S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer

April 11, 2024 updated by: SWOG Cancer Research Network

Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer.

PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.

Study Overview

Status

Active, not recruiting

Conditions

Breast Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

Compare the disease-free survival of patients with node-positive or high-risk node-negative breast cancer treated with 2 different schedules of adjuvant doxorubicin, cyclophosphamide, and paclitaxel.
Compare the overall survival of patients treated with these regimens.
Compare the toxic effects of these regimens in these patients.
Correlate outcome with putative prognostic markers in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms (arms V and VI) (arms I-IV closed 11/10/10).

Arm I: (closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Arm II: (closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses.

Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

Arm III: (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

Arm IV: (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II.

Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

Arm V: Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Arm VI: Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim as in arm V.

Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

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

In all arms patients with HER2/neu-positive tumors also receive trastuzumab (Herceptin®) weekly or every 3 weeks beginning concurrently with paclitaxel OR 3 months after the last dose of paclitaxel and continuing for up to 52 weeks.

In all arms, patients with estrogen-receptor or progesterone-receptor positive tumors receive hormonal therapy beginning within 28 days of the completion of adjuvant chemotherapy or radiotherapy (if given).

After finishing study treatment patients are followed up every 6 months for 5 years and then once a year for up to 15 years.

PROJECTED ACCRUAL: A total of 3,250 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

