Freeman Health System Joplin Missouri United States 64804
    320 St. John's Regional Medical Center Joplin Missouri United States 64804
    321 Truman Medical Center - Hospital Hill Kansas City Missouri United States 64108
    322 Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri United States 64111
    323 Kansas City Cancer Center at St. Joseph's Medical Mall Kansas City Missouri United States 64114
    324 St. Joseph Medical Center Kansas City Missouri United States 64114
    325 North Kansas City Hospital Kansas City Missouri United States 64116
    326 Parvin Radiation Oncology Kansas City Missouri United States 64116
    327 CCOP - Kansas City Kansas City Missouri United States 64131
    328 Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center Kansas City Missouri United States 64154
    329 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    330 Midwest Hematology Oncology Group, Incorporated Saint Louis Missouri United States 63109
    331 Saint Louis University Cancer Center Saint Louis Missouri United States 63110
    332 Missouri Baptist Cancer Center Saint Louis Missouri United States 63131
    333 Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis Missouri United States 63141
    334 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    335 David C. Pratt Cancer Center at St. John's Mercy Saint Louis Missouri United States 63141
    336 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65802
    337 St. John's Regional Health Center Springfield Missouri United States 65804
    338 Hulston Cancer Center at Cox Medical Center South Springfield Missouri United States 65807
    339 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    340 Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana United States 59101
    341 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
    342 St. Vincent Healthcare Cancer Care Services Billings Montana United States 59101
    343 Billings Clinic - Downtown Billings Montana United States 59107-7000
    344 Bozeman Deaconess Cancer Center Bozeman Montana United States 59715
    345 St. James Healthcare Cancer Care Butte Montana United States 59701
    346 Big Sky Oncology Great Falls Montana United States 59405-5309
    347 Great Falls Clinic - Main Facility Great Falls Montana United States 59405
    348 Sletten Cancer Institute at Benefis Healthcare Great Falls Montana United States 59405
    349 Great Falls Montana United States 59405
    350 St. Peter's Hospital Helena Montana United States 59601
    351 Glacier Oncology, PLLC Kalispell Montana United States 59901
    352 Kalispell Medical Oncology at KRMC Kalispell Montana United States 59901
    353 Kalispell Regional Medical Center Kalispell Montana United States 59901
    354 Community Medical Center Missoula Montana United States 59801
    355 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
    356 Montana Cancer Specialists at Montana Cancer Center Missoula Montana United States 59807-7877
    357 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59807
    358 Cancer Resource Center - Lincoln Lincoln Nebraska United States 68510
    359 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    360 Methodist Estabrook Cancer Center Omaha Nebraska United States 68114
    361 Immanuel Medical Center Omaha Nebraska United States 68122
    362 Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska United States 68124
    363 Creighton University Medical Center Omaha Nebraska United States 68131-2197
    364 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    365 CCOP - Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    366 Renown Institute for Cancer at Renown Regional Medical Center Reno Nevada United States 89502
    367 Center for Cancer Care at Exeter Hospital Exeter New Hampshire United States 03833
    368 Hunterdon Regional Cancer Center at Hunterdon Medical Center Flemington New Jersey United States 08822
    369 Cancer Institute of New Jersey at Hamilton Hamilton New Jersey United States 08690
    370 Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton New Jersey United States 08053
    371 Mountainside Hospital Cancer Center Montclair New Jersey United States 07042
    372 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey United States 08903
    373 Saint Peter's University Hospital New Brunswick New Jersey United States 08903
    374 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    375 Warren Hospital Phillipsburg New Jersey United States 08865
    376 Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland New Jersey United States 08360
    377 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey United States 08043
    378 Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey United States 08043
    379 Hematology Oncology Associates, PC Albuquerque New Mexico United States 87106
    380 Lovelace Medical Center - Gibson Albuquerque New Mexico United States 87108
    381 University of New Mexico Cancer Center Albuquerque New Mexico United States 87131-5636
    382 New Mexico Cancer Care Associates Santa Fe New Mexico United States 87505
    383 New York Oncology Hematology, PC at Albany Regional Cancer Care Albany New York United States 12206
    384 New York Oncology Hematology, PC at Albany Medical Center Albany New York United States 12208
    385 Amsterdam Community Cancer Program Amsterdam New York United States 12010
    386 Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx New York United States 10461
    387 Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx New York United States 10466
    388 Finger Lakes Hematology and Oncology Clifton Springs New York United States 14432
    389 CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York United States 13057
    390 Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls New York United States 12801
    391 New York Oncology Hematology, PC - Hudson Hudson New York United States 12534
