S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer, stage IA breast cancer, stage IB breast cancer, stage IIIC breast cancer, male breast cancer, HER2-positive breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer
Eligibility Criteria
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
Sites / Locations
- Regional Medical Center
- UAB Comprehensive Cancer Center
- Providence Cancer Center at Providence Hospital
- Providence Cancer Center
- Mayo Clinic Scottsdale
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Alta Bates Summit Comprehensive Cancer Center
- Peninsula Medical Center
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants - Castro Valley
- Valley Medical Oncology
- California Cancer Center - Woodward Park Office
- Todd Cancer Institute at Long Beach Memorial Medical Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Contra Costa Regional Medical Center
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP
- Memorial Medical Center
- El Camino Hospital Cancer Center
- Sutter Health - Western Division Cancer Research Group
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons, Incorporated
- CCOP - Bay Area Tumor Institute
- Larry G Strieff MD Medical Corporation
- Tom K Lee, Incorporated
- St. Joseph Hospital Regional Cancer Center - Orange
- Desert Regional Medical Center Comprehensive Cancer Center
- Valley Medical Oncology Consultants - Pleasanton
- Sutter Cancer Center at Roseville Medical Center
- Sutter Cancer Center
- University of California Davis Cancer Center
- UCSF Helen Diller Family Comprehensive Cancer Center
- California Pacific Medical Center - California Campus
- Doctors Medical Center - San Pablo Campus
- Sutter Solano Medical Center
- San Luis Valley Regional Medical Center
- University of Colorado Cancer Center at UC Health Sciences Center
- Memorial Hospital Cancer Center - Colorado Springs
- Denver Health Medical Center
- Veterans Affairs Medical Center - Denver
- Shaw Regional Cancer Center
- Valley View Hospital Cancer Center
- Montrose Memorial Hospital Cancer Center
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Yale Cancer Center
- Washington Cancer Institute at Washington Hospital Center
- Herbert D. Kerman Regional Oncology Center - Daytona Beach
- Florida Hospital Memorial Medical Center
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Mayo Clinic - Jacksonville
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- WellStar Cobb Hospital
- John B. Amos Cancer Center
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Piedmont Fayette Hospital
- Dwight David Eisenhower Army Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Cancer Center - Medical Oncology
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Kapiolani Medical Center at Pali Momi
- Cancer Research Center of Hawaii
- OnCare Hawaii, Incorporated - Lusitana
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- Hawaii Medical Center - East
- OnCare Hawaii, Incorporated - Kuakini
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Castle Medical Center
- Kauai Medical Clinic
- Maui Memorial Medical Center
- Pacific Cancer Institute - Maui
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Kootenai Cancer Center - Coeur d'Alene
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Rush-Copley Cancer Care Center
- Illinois CancerCare - Bloomington
- St. Joseph Medical Center
- Graham Hospital
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Memorial Hospital
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Resurrection Medical Center
- Saint Joseph Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Sherman Hospital
- Elmhurst Memorial Hospital
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- St. Francis Hospital
- Galesburg Clinic, PC
- Illinois CancerCare - Galesburg
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
- Illinois CancerCare - Havana
- Mason District Hospital
- Kellogg Cancer Care Center
- Joliet Oncology-Hematology Associates, Limited - West
- Provena St. Mary's Regional Cancer Center - Kankakee
- Illinois CancerCare - Kewanee Clinic
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Illinois CancerCare - Macomb
- McDonough District Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Illinois CancerCare - Monmouth
- OSF Holy Family Medical Center
- Good Samaritan Regional Health Center
- Edward Hospital Cancer Center
- Hematology Oncology Consultants - Naperville
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Illinois CancerCare - Pekin
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Perry Memorial Hospital
- Swedish-American Regional Cancer Center
- Hematology Oncology Associates - Skokie
- Illinois CancerCare - Spring Valley
- Regional Cancer Center at Memorial Medical Center
- CCOP - Carle Cancer Center
- Central Dupage Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart Clinic, LLC
- Michiana Hematology-Oncology, PC - Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- Michiana Hematology-Oncology, PC - South Bend
- Saint Joseph Regional Medical Center
- Michiana Hematology Oncology PC - Plymouth
- Reid Hospital & Health Care Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC - La Porte
- McFarland Clinic, PC