3294

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
- Ontario
  - Thunder Bay, Ontario, Canada, P7B 6V4
    - Cancer Care Program at Thunder Bay Regional Health Sciences
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
Puerto Rico
- - San Juan, Puerto Rico, 00936
    - San Juan City Hospital
United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Regional Medical Center
  - Birmingham, Alabama, United States, 35294
    - Uab Comprehensive Cancer Center
  - Mobile, Alabama, United States, 36608
    - Providence Cancer Center at Providence Hospital
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Providence Cancer Center
- Arizona
  - Scottsdale, Arizona, United States, 85259-5499
    - Mayo Clinic Scottsdale
  - Tucson, Arizona, United States, 85724-5024
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Fort Smith, Arkansas, United States, 72903
    - Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
  - 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
  - Fremont, California, United States, 94538
    - Valley Medical Oncology
  - Fresno, California, United States, 93720
    - California Cancer Center - Woodward Park Office
  - Long Beach, California, United States, 90806
    - Todd Cancer Institute at Long Beach Memorial Medical Center
  - Los Angeles, California, United States, 90089-9181
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Marysville, California, United States, 95901
    - Tibotec Therapeutics - Division of Ortho Biotech Products, LP
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Mountain View, California, United States, 94040
    - El Camino Hospital Cancer Center
  - Novato, California, United States, 94945
    - Sutter Health - Western Division Cancer Research Group
  - 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
  - Orange, California, United States, 92868
    - St. Joseph Hospital Regional Cancer Center - Orange
  - Palm Springs, California, United States, 92262
    - Desert Regional Medical Center Comprehensive Cancer Center
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants - Pleasanton
  - Roseville, California, United States, 95661
    - Sutter Cancer Center at Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Sutter Cancer Center
  - Sacramento, California, United States, 95817
    - University of California Davis Cancer Center
  - San Francisco, California, United States, 94115
    - UCSF Helen Diller Family Comprehensive Cancer Center
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center - California Campus
  - San Pablo, California, United States, 94806
    - Doctors Medical Center - San Pablo Campus
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center
- Colorado
  - Alamosa, Colorado, United States, 81101
    - San Luis Valley Regional Medical Center
  - Aurora, Colorado, United States, 80045
    - University of Colorado Cancer Center at UC Health Sciences Center
  - Colorado Springs, Colorado, United States, 80909
    - Memorial Hospital Cancer Center - Colorado Springs
  - Denver, Colorado, United States, 80220
    - Veterans Affairs Medical Center - Denver
  - Denver, Colorado, United States, 80204
    - Denver Health Medical Center
  - Edwards, Colorado, United States, 81632
    - Shaw Regional Cancer Center
  - Glenwood Springs, Colorado, United States, 81601
    - Valley View Hospital Cancer Center
  - Montrose, Colorado, United States, 81401
    - Montrose Memorial Hospital Cancer Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  - New Haven, Connecticut, United States, 06520-8028
    - Yale Cancer Center
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Washington Cancer Institute at Washington Hospital Center
- Florida
  - Daytona Beach, Florida, United States, 32114
    - Herbert D. Kerman Regional Oncology Center - Daytona Beach
  - Daytona Beach, Florida, United States, 32117
    - Florida Hospital Memorial Medical Center
  - Fort Lauderdale, Florida, United States, 33308
    - Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic - Jacksonville
  - Jupiter, Florida, United States, 33458
    - Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  - Miami Beach, Florida, United States, 33140
    - CCOP - Mount Sinai Medical Center
- 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
  - Austell, Georgia, United States, 30106
    - WellStar Cobb Hospital
  - Columbus, Georgia, United States, 31904
    - John B. Amos Cancer Center
  - Decatur, Georgia, United States, 30033
    - Charles B. Eberhart Cancer Center at DeKalb Medical Center
  - Fayetteville, Georgia, United States, 30214
    - Piedmont Fayette Hospital
  - Fort Gordon, Georgia, United States, 30905-5650
    - Dwight David Eisenhower Army 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
  - Rome, Georgia, United States, 30165
    - Harbin Clinic Cancer Center - Medical Oncology
  - Valdosta, Georgia, United States, 31603
    - Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Kapiolani Medical Center at Pali Momi
  - 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
    - OnCare Hawaii, Incorporated - Lusitana
  - 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
  - Honolulu, Hawaii, United States, 96817
    - OnCare Hawaii, Incorporated - Kuakini
  - Honolulu, Hawaii, United States, 96859
    - Tripler Army Medical Center
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Kauai Medical Clinic
  - Wailuku, Hawaii, United States, 96793
    - Maui Memorial Medical Center
  - Wailuku, Hawaii, United States, 96793
    - Pacific Cancer Institute - Maui
- Idaho
  - Boise, Idaho, United States, 83712
    - Mountain States Tumor Institute at St. Luke's Regional Medical Center
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Cancer Center - Coeur d'Alene
- 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
    - Illinois CancerCare - Bloomington
  - Bloomington, Illinois, United States, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare - Canton
  - Canton, Illinois, United States, 61520
    - Graham Hospital
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare - Carthage
  - Chicago, Illinois, United States, 60611-3013
    - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  - Chicago, Illinois, United States, 60611
    - Hematology and Oncology Associates
  - Chicago, Illinois, United States, 60657
    - Saint Joseph Hospital
  - Chicago, Illinois, United States, 60631
    - Resurrection Medical Center
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Elgin, Illinois, United States, 60123
    - Sherman Hospital
  - Elmhurst, Illinois, United States, 60126
    - Elmhurst Memorial Hospital
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare - Eureka
  - Eureka, Illinois, United States, 61530
    - Eureka Community Hospital
  - Evanston, Illinois, United States, 60202
    - St. Francis Hospital
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare - Galesburg
  - Galesburg, Illinois, United States, 61401
    - Galesburg Clinic, PC
  - Harvey, Illinois, United States, 60426
    - Ingalls Cancer Care Center at Ingalls Memorial Hospital
  - Havana, Illinois, United States, 62644
    - Mason District Hospital
  - Havana, Illinois, United States, 62644
    - Illinois CancerCare - Havana
  - Highland Park, Illinois, United States, 60035
    - Kellogg Cancer Care Center
