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

August 10, 2022 updated by: NSABP Foundation Inc

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

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2722

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre - Calgary
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute at University of Alberta
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - CancerCare Manitoba
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- Ontario
  - Mississauga, Ontario, Canada, L5B 1B8
    - Trillium Health Centre - Mississauga Site
  - Mississauga, Ontario, Canada, L5M 2N1
    - Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital
  - Ottawa, Ontario, Canada, K1Y 4K7
    - Ottawa Hospital Regional Cancer Centre - General Campus
  - Toronto, Ontario, Canada, M4N 3M5
    - Edmond Odette Cancer Centre at Sunnybrook
- Quebec
  - Montreal, Quebec, Canada, H1T 2M4
    - Maisonneuve-Rosemont Hospital
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital
  - Montreal, Quebec, Canada, H3A 1A1
    - Royal Victoria Hospital - Montreal
  - Montreal, Quebec, Canada, H3T 1E2
    - Jewish General Hospital - Montreal
  - Montreal, Quebec, Canada, H2L 4M1
    - Hopital Notre-Dame du CHUM
  - Montreal, Quebec, Canada, H2W 1T8
    - CHUM - Hotel Dieu Hospital
  - Montreal, Quebec, Canada, H2X 3J4
    - CHUM - Hopital Saint-Luc
  - Quebec City, Quebec, Canada, G1S 4L8
    - Hopital du Saint-Sacrement - Quebec
Puerto Rico
- - Ponce, Puerto Rico, 00733
    - Andres Grillasca Hospital
  - San Juan, Puerto Rico, 00928
    - San Juan City Hospital
  - San Juan, Puerto Rico, 00917
    - Hato Rey Hematology/Oncology Group, PSC
  - San Juan, Puerto Rico, 00919
    - I. Gonzalez Martinez Oncologic Hospital
United States
- Alabama
  - Huntsville, Alabama, United States, 35805
    - Clearview Cancer Institute
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Providence Cancer Center
- Arizona
  - Glendale, Arizona, United States, 85306
    - Banner Thunderbird Medical Center
  - Phoenix, Arizona, United States, 85006
    - Banner Good Samaritan Medical Center
  - Phoenix, Arizona, United States, 85006
    - CCOP - Western Regional, Arizona
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Comprehensive Cancer Center
  - Burlingame, California, United States, 94010
    - Peninsula Medical Center
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants - Castro Valley
  - Duarte, California, United States, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - Fairfield, California, United States, 94533
    - North Bay Cancer Center
  - Fremont, California, United States, 94538
    - Kaiser Permanente - Fremont
  - Fremont, California, United States, 94538
    - Valley Medical Oncology
  - Glendale, California, United States, 91204
    - Glendale Memorial Hospital Comprehensive Cancer Center
  - Greenbrae, California, United States, 94904
    - Marin Cancer Institute at Marin General Hospital
  - Greenbrae, California, United States, 94904
    - Sutter Health - Western Division Cancer Research Group
  - Greenbrae, California, United States, 94904
    - California Cancer Care, Incorporated - Greenbrae
  - Hayward, California, United States, 94545
    - Kaiser Permanente Medical Center - Hayward
  - La Jolla, California, United States, 92037
    - Scripps Cancer Center - San Diego
  - Loma Linda, California, United States, 92354
    - Loma Linda University Cancer Institute at Loma Linda University Medical Center
  - Long Beach, California, United States, 90813
    - Pacific Shores Medical Group - Long Beach
  - Los Angeles, California, United States, 90095-1781
    - Jonsson Comprehensive Cancer Center at UCLA
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Larry G Strieff MD Medical Corporation
  - Oakland, California, United States, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, United States, 94609
    - Bay Area Breast Surgeons, Incorporated
  - Oakland, California, United States, 94609
    - Tom K Lee, Incorporated
  - Oakland, California, United States, 94611
    - Kaiser Permanente Medical Center - Oakland
  - Orange, California, United States, 92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  - Pleasanton, California, United States, 94588
    - Valley Care Medical Center
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants - Pleasanton
  - Redding, California, United States, 96001
    - North Valley Breast Clinic
  - Redwood City, California, United States, 94063
    - Kaiser Permanente Medical Center - Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente Medical Center - Richmond
  - Roseville, California, United States, 95661
    - Kaiser Permanente Medical Center - Roseville
  - Roseville, California, United States, 95661
    - Sutter Cancer Center at Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Sutter Cancer center
  - Sacramento, California, United States, 95823
    - South Sacramento Kaiser-Permanente Medical Center
  - Sacramento, California, United States, 95825
    - Kaiser Permanente Medical Center - Sacramento
  - San Diego, California, United States, 92120
    - Kaiser Permanente Medical Office -Vandever Medical Office
  - San Francisco, California, United States, 94115
    - Kaiser Permanente Medical Center - San Francisco Geary Campus