    392 Queens Cancer Center of Queens Hospital Jamaica New York United States 11432
    393 New York Oncology Hematology, PC - Latham Latham New York United States 12110
    394 CCOP - North Shore University Hospital Manhasset New York United States 11030
    395 Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York United States 11030
    396 Long Island Jewish Medical Center New Hyde Park New York United States 11042
    397 Riverview Cancer Care Medical Associates, PC Rexford New York United States 12148
    398 Samaritan Hospital at Northeast Health Troy New York United States 12180
    399 Randolph Hospital Asheboro North Carolina United States 27203-5400
    400 Mission Hospitals - Memorial Campus Asheville North Carolina United States 28801
    401 Alamance Cancer Center at Alamance Regional Medical Center Burlington North Carolina United States 27216
    402 Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina United States 28232-2861
    403 John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital Eden North Carolina United States 27288
    404 Cape Fear Valley Medical Center Cancer Center Fayetteville North Carolina United States 28302-2000
    405 CaroMont Cancer Center at Gaston Memorial Hospital Gastonia North Carolina United States 28053
    406 Wayne Memorial Hospital, Incorporated Goldsboro North Carolina United States 27534
    407 Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro North Carolina United States 27403-1198
    408 Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina United States 27835-6028
    409 Annie Penn Cancer Center Reidsville North Carolina United States 27320
    410 Rutherford Hospital Rutherfordton North Carolina United States 28139
    411 Marion L. Shepard Cancer Center at Beaufort County Hospital Washington North Carolina United States 27889
    412 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
    413 Bismarck Cancer Center Bismarck North Dakota United States 58501
    414 Medcenter One Hospital Cancer Care Center Bismarck North Dakota United States 58501
    415 Mid Dakota Clinic, PC Bismarck North Dakota United States 58501
    416 St. Alexius Medical Center Cancer Center Bismarck North Dakota United States 58502
    417 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
    418 MeritCare Broadway Fargo North Dakota United States 58122
    419 McDowell Cancer Center at Akron General Medical Center Akron Ohio United States 44307
    420 Summa Center for Cancer Care at Akron City Hospital Akron Ohio United States 44309-2090
    421 Mary Rutan Hospital Bellefontaine Ohio United States 43311
    422 Aultman Cancer Center at Aultman Hospital Canton Ohio United States 44710-1799
    423 Adena Regional Medical Center Chillicothe Ohio United States 45601
    424 Christ Hospital Cancer Center Cincinnati Ohio United States 45219
    425 Oncology Hematology Care, Incorporated - Blue Ash Cincinnati Ohio United States 45242
    426 Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio United States 45267
    427 Case Comprehensive Cancer Center Cleveland Ohio United States 44106-5065
    428 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio United States 43210-1240
    429 Riverside Methodist Hospital Cancer Care Columbus Ohio United States 43214-3998
    430 CCOP - Columbus Columbus Ohio United States 43215
    431 Grant Medical Center Cancer Care Columbus Ohio United States 43215
    432 Mount Carmel Health - West Hospital Columbus Ohio United States 43222
    433 Doctors Hospital at Ohio Health Columbus Ohio United States 43228
    434 Grandview Hospital Dayton Ohio United States 45405
    435 Good Samaritan Hospital Dayton Ohio United States 45406
    436 David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio United States 45409
    437 Samaritan North Cancer Care Center Dayton Ohio United States 45415
    438 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
    439 CCOP - Dayton Dayton Ohio United States 45429
    440 Grady Memorial Hospital Delaware Ohio United States 43015
    441 Middletown Regional Hospital Franklin Ohio United States 45005-1066
    442 Charles F. Kettering Memorial Hospital Kettering Ohio United States 45429
    443 Fairfield Medical Center Lancaster Ohio United States 43130
    444 St. Rita's Medical Center Lima Ohio United States 45801
    445 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio United States 45750
    446 Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio United States 43055
    447 Mercy Medical Center Springfield Ohio United States 45504
    448 Community Hospital of Springfield and Clark County Springfield Ohio United States 45505
    449 UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio United States 45373-1300
    450 Mount Carmel St. Ann's Cancer Center Westerville Ohio United States 43081
    451 Clinton Memorial Hospital Wilmington Ohio United States 45177
    452 Cancer Treatment Center Wooster Ohio United States 44691
    453 United States Air Force Medical Center - Wright-Patterson Wright-Patterson Air Force Base Ohio United States 45433-5529
    454 Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio United States 45385
    455 Tod Children's Hospital Youngstown Ohio United States 44501
    456 Genesis - Good Samaritan Hospital Zanesville Ohio United States 43701
    457 Cleo Craig Cancer Research Clinic Lawton Oklahoma United States 73505
    458 Oklahoma University Cancer Institute Oklahoma City Oklahoma United States 73104
    459 Cancer Care Associates - Mercy Campus Oklahoma City Oklahoma United States 73120
    460 LaFortune Cancer Center at St. John Medical Center Tulsa Oklahoma United States 74104
    461 Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma United States 74136
    462 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    463 Providence Milwaukie Hospital Milwaukie Oregon United States 97222
    464 Legacy Good Samaritan Hospital & Comprehensive Cancer Center Portland Oregon United States 97210