- Hematology Oncology Associates of the Quad Cities
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Heartland Oncology and Hematology
- Genesis Regional Cancer Center at Genesis Medical Center
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Hays Medical Center
- Hutchinson Hospital Corporation
- Cancer Center of Kansas-Independence
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - Newton
- Menorah Medical Center
- Saint Luke's Hospital - South
- Cancer Center of Kansas, PA - Parsons
- Mount Carmel Regional Cancer Center
- CCOP - Kansas City
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cotton-O'Neil Cancer Center
- St. Francis Comprehensive Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Tulane Cancer Center Office of Clinical Research
- Ochsner Health Center - Bluebonnet
- Ochsner Health Center - Covington
- Louisiana State University Health Sciences Center - Monroe
- New Orleans Cancer Institute at Memorial Medical Center
- CCOP - Ochsner
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- Christus Schumpert Cancer Treatment Center
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- St. Agnes Hospital Cancer Center
- Regional Cancer Center at Western Maryland Health System - Sacred Heart Campus
- Peninsula Regional Medical Center
- Caritas St. Elizabeth's Medical Center
- Addison Gilbert Hospital
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Bay Regional Medical Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Barbara Ann Karmanos Cancer Institute
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Breslin Cancer Center at Ingham Regional Medical Center
- Sparrow Regional Cancer Center
- Lapeer Regional Hospital
- St. Mary Mercy Hospital
- MidMichigan Medical Center - Midland
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- Clemens Regional Medical Center
- Mercy General Health Partners
- Michiana Hematology Oncology PC - Niles
- Northern Michigan Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- William Beaumont Hospital - Royal Oak Campus
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeland Regional Cancer Care Center - St. Joseph
- Lakeside Cancer Specialists, PLLC
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- Munson Medical Center
- St. John Macomb Hospital
- Metro Health Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CentraCare Clinic - River Campus
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology Hematology, PA - Woodbury
- Keesler Air Force Base Medical Center
- Regional Cancer Center at Singing River Hospital
- Saint Francis Medical Center
- Southeast Cancer Center
- Goldschmidt Cancer Center
- Freeman Cancer Institute at Freeman Health System
- St. John's Regional Medical Center
- Truman Medical Center - Hospital Hill
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- St. Joseph Medical Center
- North Kansas City Hospital
- Parvin Radiation Oncology
- Heartland Hematology Oncology Associates, Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Hospital
- Heartland Regional Medical Center
- Saint Joseph Oncology, Incorporated
- Midwest Hematology Oncology Group, Incorporated
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Missouri Baptist Cancer Center
- CCOP - St. Louis-Cape Girardeau
- Comprehensive Cancer Care, PC
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Lakeside Hospital
- Creighton University Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
- New Hampshire Oncology - Hematology, PA - Hooksett
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
- CCOP - Northern New Jersey
- St. Barnabas Medical Center Cancer Center
- UMDNJ University Hospital
- Somerset Medical Center
- Overlook Hospital
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- Hematology Oncology Associates, PC
- Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
- University of New Mexico Cancer Center
- University of New Mexico Cancer Center - South
- Roswell Park Cancer Institute
- CCOP - Hematology-Oncology Associates of Central New York
- Beth Israel Medical Center - Petrie Division
- New York Weill Cornell Cancer Center at Cornell University
- St. Luke's - Roosevelt Hospital Center - St.Luke's Division
- Union State Bank Cancer Center at Nyack Hospital
- Highland Hospital of Rochester
- Lipson Cancer and Blood Center at Rochester General Hospital
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Hope A Women's Cancer Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Batte Cancer Center at Northeast Medical Center
- Wayne Memorial Hospital, Incorporated
- Kinston Medical Specialists
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- Altru Cancer Center at Altru Hospital
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Cleveland Clinic Beachwood Family Health and Surgery Center
- Mary Rutan Hospital
- Wood County Oncology Center
- Mercy Cancer Center at Mercy Medical Center
- Adena Regional Medical Center
- Good Samaritan Hospital Cancer Treatment Center
- Bethesda North Hospital
- Case Comprehensive Cancer Center
- Cleveland Clinic Cancer Center at Fairview Hospital
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Grady Memorial Hospital
- Community Cancer Center
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- St. Rita's Medical Center