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center - California Campus
  - San Jose, California, United States, 95119
    - Kaiser Permanente Medical Center - Santa Teresa
  - San Pablo, California, United States, 94806
    - Doctors Medical Center - San Pablo Campus
  - San Rafael, California, United States, 94903
    - Kaiser Foundation Hospital - San Rafael
  - Santa Barbara, California, United States, 93105
    - Cancer Center of Santa Barbara
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara Kiely Campus
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente Medical Center - Santa Rosa
  - Santa Rosa, California, United States, 95405
    - CCOP - Santa Rosa Memorial Hospital
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Medical Center - South San Francisco
  - Stanford, California, United States, 94305-5824
    - Stanford Cancer Center
  - Stockton, California, United States, 95210
    - Kaiser Permanente Medical Facility - Stockton
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center
  - Vallejo, California, United States, 94589
    - Kaiser Permanente Medical Center - Vallejo
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente Medical Center - Walnut Creek
- Colorado
  - Aurora, Colorado, United States, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, United States, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, United States, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, United States, 80218
    - St. Joseph Hospital
  - Denver, Colorado, United States, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Englewood, Colorado, United States, 80110
    - Swedish Medical Center
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Front Range Cancer Specialists
  - Grand Junction, Colorado, United States, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80502
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Pueblo, Colorado, United States, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06102-5037
    - Helen and Harry Gray Cancer Center at Hartford Hospital
  - Norwich, Connecticut, United States, 06360
    - Eastern Connecticut Hematology and Oncology Associates
- Delaware
  - Dover, Delaware, United States, 19901
    - Kent General Hospital
  - Lewes, Delaware, United States, 19958
    - Tunnell Cancer Center at Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
  - Washington, District of Columbia, United States, 20010
    - Washington Cancer Institute at Washington Hospital Center
- Florida
  - Clearwater, Florida, United States, 33756
    - Morton Plant Hospital
  - Daytona Beach, Florida, United States, 32115
    - Herbert D. Kerman Regional Oncology Center - Daytona Beach
  - Fort Lauderdale, Florida, United States, 33316
    - Broward General Medical Center Cancer Center
  - Fort Lauderdale, Florida, United States, 33308
    - Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  - Hollywood, Florida, United States, 33021
    - Memorial Cancer Institute at Memorial Regional Hospital
  - Jacksonville, Florida, United States, 32207
    - Baptist Cancer Institute - Jacksonville
  - Jupiter, Florida, United States, 33458
    - Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  - Lakeland, Florida, United States, 33805
    - Lakeland Regional Cancer Center at Lakeland Regional Medical Center
  - Lakeland, Florida, United States, 33805
    - Center for Cancer Care and Research at Watson Clinic, LLP
  - Miami Beach, Florida, United States, 33140
    - CCOP - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32806
    - M.D. Anderson Cancer Center at Orlando
  - Sarasota, Florida, United States, 34236
    - Florida Cancer Specialists - Sarasota Downtown
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, United States, 30342-1611
    - Northside Hospital Cancer Center
  - Atlanta, Georgia, United States, 30342-1701
    - Saint Joseph's Hospital of Atlanta
  - Atlanta, Georgia, United States, 30342
    - CCOP - Atlanta Regional
  - Augusta, Georgia, United States, 30912
    - MBCCOP - Medical College of Georgia Cancer Center
  - Augusta, Georgia, United States, 30901
    - Augusta Oncology Associates - Walton Way
  - Austell, Georgia, United States, 30106
    - WellStar Cobb Hospital
  - Decatur, Georgia, United States, 30033
    - Charles B. Eberhart Cancer Center at DeKalb Medical Center
  - Fort Gordon, Georgia, United States, 30905-5650
    - Dwight David Eisenhower Army Medical Center
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center
  - Lawrenceville, Georgia, United States, 30045
    - Gwinnett Medical Center
  - Marietta, Georgia, United States, 30060
    - Kennestone Cancer Center at Wellstar Kennestone Hospital
  - Riverdale, Georgia, United States, 30274-2600
    - Southern Regional Medical Center
  - Savannah, Georgia, United States, 31403-3089
    - Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  - Savannah, Georgia, United States, 31405
    - Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Medical Center - East
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Hospital at Saint Anthony's Health Center
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, United States, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Graham Hospital
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Chicago, Illinois, United States, 60657