    465 Providence Cancer Center at Providence Portland Medical Center Portland Oregon United States 97213-2967
    466 Adventist Medical Center Portland Oregon United States 97216
    467 CCOP - Columbia River Oncology Program Portland Oregon United States 97225
    468 Providence St. Vincent Medical Center Portland Oregon United States 97225
    469 Legacy Emanuel Hospital and Health Center and Children's Hospital Portland Oregon United States 97227
    470 Kaiser Permanente Health Care - Portland Portland Oregon United States 97232
    471 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
    472 Rosenfeld Cancer Center at Abington Memorial Hospital Abington Pennsylvania United States 19001
    473 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania United States 18105
    474 Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center DuBois Pennsylvania United States 15801
    475 Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg Pennsylvania United States 18301
    476 Easton Regional Cancer Center at Easton Hospital Easton Pennsylvania United States 18042
    477 Ephrata Cancer Center at Ephrata Community Hospital Ephrata Pennsylvania United States 17522
    478 Regional Cancer Center - Erie Erie Pennsylvania United States 16505
    479 Saint Vincent Health Center Erie Pennsylvania United States 16544
    480 PinnacleHealth Regional Cancer Center at Polyclinic Hospital Harrisburg Pennsylvania United States 17110-2098
    481 Richard G. Laube Cancer Center at ACMH Kittanning Pennsylvania United States 16201
    482 Riddle Memorial Hospital Cancer Center Media Pennsylvania United States 19063
    483 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104-4283
    484 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    485 Frankford Hospital Cancer Center - Torresdale Campus Philadelphia Pennsylvania United States 19114
    486 Albert Einstein Cancer Center Philadelphia Pennsylvania United States 19141
    487 Allegheny Cancer Center at Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    488 Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224-1791
    489 UPMC Cancer Centers Pittsburgh Pennsylvania United States 15232
    490 Pottstown Memorial Regional Cancer Center Pottstown Pennsylvania United States 19464
    491 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading Pennsylvania United States 19612-6052
    492 Guthrie Cancer Center at Guthrie Clinic Sayre Sayre Pennsylvania United States 18840
    493 Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania United States 18501
    494 Hematology and Oncology Associates of Northeastern Pennsylvania Scranton Pennsylvania United States 18508
    495 Mount Nittany Medical Center State College Pennsylvania United States 16803
    496 Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center Upland Pennsylvania United States 19013
    497 York Cancer Center at Apple Hill Medical Center York Pennsylvania United States 17405
    498 Hematology and Oncology Associates of Rhode Island Cranston Rhode Island United States 02920
    499 Women and Infants Hospital of Rhode Island Providence Rhode Island United States 02905
    500 Kent County Memorial Hospital Warwick Rhode Island United States 02886
    501 AnMed Cancer Center Anderson South Carolina United States 29621
    502 CCOP - Greenville Greenville South Carolina United States 29615
    503 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    504 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
    505 Oncology Services of Aberdeen Aberdeen South Dakota United States 57401
    506 Rapid City Regional Hospital Rapid City South Dakota United States 57701
    507 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    508 Medical X-Ray Center, PC Sioux Falls South Dakota United States 57105
    509 Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota United States 57117-5039
    510 U.T. Medical Center Cancer Institute Knoxville Tennessee United States 37920-6999
    511 Texas Oncology - Midtown Austin Austin Texas United States 78705
    512 Texas Oncology, PA at Texas Oncology Cancer Center - Central Austin Texas United States 78731
    513 Texas Oncology, PA at South Austin Cancer Center Austin Texas United States 78745
    514 St. Joseph Regional Cancer Center Bryan Texas United States 77802
    515 Baylor University Medical Center - Houston Houston Texas United States 77030
    516 Joe Arrington Cancer Research and Treatment Center Lubbock Texas United States 79410-1894
    517 Texas Oncology, PA at Texas Cancer Center Round Rock Round Rock Texas United States 78681
    518 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229-3900
    519 CCOP - Scott and White Hospital Temple Texas United States 76508
    520 American Fork Hospital American Fork Utah United States 84003
    521 Sandra L. Maxwell Cancer Center Cedar City Utah United States 84720
    522 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray Utah United States 84157
    523 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden Utah United States 84403
    524 Utah Valley Regional Medical Center - Provo Provo Utah United States 84604
    525 Dixie Regional Medical Center - East Campus Saint George Utah United States 84770
    526 Utah Cancer Specialists at UCS Cancer Center Salt Lake City Utah United States 84106
    527 Huntsman Cancer Institute at University of Utah Salt Lake City Utah United States 84112
    528 LDS Hospital Salt Lake City Utah United States 84143
    529 Green Mountain Oncology Group Bennington Vermont United States 05201
    530 Kaiser Permanente Medical Center - Fair Oaks Fairfax Virginia United States 22033
    531 Virginia Oncology Associates - Hampton Hampton Virginia United States 23666
    532 Lynchburg Hematology-Oncology Clinic Lynchburg Virginia United States 24501
    533 Virginia Cancer Institute - West End Richmond Virginia United States 23230