- Lima Memorial Hospital
- MedCentral - Mansfield Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- Hillcrest Cancer Center at Hillcrest Hospital
- Knox Community Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Fisher-Titus Medical Center
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Parma Community General Hospital
- North Coast Cancer Care, Incorporated
- Community Hospital of Springfield and Clark County
- Cleveland Clinic Foundation - Strongsville
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Mount Carmel St. Ann's Cancer Center
- Cleveland Clinic - Wooster
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Cleo Craig Cancer Research Clinic
- Cancer Care Associates - Norman
- Cancer Care Associates - Mercy Campus
- Cancer Care Associates at Troy and Dollie Smith Cancer Center
- Clackamas Radiation Oncology Center
- Bay Area Hospital
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Willamette Falls Hospital
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Knight Cancer Institute at Oregon Health and Science University
- Butler Memorial Hospital
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
- Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
- Lewistown Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- Pottstown Memorial Regional Cancer Center
- Guthrie Cancer Center at Guthrie Clinic Sayre
- Mercy Hospital Cancer Center - Scranton
- Hematology and Oncology Associates of Northeastern Pennsylvania
- Mount Nittany Medical Center
- Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
- Susquehanna Cancer Center at Divine Providence Hospital
- South Carolina Oncology Associates, PA
- Cancer Centers of the Carolinas - Easley
- McLeod Regional Medical Center
- Cancer Centers of the Carolinas - Faris Road
- Cancer Centers of the Carolinas - Grove Commons
- Greenville Hospital Cancer Center
- CCOP - Greenville
- Self Regional Cancer Center at Self Regional Medical Center
- Cancer Centers of the Carolinas - Greer Medical Oncology
- Cancer Centers of the Carolinas - Seneca
- Cancer Centers of the Carolinas - Spartanburg
- Rapid City Regional Hospital
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- University of Tennessee Cancer Institute - Memphis
- MBCCOP - Meharry Medical College - Nashville
- Texas Tech University Health Sciences Center School of Medicine - El Paso
- University of Texas Medical Branch
- UMC Southwest Cancer and Research Center
- Veterans Affairs Medical Center - San Antonio (Murphy)
- University of Texas Health Science Center at San Antonio
- University Hospital - San Antonio
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Logan Regional Hospital
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- Green Mountain Oncology Group
- Fredericksburg Oncology, Incorporated
- Hematology-Oncology Associates of Fredericksburg, Incorporated
- Island Hospital Cancer Care Center at Island Hospital
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Highline Medical Center Cancer Center
- Providence Centralia Hospital
- St. Francis Hospital
- Columbia Basin Hematology
- Skagit Valley Hospital Cancer Care Center
- Providence St. Peter Hospital Regional Cancer Center
- Harrison Poulsbo Hematology and Onocology
- Good Samaritan Cancer Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Providence Cancer Center at Sacred Heart Medical Center
- Evergreen Hematology and Oncology, PS
- Franciscan Cancer Center at St. Joseph Medical Center
- Allenmore Hospital
- CCOP - Northwest
- MultiCare Regional Cancer Center at Tacoma General Hospital
- Madigan Army Medical Center - Tacoma
- St. Clare Hospital
- Southwest Washington Medical Center Cancer Center
- Northwest Cancer Specialists at Vancouver Cancer Center
- Wenatchee Valley Medical Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Princeton Community Hospital
- Langlade Memorial Hospital
- Fox Valley Hematology and Oncology - East Grant Street
- Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Franciscan Skemp Healthcare - La Crosse Campus
- Gundersen Lutheran Center for Cancer and Blood
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Vince Lombardi Cancer Clinic - Marinette
- Vince Lombardi Cancer Clinic - Oshkosh
- All Saints Cancer Center at Wheaton Franciscan Healthcare
- Vince Lombardi Cancer Clinic - Sheboygan
- Aurora Medical Center
- Vince Lombardi Cancer Clinic - Two Rivers
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Oncology Alliance, SC - Milwaukee - West
- Riverview UW Cancer Center at Riverview Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
- Cancer Care Program at Thunder Bay Regional Health Sciences
- Allan Blair Cancer Centre at Pasqua Hospital
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Experimental
Active Comparator
Experimental
Experimental
Experimental
Arm I
Arm II
Arm III
Arm IV
Arm V
Arm VI
(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.
(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.
(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.
(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.
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.
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.