    - Creticos Cancer Center at Advocate Illinois Masonic Medical Center
  - Chicago, Illinois, United States, 60612-3785
    - John H. Stroger, Jr. Hospital of Cook County
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Elgin, Illinois, United States, 60120
    - Sherman Hospital
  - Elk Grove Village, Illinois, United States, 60007
    - Alexian Brothers Radiation Oncology
  - Eureka, Illinois, United States, 61530
    - Eureka Community Hospital
  - Evanston, Illinois, United States, 60201-1781
    - Evanston Northwestern Healthcare - Evanston Hospital
  - Galesburg, Illinois, United States, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, United States, 61401
    - Galesburg Clinic, PC
  - Geneva, Illinois, United States, 60134
    - Delnor Community Hospital - Geneva
  - Havana, Illinois, United States, 62644
    - Mason District Hospital
  - Hinsdale, Illinois, United States, 60521
    - Hinsdale Hematology Oncology Associates
  - Hopedale, Illinois, United States, 61747
    - Hopedale Medical Complex
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Kankakee, Illinois, United States, 60901
    - Provena St. Mary's Regional Cancer Center - Kankakee
  - La Grange, Illinois, United States, 60525
    - La Grange Memorial Hospital
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center
  - Olympia Fields, Illinois, United States, 60461
    - Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
  - Ottawa, Illinois, United States, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, United States, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Park Ridge, Illinois, United States, 60068-1174
    - Advocate Lutheran General Cancer Care Center
  - Pekin, Illinois, United States, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, United States, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, United States, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Rockford, Illinois, United States, 61104-2315
    - Swedish-American Regional Cancer Center
  - Rockford, Illinois, United States, 61108
    - Center for Cancer Care at OSF Saint Anthony Medical Center
  - Spring Valley, Illinois, United States, 61362
    - St. Margaret's Hospital
  - Springfield, Illinois, United States, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Fort Wayne, Indiana, United States, 46815
    - Fort Wayne Medical Oncology and Hematology
  - Indianapolis, Indiana, United States, 46202
    - Methodist Cancer Center at Methodist Hospital
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Lafayette, Indiana, United States, 47904
    - Clarian Arnett Cancer Care
  - Michigan City, Indiana, United States, 46360
    - Saint Anthony Memorial Health Centers
  - Munster, Indiana, United States, 46321
    - Community Hospital
  - Richmond, Indiana, United States, 47374
    - Reid Hospital & Health Care Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, United States, 46617
    - Saint Joseph Regional Medical Center
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, United States, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Davenport, Iowa, United States, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Des Moines, Iowa, United States, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, United States, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50307
    - Mercy Capitol Hospital
  - Iowa City, Iowa, United States, 52242-1002
    - Holden Comprehensive Cancer Center at University of Iowa
  - Mason City, Iowa, United States, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center - Sioux City
  - Waterloo, Iowa, United States, 50702
    - Covenant Cancer Treatment Center
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kansas City, Kansas, United States, 66112
    - Providence Medical Center
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67901
    - Southwest Medical Center
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, PA - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66210
    - Johnson County Radiation Therapy
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - Salina
  - Shawnee Mission, Kansas, United States, 66204
    - Shawnee Mission Medical Center
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Kentucky
  - Ashland, Kentucky, United States, 41101-0151
    - Cancer Resource Center at King's Daughters Medical Center
  - Lexington, Kentucky, United States, 40536-0093
    - Lucille P. Markey Cancer Center at University of Kentucky
  - Louisville, Kentucky, United States, 40207
    - Baptist Hospital East - Louisville
  - Louisville, Kentucky, United States, 40202
    - Louisville Oncology at Norton Cancer Institute - Louisville
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center - Bluebonnet
  - Baton Rouge, Louisiana, United States, 70806
    - Pennington Cancer Center at Baton Rouge General
  - Houma, Louisiana, United States, 70360
    - Terrebonne General Medical Center
  - Metairie, Louisiana, United States, 70006
    - Drs Gurtler Brinz and Russo APMC-Metairie Oncologists
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, United States, 70112
    - MBCCOP - LSU Health Sciences Center
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Cancer Institute at Ochsner Clinic Foundation
  - Shreveport, Louisiana, United States, 71101