    534 Virginia Commonwealth University Massey Cancer Center Richmond Virginia United States 23298-0037
    535 Carilion Cancer Center of Western Virginia Roanoke Virginia United States 24014
    536 Overlake Cancer Center at Overlake Hospital Medical Center Bellevue Washington United States 98004
    537 St. Joseph Cancer Center Bellingham Washington United States 98225
    538 Olympic Hematology and Oncology Bremerton Washington United States 98310
    539 St. Francis Hospital Federal Way Washington United States 98003
    540 Olympic Medical Center Port Angeles Washington United States 98362
    541 Good Samaritan Cancer Center Puyallup Washington United States 98372
    542 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    543 Fred Hutchinson Cancer Research Center Seattle Washington United States 98104
    544 Group Health Central Hospital Seattle Washington United States 98112
    545 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington United States 98122-4307
    546 Rockwood Clinic Cancer Treatment Center Spokane Washington United States 99204-2967
    547 Providence Cancer Center at Sacred Heart Medical Center Spokane Washington United States 99204
    548 Providence Cancer Center at Holy Family Hospital Spokane Washington United States 99207
    549 Cancer Care Northwest - North Spokane Washington United States 99218
    550 Franciscan Cancer Center at St. Joseph Medical Center Tacoma Washington United States 98405-3004
    551 Allenmore Hospital Tacoma Washington United States 98405
    552 CCOP - Northwest Tacoma Washington United States 98405
    553 St. Clare Hospital Tacoma Washington United States 98499
    554 Southwest Washington Medical Center Cancer Center Vancouver Washington United States 98668
    555 St. Mary Regional Cancer Center at St. Mary Medical Center Walla Walla Washington United States 99362
    556 Wenatchee Valley Medical Center Wenatchee Washington United States 98801-2028
    557 Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Huntington West Virginia United States 25701
    558 St. Mary's Regional Cancer Center at St. Mary's Medical Center Huntington West Virginia United States 25702
    559 Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown West Virginia United States 26506
    560 Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg West Virginia United States 26102
    561 Princeton Community Hospital Princeton West Virginia United States 24740
    562 Center for Cancer Treatment & Prevention at Sacred Heart Hospital Eau Claire Wisconsin United States 54701
    563 Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin United States 54701
    564 Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn Elkhorn Wisconsin United States 53121
    565 Central Wisconsin Cancer Program at Agnesian HealthCare Fond Du Lac Wisconsin United States 54935
    566 Oncology Alliance, SC - Milwaukee - East Glendale Wisconsin United States 53212-1038
    567 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54301-3526
    568 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
    569 St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin United States 54303
    570 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
    571 Dean Medical Center - Madison Madison Wisconsin United States 53717
    572 Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin United States 54143
    573 Marshfield Clinic - Marshfield Center Marshfield Wisconsin United States 54449
    574 Saint Joseph's Hospital Marshfield Wisconsin United States 54449
    575 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53201-0342
    576 Medical Consultants, Limited Milwaukee Wisconsin United States 53215
    577 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226
    578 Marshfield Clinic - Lakeland Center Minocqua Wisconsin United States 54548
    579 Ministry Medical Group at Saint Mary's Hospital Rhinelander Wisconsin United States 54501
    580 Marshfield Clinic - Indianhead Center Rice Lake Wisconsin United States 54868
    581 Saint Michael's Hospital Cancer Center Stevens Point Wisconsin United States 54481
    582 Vince Lombardi Cancer Clinic - Two Rivers Two Rivers Wisconsin United States 54241
    583 Marshfield Clinic - Wausau Center Wausau Wisconsin United States 54401
    584 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
    585 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    586 Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming United States 82801
    587 Tom Baker Cancer Centre - Calgary Calgary Alberta Canada T2N 4N2
    588 Cross Cancer Institute at University of Alberta Edmonton Alberta Canada T6G 1Z2
    589 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    590 Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2
    591 Trillium Health Centre - Mississauga Site Mississauga Ontario Canada L5B 1B8
    592 Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital Mississauga Ontario Canada L5M 2N1
    593 Ottawa Hospital Regional Cancer Centre - General Campus Ottawa Ontario Canada K1Y 4K7
    594 Edmond Odette Cancer Centre at Sunnybrook Toronto Ontario Canada M4N 3M5
    595 Maisonneuve-Rosemont Hospital Montreal Quebec Canada H1T 2M4
    596 Hopital Notre-Dame du CHUM Montreal Quebec Canada H2L 4M1
    597 CHUM - Hotel Dieu Hospital Montreal Quebec Canada H2W 1T8
    598 CHUM - Hopital Saint-Luc Montreal Quebec Canada H2X 3J4
    599 Royal Victoria Hospital - Montreal Montreal Quebec Canada H3A 1A1
    600 Montreal General Hospital Montreal Quebec Canada H3G 1A4
    601 Jewish General Hospital - Montreal Montreal Quebec Canada H3T 1E2
    602 Hopital du Saint-Sacrement - Quebec Quebec City Quebec Canada G1S 4L8
    603 Andres Grillasca Hospital Ponce Puerto Rico 00733
    604 Hato Rey Hematology/Oncology Group, PSC San Juan Puerto Rico 00917
    605 I. Gonzalez Martinez Oncologic Hospital San Juan Puerto Rico 00919
    606 San Juan City Hospital San Juan Puerto Rico 00928