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Kankakee, Illinois, United States, 60901
    - Provena St. Mary's Regional Cancer Center - Kankakee
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare - Kewanee Clinic
  - Libertyville, Illinois, United States, 60048
    - North Shore Oncology and Hematology Associates, Limited - Libertyville
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare - Macomb
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Maywood, Illinois, United States, 60153
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare - Monmouth
  - Monmouth, Illinois, United States, 61462
    - OSF Holy Family Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Naperville, Illinois, United States, 60540
    - Edward Hospital Cancer Center
  - Naperville, Illinois, United States, 60540
    - Hematology Oncology Consultants - Naperville
  - Niles, Illinois, United States, 60714
    - Cancer Care and Hematology Specialists of Chicagoland - Niles
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center
  - Normal, Illinois, United States, 61761
    - Illinois CancerCare - Community Cancer Center
  - Ottawa, Illinois, United States, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, United States, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, United States, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Pekin, Illinois, United States, 61603
    - Illinois CancerCare - Pekin
  - 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 CancerCare - Peru
  - Peru, Illinois, United States, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare - Princeton
  - Rockford, Illinois, United States, 61104-2315
    - Swedish-American Regional Cancer Center
  - Skokie, Illinois, United States, 60076
    - Hematology Oncology Associates - Skokie
  - Spring Valley, Illinois, United States, 61362
    - Illinois CancerCare - Spring Valley
  - Springfield, Illinois, United States, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
  - Warrenville, Illinois, United States, 60555
    - Central Dupage 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
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic, LLC
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology-Oncology, PC - Elkhart
  - Fort Wayne, Indiana, United States, 46845
    - Fort Wayne Medical Oncology and Hematology
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Michigan City, Indiana, United States, 46360
    - Saint Anthony Memorial Health Centers
  - Mishawaka, Indiana, United States, 46545-1470
    - Michiana Hematology-Oncology, PC - South Bend
  - Mishawaka, Indiana, United States, 46545-1470
    - Saint Joseph Regional Medical Center
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC - Plymouth
  - 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
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC - La Porte
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, United States, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates - West Des Moines
  - Council Bluffs, Iowa, United States, 51503
    - Heartland Oncology and Hematology
  - 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
  - Mason City, Iowa, United States, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Ottumwa, Iowa, United States, 52501
    - McCreery Cancer Center at Ottumwa Regional
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical 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
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Hays, Kansas, United States, 67601
    - Hays Medical Center
  - Hutchinson, Kansas, United States, 67502
    - Hutchinson Hospital Corporation
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kansas City, Kansas, United States, 66160-7357
    - Kansas Masonic Cancer Research Institute at the University of Kansas 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
    - Cancer Center of Kansas, PA - Liberal
  - 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, 66213
    - Saint Luke's Hospital - South
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pittsburg, Kansas, United States, 66762
    - Mount Carmel Regional Cancer Center
  - Prairie Village, Kansas, United States, 66208
    - CCOP - Kansas City
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas, PA - Salina
  - Topeka, Kansas, United States, 66606
    - Cotton-O'Neil Cancer Center
  - Topeka, Kansas, United States, 66606
    - St. Francis Comprehensive Cancer 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
- Louisiana
  - Alexandria, Louisiana, United States, 71315-3198
    - Tulane Cancer Center Office of Clinical Research
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center - Bluebonnet
  - Covington, Louisiana, United States, 70433
    - Ochsner Health Center - Covington
  - Monroe, Louisiana, United States, 71210
    - Louisiana State University Health Sciences Center - Monroe
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Cancer Institute at Ochsner Clinic Foundation
  - New Orleans, Louisiana, United States, 70115
    - New Orleans Cancer Institute at Memorial Medical Center
  - Shreveport, Louisiana, United States, 71130-3932
    - Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  - Shreveport, Louisiana, United States, 71101
    - Christus Schumpert Cancer Treatment Center
- Maryland
  - Baltimore, Maryland, United States, 21229
    - St. Agnes Hospital Cancer Center
  - Baltimore, Maryland, United States, 21215
    - Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  - Cumberland, Maryland, United States, 21502
    - Regional Cancer Center at Western Maryland Health System - Sacred Heart Campus
  - Salisbury, Maryland, United States, 21801
    - Peninsula Regional Medical Center
- Massachusetts
  - Brighton, Massachusetts, United States, 02135-2997
    - Caritas St. Elizabeth's Medical Center
  - Gloucester, Massachusetts, United States, 01930
    - Addison Gilbert Hospital
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, United States, 48109-0942
    - University of Michigan Comprehensive Cancer Center
  - 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, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - 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
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - 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
  - Midland, Michigan, United States, 48670
    - MidMichigan Medical Center - Midland
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital - Monroe
  - Mount Clemens, Michigan, United States, 48043
    - Clemens Regional Medical Center
  - Muskegon, Michigan, United States, 49443
    - Mercy General Health Partners
  - Niles, Michigan, United States, 49120
    - Michiana Hematology Oncology PC - Niles
  - Petoskey, Michigan, United States, 49770
    - Northern Michigan 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
    - Lakeside Cancer Specialists, PLLC
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - 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
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
- Minnesota
  - Alexandria, Minnesota, United States, 56308
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - 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