    - Christus Schumpert Cancer Treatment Center
- Maryland
  - Baltimore, Maryland, United States, 21202
    - Mercy Medical Center
  - Baltimore, Maryland, United States, 21229
    - St. Agnes Hospital Cancer Center
  - Baltimore, Maryland, United States, 21215
    - Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center Cancer Center
  - Baltimore, Maryland, United States, 21237
    - Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
  - Baltimore, Maryland, United States, 21225
    - Harbor View Cancer Center at Harbor Hospital
  - Bethesda, Maryland, United States, 20814
    - Suburban Hospital
  - Elkton, Maryland, United States, 21921
    - Union Hospital Cancer Program at Union Hospital
  - Largo, Maryland, United States, 20774
    - Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
  - Leonardtown, Maryland, United States, 20650
    - St. Mary's Hospital
  - Lutherville, Maryland, United States, 21093
    - Kaiser Permanente - Towson
  - Rockville, Maryland, United States, 20850
    - Kaiser Permanente Capital Area Medical Group - Shady Grove Facility
  - Salisbury, Maryland, United States, 21801
    - Peninsula Regional Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston University Cancer Research Center
  - Boston, Massachusetts, United States, 02111
    - Tufts-NEMC Cancer Center
  - Concord, Massachusetts, United States, 01742
    - Commonwealth Hematology-Oncology, PC - Concord
  - Dorchester, Massachusetts, United States, 02124
    - Commonwealth Hematology Oncology PC - Dorchester
  - Fall River, Massachusetts, United States, 02721
    - Hudner Oncology Center at Saint Anne's Hospital - Fall River
  - Haverhill, Massachusetts, United States, 01830
    - Commonwealth Hematology-Oncology, PC - Haverhill
  - Lawrence, Massachusetts, United States, 01842
    - Commonwealth Hematology-Oncology, PC - Lawrence
  - Leominster, Massachusetts, United States, 01453
    - Commonwealth Hematology Oncology PC - Leominster
  - Milton, Massachusetts, United States, 02186
    - Commonwealth Hematology Oncology PC - Milton
  - Pittsfield, Massachusetts, United States, 01201
    - Berkshire Hematology Oncology, PC
  - Plymouth, Massachusetts, United States, 02360
    - Jordan Hospital Club Cancer Center
  - Quincy, Massachusetts, United States, 02169
    - Commonwealth Hematology-Oncology, PC - Quincy
  - Stoneham, Massachusetts, United States, 02180
    - Commonwealth Hematology-Oncology, PC - Stoneham
  - Weymouth, Massachusetts, United States, 02190
    - Commonwealth Hematology-Oncology, PC - Weymouth
  - Worcester, Massachusetts, United States, 01605
    - Commonwealth Hematology-Oncology, PC - Worcester
- Michigan
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, United States, 49017
    - Battle Creek Health System Cancer Care Center
  - Bay City, Michigan, United States, 48708
    - Bay Regional Medical Center
  - Big Rapids, Michigan, United States, 49307
    - Mecosta County Medical Center
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, United States, 48532
    - Great Lakes Cancer Institute at McLaren Regional Medical Center
  - Grand Rapids, Michigan, United States, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, United States, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grand Rapids, Michigan, United States, 49506
    - Metro Health Hospital
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Holland, Michigan, United States, 49423
    - Holland Community Hospital
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - West Michigan Cancer Center
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Lansing, Michigan, United States, 48910
    - Breslin Cancer Center at Ingham Regional Medical Center
  - Lapeer, Michigan, United States, 48446
    - Lapeer Regional Hospital
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Marquette, Michigan, United States, 49855
    - Upper Michigan Cancer Center at Marquette General Hospital
  - Muskegon, Michigan, United States, 49442
    - Hackley Hospital
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Oncology Care Associates, PLLC
  - Southfield, Michigan, United States, 48075
    - Providence Cancer Institute at Providence Hospital - Southfield Campus
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - MeritCare Bemidji
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - St. Luke's Hospital Cancer Care Center
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, United States, 56537
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Litchfield, Minnesota, United States, 55355
    - Meeker County Memorial Hospital
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Maplewood, Minnesota, United States, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center - Minneapolis
  - Robbinsdale, Minnesota, United States, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  - Saint Cloud, Minnesota, United States, 56303
    - CentraCare Clinic - River Campus
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital Cancer Care Center
  - Saint Paul, Minnesota, United States, 55102
    - HealthEast Cancer Care at St. Joseph's Hospital
  - Shakopee, Minnesota, United States, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
  - Woodbury, Minnesota, United States, 55125
    - HealthEast Cancer Care at Woodwinds Health Campus
- Mississippi