    Sponsors and Collaborators

    • NSABP Foundation Inc
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Norman Wolmark, MD, NSABP Foundation Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NSABP Foundation Inc
    ClinicalTrials.gov Identifier:
    NCT00087178
    Other Study ID Numbers:
    • NSABP B-36
    • U10CA012027
    First Posted:
    Jul 12, 2004
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Aug 1, 2022

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Arm 1: Adriamycin + Cyclophosphamide Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Period Title: Overall Study
    STARTED 1361 1361
    COMPLETED 1355 1343
    NOT COMPLETED 6 18

    Baseline Characteristics

    Arm/Group Title Arm 1- Adriamycin + Cyclophosphamide Arm 2 - Fluorouracil + Epirubicin + Cyclophosphamide Total
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1:cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubican IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles Total of all reporting groups
    Overall Participants 1361 1361 2722
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52
    (9.4)
    52
    (9.6)
    52
    (9.5)
    Sex: Female, Male (Count of Participants)
    Female
    1361
    100%
    1361
    100%
    2722
    100%
    Male
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Disease Free Survival
    Description Percentage of patients free from DFS event. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer
    Time Frame 9 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm 1: Adriamycin + Cyclophosphamide Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Measure Participants 1355 1343
    Number [percentage of participants]
    80.1
    5.9%
    79.4
    5.8%
    2. Secondary Outcome
    Title Survival
    Description Percentage of patients alive
    Time Frame 9 years