    - Humphrey Cancer Center at North Memorial Outpatient Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, United States, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center
  - 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
  - Shakopee, Minnesota, United States, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Mississippi
  - Keesler Air Force Base, Mississippi, United States, 39534
    - Keesler Air Force Base Medical Center
  - 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, 63703
    - Southeast Cancer Center
  - Jefferson City, Missouri, United States, 65109
    - Goldschmidt Cancer 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, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - 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, 64118
    - Heartland Hematology Oncology Associates, Incorporated
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Liberty Hospital
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Joseph, Missouri, United States, 64507
    - Saint Joseph Oncology, Incorporated
  - 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, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  - 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
  - Saint Louis, Missouri, United States, 63141
    - Comprehensive Cancer Care, PC
  - 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
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Billings, Montana, United States, 59102
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - 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, 59405-5309
    - Big Sky Oncology
  - Great Falls, Montana, United States, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Havre, Montana, United States, 59501
    - Northern Montana Hospital
  - 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, 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, 68130
    - Lakeside Hospital
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
  - Hooksett, New Hampshire, United States, 03106
    - New Hampshire Oncology - Hematology, PA - Hooksett
  - Lebanon, New Hampshire, United States, 03756-0002
    - Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- New Jersey
  - Englewood, New Jersey, United States, 07631
    - Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
  - Hackensack, New Jersey, United States, 07601
    - CCOP - Northern New Jersey
  - Livingston, New Jersey, United States, 07039
    - St. Barnabas Medical Center Cancer Center
  - Newark, New Jersey, United States, 07103
    - UMDNJ University Hospital
  - Somerville, New Jersey, United States, 08876
    - Somerset Medical Center
  - Summit, New Jersey, United States, 07902
    - Overlook Hospital
  - Vineland, New Jersey, United States, 08360
    - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- 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, 87110
    - Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
  - Las Cruces, New Mexico, United States, 88011
    - University of New Mexico Cancer Center - South
- New York
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute
  - East Syracuse, New York, United States, 13057
    - CCOP - Hematology-Oncology Associates of Central New York
  - New York, New York, United States, 10021
    - New York Weill Cornell Cancer Center at Cornell University
  - New York, New York, United States, 10025
    - St. Luke's - Roosevelt Hospital Center - St.Luke's Division
  - New York, New York, United States, 10003-3803
    - Beth Israel Medical Center - Petrie Division
  - Nyack, New York, United States, 10960-1998
    - Union State Bank Cancer Center at Nyack Hospital
  - Rochester, New York, United States, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Rochester, New York, United States, 14620
    - Highland Hospital of Rochester
  - Rochester, New York, United States, 14621
    - Lipson Cancer and Blood Center at Rochester General Hospital
- North Carolina
  - Asheville, North Carolina, United States, 28816
    - Hope A Women's Cancer Center
  - Chapel Hill, North Carolina, United States, 27599-7295
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Concord, North Carolina, United States, 28025
    - Batte Cancer Center at Northeast Medical Center
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital, Incorporated
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists
- 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
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center at Altru Hospital
- 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
  - Barberton, Ohio, United States, 44203
    - Barberton Citizens Hospital
  - Beachwood, Ohio, United States, 44122
    - Cleveland Clinic Beachwood Family Health and Surgery Center
  - Bellefontaine, Ohio, United States, 43311
    - Mary Rutan Hospital
  - Bowling Green, Ohio, United States, 43402
    - Wood County Oncology Center
  - Canton, Ohio, United States, 44708
    - Mercy Cancer Center at Mercy Medical Center
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, United States, 45220
    - Good Samaritan Hospital Cancer Treatment Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, United States, 44106-5065
    - Case Comprehensive Cancer Center
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center at Fairview Hospital
  - 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, 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, 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, 45420
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Community Cancer Center
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, United States, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Independence, Ohio, United States, 44131
    - Cleveland Clinic Cancer Center
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Lima, Ohio, United States, 45801
    - St. Rita's Medical Center
  - Mansfield, Ohio, United States, 44903
    - MedCentral - Mansfield Hospital
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537-1839
    - Northwest Ohio Oncology Center
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Cancer Center at Hillcrest Hospital
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Norwalk, Ohio, United States, 44857
    - Fisher-Titus Medical Center
  - Oregon, Ohio, United States, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic - Oregon
  - Parma, Ohio, United States, 44129
    - Parma Community General Hospital
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Strongsville, Ohio, United States, 44136
    - Cleveland Clinic Foundation - Strongsville
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, United States, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, United States, 43623
    - St. Anne Mercy Hospital
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic - Wooster
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cleo Craig Cancer Research Clinic
  - Norman, Oklahoma, United States, 73071
    - Cancer Care Associates - Norman
  - Oklahoma City, Oklahoma, United States, 73120
    - Cancer Care Associates - Mercy Campus
  - Oklahoma City, Oklahoma, United States, 73120
    - Cancer Care Associates at Troy and Dollie Smith Cancer Center
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Willamette Falls Hospital
  - Portland, Oregon, United States, 97239-3098