  - Hattiesburg, Mississippi, United States, 39401
    - Hattiesburg Clinic, PA at Forrest General
  - Hattiesburg, Mississippi, United States, 39402
    - Hematology & Oncology Clinic
  - Pascagoula, Mississippi, United States, 39581
    - Regional Cancer Center at Singing River Hospital
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63701
    - Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  - Chesterfield, Missouri, United States, 63017
    - Saint Luke's Hospital
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center at University of Missouri - Columbia
  - Independence, Missouri, United States, 64050
    - Independence Regional Health Center
  - Joplin, Missouri, United States, 64804
    - St. John's Regional Medical Center
  - Joplin, Missouri, United States, 64804
    - Freeman Cancer Institute at Freeman Health System
  - Kansas City, Missouri, United States, 64131
    - CCOP - Kansas City
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Center - Hospital Hill
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Cancer Institute at Saint Luke's Hospital
  - Kansas City, Missouri, United States, 64114
    - St. Joseph Medical Center
  - Kansas City, Missouri, United States, 64116
    - Parvin Radiation Oncology
  - Kansas City, Missouri, United States, 64114
    - Kansas City Cancer Center at St. Joseph's Medical Mall
  - Kansas City, Missouri, United States, 64154
    - Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, United States, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis, Missouri, United States, 63141
    - Arch Medical Services, Incorporated at Center for Cancer Care and Research
  - Saint Louis, Missouri, United States, 63110
    - Saint Louis University Cancer Center
  - Saint Louis, Missouri, United States, 63109
    - Midwest Hematology Oncology Group, Incorporated
  - Saint Louis, Missouri, United States, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
  - Springfield, Missouri, United States, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, United States, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, United States, 59405
  - Great Falls, Montana, United States, 59405-5309
    - Big Sky Oncology
  - Great Falls, Montana, United States, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Helena, Montana, United States, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, United States, 59801
    - Community Medical Center
  - Missoula, Montana, United States, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, United States, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, United States, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, United States, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68131-2197
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68114
    - Methodist Estabrook Cancer Center
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Nevada Cancer Research Foundation
  - Reno, Nevada, United States, 89502
    - Renown Institute for Cancer at Renown Regional Medical Center
- New Hampshire
  - Exeter, New Hampshire, United States, 03833
    - Center for Cancer Care at Exeter Hospital
- New Jersey
  - Flemington, New Jersey, United States, 08822
    - Hunterdon Regional Cancer Center at Hunterdon Medical Center
  - Hamilton, New Jersey, United States, 08690
    - Cancer Institute of New Jersey at Hamilton
  - Marlton, New Jersey, United States, 08053
    - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  - Montclair, New Jersey, United States, 07042
    - Mountainside Hospital Cancer Center
  - New Brunswick, New Jersey, United States, 08903
    - Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  - New Brunswick, New Jersey, United States, 08903
    - Saint Peter's University Hospital
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Phillipsburg, New Jersey, United States, 08865
    - Warren Hospital
  - Vineland, New Jersey, United States, 08360
    - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
  - Voorhees, New Jersey, United States, 08043
    - Cancer Institute of New Jersey at Cooper - Voorhees
  - Voorhees, New Jersey, United States, 08043
    - Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- New Mexico
  - Albuquerque, New Mexico, United States, 87131-5636
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87106
    - Hematology Oncology Associates, PC
  - Albuquerque, New Mexico, United States, 87108
    - Lovelace Medical Center - Gibson
  - Santa Fe, New Mexico, United States, 87505
    - New Mexico Cancer Care Associates
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology, PC at Albany Regional Cancer Care
  - Albany, New York, United States, 12208
    - New York Oncology Hematology, PC at Albany Medical Center
  - Amsterdam, New York, United States, 12010
    - Amsterdam Community Cancer Program
  - Bronx, New York, United States, 10461
    - Albert Einstein Cancer Center at Albert Einstein College of Medicine
  - Bronx, New York, United States, 10466
    - Our Lady of Mercy Medical Center Comprehensive Cancer Center
  - Clifton Springs, New York, United States, 14432
    - Finger Lakes Hematology and Oncology
  - East Syracuse, New York, United States, 13057
    - CCOP - Hematology-Oncology Associates of Central New York
  - Glens Falls, New York, United States, 12801