    Outcome Measure Data

    Analysis Population Description
    Patients with any type of follow-up.
    Arm/Group Title Arm 1: Adriamycin + Cyclophosphamide Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Measure Participants 1356 1345
    Number [percentage of participants alive]
    89.8
    6.6%
    89.9
    6.6%
    3. Secondary Outcome
    Title Adverse Events
    Description Percentage of patients with at least one grade 2 or higher adverse event reported
    Time Frame 9 years

    Outcome Measure Data

    Analysis Population Description
    Patients with follow-up and available adverse event information.
    Arm/Group Title Arm 1: Adriamycin + Cyclophosphamide Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Measure Participants 1349 1333
    Number [percentage of participants]
    28.5
    2.1%
    45.0
    3.3%
    4. Secondary Outcome
    Title Quality of Life-Functional Assessment of Cancer Therapy
    Description Functional Assessment of Cancer Therapy (FACT-B) trial outcome index (TOI) score. FACT-B TOI score ranges from 0 to 92, with a higher score indicating better QOL.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Patients who participated in the QOL sub-study
    Arm/Group Title Arm 1: Adriamycin + Cyclophosphamide Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Measure Participants 675 656
    Score day 1 cycle 4
    61.7
    60.3
    Score 6 months
    69.2
    66.9
    Score 12 months
    71.7
    71.1
    5. Secondary Outcome
    Title Post Chemotherapy Amenorrhea
    Description Percent with post chemotherapy amenorrhea
    Time Frame 18 months

    Outcome Measure Data

    Analysis Population Description
    Patients who participated in the Menstrual History sub-study
    Arm/Group Title Arm 1: Adriamycin + Cyclophosphamide Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Measure Participants 474 451
    Number [percentage of participants]
    59.1
    4.3%
    67.4
    5%
    6. Secondary Outcome
    Title Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation
    Description Change in LVEF from randomization to 12 months
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Patients who participated in the cardiac function sub-study
    Arm/Group Title Arm 1: Adriamycin + Cyclophosphamide Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Measure Participants 159 146
    Mean (95% Confidence Interval) [Change in percent ejection fraction]
    -2.61
    -2.65
    7. Secondary Outcome
    Title HER-2 and Topo II Gene Amplification
    Description
    Time Frame 6 years