    - Knight Cancer Institute At Oregon Health and Science University
  - 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
- Pennsylvania
  - Butler, Pennsylvania, United States, 16001
    - Butler Memorial Hospital
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Dale and Frances Hughes Cancer Center at Pocono Medical Center
  - Harrisburg, Pennsylvania, United States, 17110-2098
    - PinnacleHealth Regional Cancer Center at Polyclinic Hospital
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
  - Lewistown, Pennsylvania, United States, 17044
    - Lewistown Hospital
  - Philadelphia, Pennsylvania, United States, 19111-2497
    - Fox Chase Cancer Center - Philadelphia
  - Philadelphia, Pennsylvania, United States, 19107-5541
    - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  - Pottstown, Pennsylvania, United States, 19464
    - Pottstown Memorial Regional Cancer 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
  - Williamsport, Pennsylvania, United States, 17701
    - Susquehanna Cancer Center at Divine Providence Hospital
- South Carolina
  - Columbia, South Carolina, United States, 29210
    - South Carolina Oncology Associates, PA
  - Easley, South Carolina, United States, 29640
    - Cancer Centers of the Carolinas - Easley
  - Florence, South Carolina, United States, 29501
    - McLeod Regional Medical Center
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Greenville, South Carolina, United States, 29605
    - Greenville Hospital Cancer Center
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Faris Road
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Grove Commons
  - Greenwood, South Carolina, United States, 29646
    - Self Regional Cancer Center at Self Regional Medical Center
  - Greer, South Carolina, United States, 29650
    - Cancer Centers of the Carolinas - Greer Medical Oncology
  - Seneca, South Carolina, United States, 29672
    - Cancer Centers of the Carolinas - Seneca
  - Spartanburg, South Carolina, United States, 29307
    - Cancer Centers of the Carolinas - Spartanburg
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
  - 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
  - Memphis, Tennessee, United States, 38104
    - University of Tennessee Cancer Institute - Memphis
  - Nashville, Tennessee, United States, 37208-3599
    - MBCCOP - Meharry Medical College - Nashville
- Texas
  - El Paso, Texas, United States, 79905
    - Texas Tech University Health Sciences Center School of Medicine - El Paso
  - Galveston, Texas, United States, 77555-0361
    - University of Texas Medical Branch
  - Lubbock, Texas, United States, 79415-3364
    - UMC Southwest Cancer and Research Center
  - San Antonio, Texas, United States, 78209
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - San Antonio, Texas, United States, 78229-3900
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, United States, 78229
    - University Hospital - San Antonio
- Utah
  - American Fork, Utah, United States, 84003
    - American Fork Hospital
  - Cedar City, Utah, United States, 84720
    - Sandra L. Maxwell Cancer Center
  - Logan, Utah, United States, 84321
    - Logan Regional Hospital
  - 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, 84106
    - Utah Cancer Specialists at UCS Cancer Center
- Vermont
  - Bennington, Vermont, United States, 05201
    - Green Mountain Oncology Group
- Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology, Incorporated
  - Fredericksburg, Virginia, United States, 22408
    - Hematology-Oncology Associates of Fredericksburg, Incorporated
- Washington
  - Anacortes, Washington, United States, 98221
    - Island Hospital Cancer Care Center at Island Hospital
  - Bellingham, Washington, United States, 98225
    - St. Joseph Cancer Center
  - Bremerton, Washington, United States, 98310
    - Olympic Hematology and Oncology
  - Burien, Washington, United States, 98166
    - Highline Medical Center Cancer Center
  - Centralia, Washington, United States, 98531-9027
    - Providence Centralia Hospital
  - Federal Way, Washington, United States, 98003
    - St. Francis Hospital
  - Kennewick, Washington, United States, 99336
    - Columbia Basin Hematology
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital Cancer Care Center
  - Olympia, Washington, United States, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Poulsbo, Washington, United States, 98370
    - Harrison Poulsbo Hematology and Onocology
  - Puyallup, Washington, United States, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98104
    - Minor and James Medical, PLLC
  - 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
  - Seattle, Washington, United States, 98195
    - University Cancer Center at University of Washington Medical Center
  - Sedro-Woolley, Washington, United States, 98284
    - North Puget Oncology at United General Hospital
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, United States, 99218
    - Evergreen Hematology and Oncology, PS
  - Spokane, Washington, United States, 99204
    - Providence Cancer Center at Sacred Heart Medical Center
  - 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, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
  - Tacoma, Washington, United States, 98499
    - St. Clare Hospital
  - Tacoma, Washington, United States, 98431
    - Madigan Army Medical Center - Tacoma
  - Vancouver, Washington, United States, 98684
    - Northwest Cancer Specialists at Vancouver Cancer Center
  - Vancouver, Washington, United States, 98664
    - Southwest Washington Medical Center Cancer Center
  - Wenatchee, Washington, United States, 98801-2028
    - Wenatchee Valley Medical Center
  - Yakima, Washington, United States, 98902
    - North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia
  - 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
  - Antigo, Wisconsin, United States, 54409
    - Langlade Memorial Hospital
  - Appleton, Wisconsin, United States, 54911-3496
    - Fox Valley Hematology and Oncology - East Grant Street
  - Green Bay, Wisconsin, United States, 54311
    - Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
  - Johnson Creek, Wisconsin, United States, 53038
    - UW Cancer Center Johnson Creek
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Center for Cancer and Blood
  - La Crosse, Wisconsin, United States, 54601
    - Franciscan Skemp Healthcare - La Crosse Campus
  - Madison, Wisconsin, United States, 53792-6164
    - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  - Manitowoc, Wisconsin, United States, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, United States, 54143
    - Vince Lombardi Cancer Clinic - Marinette
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53405
    - All Saints Cancer Center at Wheaton Franciscan Healthcare
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic - Sheboygan
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic - Two Rivers
  - Wausau, Wisconsin, United States, 54401
    - University of Wisconcin Cancer Center at Aspirus Wausau Hospital
  - Wauwatosa, Wisconsin, United States, 53226
    - Oncology Alliance, SC - Milwaukee - West
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Riverview UW Cancer Center at Riverview Hospital
- 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