    - Charles R. Wood Cancer Center at Glens Falls Hospital
  - Hudson, New York, United States, 12534
    - New York Oncology Hematology, PC - Hudson
  - Jamaica, New York, United States, 11432
    - Queens Cancer Center of Queens Hospital
  - Latham, New York, United States, 12110
    - New York Oncology Hematology, PC - Latham
  - Manhasset, New York, United States, 11030
    - CCOP - North Shore University Hospital
  - Manhasset, New York, United States, 11030
    - Don Monti Comprehensive Cancer Center at North Shore University Hospital
  - New Hyde Park, New York, United States, 11042
    - Long Island Jewish Medical Center
  - Rexford, New York, United States, 12148
    - Riverview Cancer Care Medical Associates, PC
  - Troy, New York, United States, 12180
    - Samaritan Hospital at Northeast Health
- North Carolina
  - Asheboro, North Carolina, United States, 27203-5400
    - Randolph Hospital
  - Asheville, North Carolina, United States, 28801
    - Mission Hospitals - Memorial Campus
  - Burlington, North Carolina, United States, 27216
    - Alamance Cancer Center at Alamance Regional Medical Center
  - Charlotte, North Carolina, United States, 28232-2861
    - Blumenthal Cancer Center at Carolinas Medical Center
  - Eden, North Carolina, United States, 27288
    - John Smith, Jr. - Dalton McMichael Cancer Center at Morehead Memorial Hospital
  - Fayetteville, North Carolina, United States, 28302-2000
    - Cape Fear Valley Medical Center Cancer Center
  - Gastonia, North Carolina, United States, 28053
    - CaroMont Cancer Center at Gaston Memorial Hospital
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital, Incorporated
  - Greensboro, North Carolina, United States, 27403-1198
    - Moses Cone Regional Cancer Center at Wesley Long Community Hospital
  - Greenville, North Carolina, United States, 27835-6028
    - Leo W. Jenkins Cancer Center at ECU Medical School
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Cancer Center
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
  - Washington, North Carolina, United States, 27889
    - Marion L. Shepard Cancer Center at Beaufort County Hospital
  - Winston-Salem, North Carolina, United States, 27157-1096
    - Wake Forest University Comprehensive Cancer Center
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, United States, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, United States, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, United States, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, United States, 58122
    - MeritCare Broadway
- Ohio
  - Akron, Ohio, United States, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Akron, Ohio, United States, 44309-2090
    - Summa Center for Cancer Care at Akron City Hospital
  - Bellefontaine, Ohio, United States, 43311
    - Mary Rutan Hospital
  - Canton, Ohio, United States, 44710-1799
    - Aultman Cancer Center at Aultman Hospital
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45267
    - Charles M. Barrett Cancer Center at University Hospital
  - Cincinnati, Ohio, United States, 45219
    - Christ Hospital Cancer Center
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care, Incorporated - Blue Ash
  - Cleveland, Ohio, United States, 44106-5065
    - Case Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43210-1240
    - Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Dayton, Ohio, United States, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45429
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Middletown Regional Hospital
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45801
    - St. Rita's Medical Center
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, United States, 45504
    - Mercy Medical Center
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Wilmington, Ohio, United States, 45177
    - Clinton Memorial Hospital
  - Wooster, Ohio, United States, 44691
    - Cancer Treatment Center
  - Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
    - United States Air Force Medical Center - Wright-Patterson
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Youngstown, Ohio, United States, 44501
    - Tod Children's Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cleo Craig Cancer Research Clinic
  - Oklahoma City, Oklahoma, United States, 73104
    - Oklahoma University Cancer Institute
  - Oklahoma City, Oklahoma, United States, 73120
    - Cancer Care Associates - Mercy Campus
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
  - Tulsa, Oklahoma, United States, 74104
    - LaFortune Cancer Center at St. John Medical Center
- Oregon
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Portland, Oregon, United States, 97216
    - Adventist Medical Center
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital & Comprehensive Cancer Center
  - Portland, Oregon, United States, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, United States, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, United States, 97227
    - Legacy Emanuel Hospital and Health Center and Children's Hospital
  - Portland, Oregon, United States, 97232
    - Kaiser Permanente Health Care - Portland
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Rosenfeld Cancer Center at Abington Memorial Hospital