    Outcome Measure Data

    Analysis Population Description
    Data were not collected. Gene amplification analysis was not performed on the submitted blocks.
    Arm/Group Title Arm 1: Adriamycin + Cyclophosphamide Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Measure Participants 0 0
    8. Secondary Outcome
    Title Recurrence-free Interval
    Description Percentage of patients with local-regional recurrence or distant recurrence
    Time Frame 9 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm 1: Adriamycin + Cyclophosphamide Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Measure Participants 1355 1343
    Number [percentage of participants]
    10.8
    0.8%
    10.4
    0.8%
    9. Secondary Outcome
    Title Distant Recurrence-free Interval
    Description Percentage of patients with distant recurrence
    Time Frame 9 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm 1: Adriamycin + Cyclophosphamide Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    Measure Participants 1355 1343
    Number [percentage of participants]
    8.3
    0.6%
    7.2
    0.5%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Participants at Risk includes any patient who submitted an AE form.
    Arm/Group Title Adriamycin + Cyclophosphamide Fluorouracil + Epirubicin + Cyclophosphamide
    Arm/Group Description Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
    All Cause Mortality
    Adriamycin + Cyclophosphamide Fluorouracil + Epirubicin + Cyclophosphamide
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Adriamycin + Cyclophosphamide Fluorouracil + Epirubicin + Cyclophosphamide
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/1351 (0.9%) 26/1337 (1.9%)
    Blood and lymphatic system disorders
    Anemia 0/1351 (0%) 1/1337 (0.1%)
    Disseminated intravascular coagulation 1/1351 (0.1%) 0/1337 (0%)
    Febrile neutropenia 0/1351 (0%) 1/1337 (0.1%)
    Cardiac disorders
    Atrial fibrillation 1/1351 (0.1%) 1/1337 (0.1%)
    Heart failure 0/1351 (0%) 1/1337 (0.1%)
    Pericardial effusion 0/1351 (0%) 1/1337 (0.1%)
    Pericarditis 0/1351 (0%) 1/1337 (0.1%)
    Left ventricular systolic dysfunction 0/1351 (0%) 2/1337 (0.1%)
    Gastrointestinal disorders
    Colonic perforation 0/1351 (0%) 1/1337 (0.1%)
    Diarrhea 0/1351 (0%) 1/1337 (0.1%)
    Mucositis oral 0/1351 (0%) 1/1337 (0.1%)
    Nausea 0/1351 (0%) 1/1337 (0.1%)
    Vomiting 0/1351 (0%) 1/1337 (0.1%)
    General disorders
    Sudden death NOS 1/1351 (0.1%) 2/1337 (0.1%)
    Infections and infestations
    Infections and infestations - Other, specify 0/1351 (0%) 1/1337 (0.1%)
    Enterocolitis infectious 1/1351 (0.1%) 0/1337 (0%)
    Mucosal infection 1/1351 (0.1%) 0/1337 (0%)
    Investigations
    Neutrophil count decreased 1/1351 (0.1%) 2/1337 (0.1%)
    Platelet count decreased 3/1351 (0.2%) 4/1337 (0.3%)
    White blood cell decreased 0/1351 (0%) 1/1337 (0.1%)
    Metabolism and nutrition disorders
    Hyperglycemia 0/1351 (0%) 1/1337 (0.1%)
    Hyperkalemia 0/1351 (0%) 2/1337 (0.1%)
    Hypocalcemia 1/1351 (0.1%) 0/1337 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Leukemia secondary to oncology chemotherapy 3/1351 (0.2%) 2/1337 (0.1%)
    Treatment related secondary malignancy 1/1351 (0.1%) 2/1337 (0.1%)
    Nervous system disorders
    Stroke 0/1351 (0%) 2/1337 (0.1%)
    Syncope 0/1351 (0%) 1/1337 (0.1%)
    Psychiatric disorders
    Agitation 1/1351 (0.1%) 0/1337 (0%)
    Anxiety 1/1351 (0.1%) 1/1337 (0.1%)
    Depression 0/1351 (0%) 1/1337 (0.1%)
    Renal and urinary disorders
    Acute kidney injury 0/1351 (0%) 1/1337 (0.1%)
    Reproductive system and breast disorders
    Uterine hemorrhage 0/1351 (0%) 1/1337 (0.1%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/1351 (0%) 1/1337 (0.1%)
    Dyspnea 0/1351 (0%) 1/1337 (0.1%)
    Pleural effusion 1/1351 (0.1%) 1/1337 (0.1%)
    Respiratory failure 0/1351 (0%) 1/1337 (0.1%)
    Vascular disorders
    Thromboembolic event 1/1351 (0.1%) 4/1337 (0.3%)
    Other (Not Including Serious) Adverse Events
    Adriamycin + Cyclophosphamide Fluorouracil + Epirubicin + Cyclophosphamide
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 290/1351 (21.5%) 454/1337 (34%)
    Blood and lymphatic system disorders
    Anemia 106/1351 (7.8%) 147/1337 (11%)
    Febrile neutropenia 50/1351 (3.7%) 127/1337 (9.5%)
    Gastrointestinal disorders
    Mucositis oral 42/1351 (3.1%) 81/1337 (6.1%)
    Nausea 94/1351 (7%) 121/1337 (9.1%)
    Vomiting 62/1351 (4.6%) 99/1337 (7.4%)
    General disorders
    Fatigue 118/1351 (8.7%) 165/1337 (12.3%)
    Investigations
    Neutrophil count decreased 80/1351 (5.9%) 92/1337 (6.9%)
    Platelet count decreased 25/1351 (1.9%) 84/1337 (6.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Director, Department of Regulatory Affairs
    Organization NRG Oncololgy
    Phone 412-339-5300
    Email langerj@nrgoncology.org
    Responsible Party:
    NSABP Foundation Inc
    ClinicalTrials.gov Identifier:
    NCT00087178
    Other Study ID Numbers:
    • NSABP B-36
    • U10CA012027
    First Posted:
    Jul 12, 2004
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Aug 1, 2022