Description

DISEASE CHARACTERISTICS:

Histologically confirmed stage I-III invasive breast cancer
- Operable disease
- Stage I, II, IIIA, and IIIC (T1-3, N3a only)
- No T4 tumors
High-risk disease, defined by 1 of the following:
- Tumor ≥ 2 cm in greatest diameter (includes both invasive and intraductal component)
  - Patients with nodal status of N0+ (i.e., no cluster of tumor cells in any node greater than 0.2 mm) are considered to be node negative and must have a primary tumor ≥ 2 cm in size or have a tumor ≥ 1 cm with high risk features
  - Patients who are node negative on the basis of a sentinel node procedure and fewer than 6 axillary nodes are removed are eligible OR at least 6 axillary or intramammary nodes must be negative
- Tumor ≥ 1 cm in diameter and meeting 1 of the following criteria:
  - ER-negative and PgR-negative
  - ER-positive or PgR-positive with a Genomic Health Recurrence Score of ≥ 26
- One or more axillary or intramammary nodes are involved by metastatic breast cancer
  - If one or more nodes is involved, a minimum of 6 axillary or intramammary nodes must have been examined histologically
  - Patients with N0(I+) disease will be considered node negative
HER2/neu-positive tumors (3+ by immunohistochemical staining or amplified by fluorescence in-situ hybridization) allowed
Bilateral synchronous breast cancer diagnosed within 1 month of each other allowed provided the higher TNM stage primary tumor meets the eligibility criteria
Prior modified radical mastectomy OR local excision of all tumors with axillary lymph node dissection or sentinel node resection required
- No more than 84 days since prior surgery for the primary tumor and/or axilla
- Final resection margins for the primary tumor must be histologically negative for invasive cancer and ductal carcinoma in situ
- Resection margins positive for lobular carcinoma in situ are allowed
Hormone receptor status:
- Estrogen receptor status known
- Progesterone receptor status known

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Male or female

Menopausal status

Not specified

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,200/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than upper limit of normal (ULN)
Alkaline phosphatase no greater than 2 times ULN
SGOT or SGPT no greater than 2 times ULN