  - Allentown, Pennsylvania, United States, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - DuBois, Pennsylvania, United States, 15801
    - Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Dale and Frances Hughes Cancer Center at Pocono Medical Center
  - Easton, Pennsylvania, United States, 18042
    - Easton Regional Cancer Center at Easton Hospital
  - Ephrata, Pennsylvania, United States, 17522
    - Ephrata Cancer Center at Ephrata Community Hospital
  - Erie, Pennsylvania, United States, 16505
    - Regional Cancer Center - Erie
  - Erie, Pennsylvania, United States, 16544
    - Saint Vincent Health Center
  - Harrisburg, Pennsylvania, United States, 17110-2098
    - PinnacleHealth Regional Cancer Center at Polyclinic Hospital
  - Kittanning, Pennsylvania, United States, 16201
    - Richard G. Laube Cancer Center at ACMH
  - Media, Pennsylvania, United States, 19063
    - Riddle Memorial Hospital Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104-4283
    - Abramson Cancer Center of The University of Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107-5541
    - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  - Philadelphia, Pennsylvania, United States, 19114
    - Frankford Hospital Cancer Center - Torresdale Campus
  - Pittsburgh, Pennsylvania, United States, 15232
    - UPMC Cancer Centers
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny Cancer Center at Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15224-1791
    - Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  - Pottstown, Pennsylvania, United States, 19464
    - Pottstown Memorial Regional Cancer Center
  - Reading, Pennsylvania, United States, 19612-6052
    - McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
  - Sayre, Pennsylvania, United States, 18840
    - Guthrie Cancer Center at Guthrie Clinic Sayre
  - Scranton, Pennsylvania, United States, 18501
    - Mercy Hospital Cancer Center - Scranton
  - Scranton, Pennsylvania, United States, 18508
    - Hematology and Oncology Associates of Northeastern Pennsylvania
  - State College, Pennsylvania, United States, 16803
    - Mount Nittany Medical Center
  - Upland, Pennsylvania, United States, 19013
    - Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
  - York, Pennsylvania, United States, 17405
    - York Cancer Center at Apple Hill Medical Center
- Rhode Island
  - Cranston, Rhode Island, United States, 02920
    - Hematology and Oncology Associates of Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Women and Infants Hospital of Rhode Island
  - Warwick, Rhode Island, United States, 02886
    - Kent County Memorial Hospital
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Cancer Center
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Aberdeen, South Dakota, United States, 57401
    - Oncology Services of Aberdeen
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, United States, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Tennessee
  - Knoxville, Tennessee, United States, 37920-6999
    - U.T. Medical Center Cancer Institute
- Texas
  - Austin, Texas, United States, 78705
    - Texas Oncology - Midtown Austin
  - Austin, Texas, United States, 78731
    - Texas Oncology, PA at Texas Oncology Cancer Center - Central
  - Austin, Texas, United States, 78745
    - Texas Oncology, PA at South Austin Cancer Center
  - Bryan, Texas, United States, 77802
    - St. Joseph Regional Cancer Center
  - Houston, Texas, United States, 77030
    - Baylor University Medical Center - Houston
  - Lubbock, Texas, United States, 79410-1894
    - Joe Arrington Cancer Research and Treatment Center
  - Round Rock, Texas, United States, 78681
    - Texas Oncology, PA at Texas Cancer Center Round Rock
  - San Antonio, Texas, United States, 78229-3900
    - University of Texas Health Science Center at San Antonio
  - Temple, Texas, United States, 76508
    - CCOP - Scott and White Hospital
- Utah
  - American Fork, Utah, United States, 84003
    - American Fork Hospital
  - Cedar City, Utah, United States, 84720
    - Sandra L. Maxwell Cancer Center
  - Murray, Utah, United States, 84157
    - Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  - Ogden, Utah, United States, 84403
    - Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  - Provo, Utah, United States, 84604
    - Utah Valley Regional Medical Center - Provo
  - Saint George, Utah, United States, 84770
    - Dixie Regional Medical Center - East Campus
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute at University of Utah
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists at UCS Cancer Center
- Vermont
  - Bennington, Vermont, United States, 05201
    - Green Mountain Oncology Group
- Virginia
  - Fairfax, Virginia, United States, 22033
    - Kaiser Permanente Medical Center - Fair Oaks
  - Hampton, Virginia, United States, 23666
    - Virginia Oncology Associates - Hampton
  - Lynchburg, Virginia, United States, 24501
    - Lynchburg Hematology-Oncology Clinic
  - Richmond, Virginia, United States, 23298-0037
    - Virginia Commonwealth University Massey Cancer Center
  - Richmond, Virginia, United States, 23230
    - Virginia Cancer Institute - West End
  - Roanoke, Virginia, United States, 24014
    - Carilion Cancer Center of Western Virginia
- Washington
  - Bellevue, Washington, United States, 98004
    - Overlake Cancer Center at Overlake Hospital Medical Center
  - Bellingham, Washington, United States, 98225
    - St. Joseph Cancer Center
  - Bremerton, Washington, United States, 98310
    - Olympic Hematology and Oncology
  - Federal Way, Washington, United States, 98003
    - St. Francis Hospital
  - Port Angeles, Washington, United States, 98362
    - Olympic Medical Center
  - Puyallup, Washington, United States, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, United States, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, United States, 98104
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, United States, 98112
    - Group Health Central Hospital
  - Seattle, Washington, United States, 98122-4307
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Spokane, Washington, United States, 99204-2967
    - Rockwood Clinic Cancer Treatment Center
  - Spokane, Washington, United States, 99204
    - Providence Cancer Center at Sacred Heart Medical Center
  - Spokane, Washington, United States, 99207
    - Providence Cancer Center at Holy Family Hospital
  - Spokane, Washington, United States, 99218
    - Cancer Care Northwest - North
  - Tacoma, Washington, United States, 98405-3004
    - Franciscan Cancer Center at St. Joseph Medical Center
  - Tacoma, Washington, United States, 98405
    - Allenmore Hospital
  - Tacoma, Washington, United States, 98405
    - CCOP - Northwest
  - Tacoma, Washington, United States, 98499
    - St. Clare Hospital
  - Vancouver, Washington, United States, 98668
    - Southwest Washington Medical Center Cancer Center
  - Walla Walla, Washington, United States, 99362
    - St. Mary Regional Cancer Center at St. Mary Medical Center
  - Wenatchee, Washington, United States, 98801-2028
    - Wenatchee Valley Medical Center
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
  - Huntington, West Virginia, United States, 25702
    - St. Mary's Regional Cancer Center at St. Mary's Medical Center
  - Morgantown, West Virginia, United States, 26506
    - Mary Babb Randolph Cancer Center at West Virginia University Hospitals
  - Parkersburg, West Virginia, United States, 26102
    - Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
  - Princeton, West Virginia, United States, 24740
    - Princeton Community Hospital
- Wisconsin
  - Eau Claire, Wisconsin, United States, 54701
    - Center for Cancer Treatment & Prevention at Sacred Heart Hospital
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - Elkhorn, Wisconsin, United States, 53121
    - Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
  - Fond Du Lac, Wisconsin, United States, 54935
    - Central Wisconsin Cancer Program at Agnesian HealthCare
  - Glendale, Wisconsin, United States, 53212-1038
    - Oncology Alliance, SC - Milwaukee - East
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Madison, Wisconsin, United States, 53717
    - Dean Medical Center - Madison
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Saint Joseph's Hospital
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic - Marshfield Center
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin Cancer Center
  - Milwaukee, Wisconsin, United States, 53201-0342
    - Aurora Sinai Medical Center
  - Milwaukee, Wisconsin, United States, 53215
    - Medical Consultants, Limited
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic - Lakeland Center
  - Rhinelander, Wisconsin, United States, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic - Indianhead Center
  - Stevens Point, Wisconsin, United States, 54481
    - Saint Michael's Hospital Cancer Center
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic - Two Rivers
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic - Wausau Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / 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-FU 5-fluorouracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival Time Frame: 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	9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Time Frame: 9 years	Percentage of patients alive	9 years
Adverse Events Time Frame: 9 years	Percentage of patients with at least one grade 2 or higher adverse event reported	9 years
Quality of Life-Functional Assessment of Cancer Therapy Time Frame: 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.	12 months
Post Chemotherapy Amenorrhea Time Frame: 18 months	Percent with post chemotherapy amenorrhea	18 months
Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation Time Frame: 12 months	Change in LVEF from randomization to 12 months	12 months
HER-2 and Topo II Gene Amplification Time Frame: 6 years		6 years
Recurrence-free Interval Time Frame: 9 years	Percentage of patients with local-regional recurrence or distant recurrence	9 years
Distant Recurrence-free Interval Time Frame: 9 years	Percentage of patients with distant recurrence	9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NSABP Foundation Inc

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 8, 2004

First Submitted That Met QC Criteria

July 9, 2004

First Posted (Estimate)

July 12, 2004

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NSABP B-36
U10CA012027 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Breast Cancer

Clinical Trials on cyclophosphamide

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