Renal

Creatinine no greater than ULN

Cardiovascular

No congestive heart failure
No active angina pectoris
LVEF greater than or equal to the lower limit of normal* by MUGA or echocardiogram NOTE: Patients age 60 and over OR with a history of hypertension

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical carcinoma, or lobular carcinoma in situ of the breast
- Prior invasive breast cancer or ductal carcinoma in situ allowed if disease-free for 5 years
HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior cytotoxic chemotherapy for this breast cancer
No prior chemotherapy with an anthracycline, anthracenedione, or taxane

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy for this malignancy
At least 2 weeks since prior radiotherapy for ductal carcinoma in situ

Surgery

See Disease Characteristics

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 I (closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.	Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: paclitaxel Given IV Drug: AC regimen Given IV Biological: pegfilgrastim Given IV
Experimental: Arm II (closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.	Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: paclitaxel Given IV Drug: AC regimen Given IV Biological: pegfilgrastim Given IV
Active Comparator: Arm III (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.	Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: paclitaxel Given IV Drug: AC regimen Given IV Biological: pegfilgrastim Given IV
Experimental: Arm IV (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.	Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: paclitaxel Given IV Drug: AC regimen Given IV Biological: pegfilgrastim Given IV
Experimental: Arm V Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.	Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: paclitaxel Given IV Drug: AC regimen Given IV Biological: pegfilgrastim Given IV
Experimental: Arm VI Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim as in arm V. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.	Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: paclitaxel Given IV Drug: AC regimen Given IV Biological: pegfilgrastim Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival Time Frame: every 6 months (annually for mammograms) for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.	every 6 months (annually for mammograms) for 5 years
Overall Survival Time Frame: Every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.	Every 6 months for 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Time Frame: Toxicity assessment was evaluated every 4 weeks while on protocol therapy.	Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.	Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group Time Frame: Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.	Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years
Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group Time Frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years
Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group Time Frame: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.	Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years
Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group Time Frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years
Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group Time Frame: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.	Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years
Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group. Time Frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years

Collaborators and Investigators

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

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

Study Director: Halle C Moore, MD, The Cleveland Clinic
Study Chair: George Thomas Budd, MD, The Cleveland Clinic

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

Budd GT, Barlow WE, Moore HC, Hobday TJ, Stewart JA, Isaacs C, Salim M, Cho JK, Rinn KJ, Albain KS, Chew HK, Burton GV, Moore TD, Srkalovic G, McGregor BA, Flaherty LE, Livingston RB, Lew DL, Gralow JR, Hortobagyi GN. SWOG S0221: a phase III trial comparing chemotherapy schedules in high-risk early-stage breast cancer. J Clin Oncol. 2015 Jan 1;33(1):58-64. doi: 10.1200/JCO.2014.56.3296. Epub 2014 Nov 24.
Sucheston LE, Zhao H, Yao S, Zirpoli G, Liu S, Barlow WE, Moore HC, Thomas Budd G, Hershman DL, Davis W, Ciupak GL, Stewart JA, Isaacs C, Hobday TJ, Salim M, Hortobagyi GN, Gralow JR, Livingston RB, Albain KS, Hayes DF, Ambrosone CB. Genetic predictors of taxane-induced neurotoxicity in a SWOG phase III intergroup adjuvant breast cancer treatment trial (S0221). Breast Cancer Res Treat. 2011 Dec;130(3):993-1002. doi: 10.1007/s10549-011-1671-3. Epub 2011 Jul 16.
Ambrosone CB, Sucheston LE, Zhao H, et al.: Variants in the BRCA1/Fanconi-anemia repair pathway and taxane-induced neuropathy in SWOG S0221. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-2001, 2009.

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

November 1, 2003

Primary Completion (Actual)

January 1, 2015

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 3, 2003

First Submitted That Met QC Criteria

October 6, 2003

First Posted (Estimated)

October 7, 2003

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

CDR0000334899
U10CA032102 (U.S. NIH Grant/Contract)
S0221 (Other Identifier: SWOG)

Plan for Individual participant data (IPD)

Study Data/Documents

Individual Participant Data Set
Information comments: Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

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

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

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Estimated)

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

Plan for Individual participant data (IPD)

Study Data/Documents

Clinical Trials on Breast Cancer

Clinical Trials on cyclophosphamide

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