A Randomized Trial Comparing the Safety and Efficacy of Adriamycin and Cyclophosphamide Followed by Taxol (AC-T) to That of Adriamycin and Cyclophosphamide Followed by Taxol Plus Herceptin (AC-T+H) in Node-Positive Breast Cancer Patients Who Have Tumors That Overexpress HER2
OBJECTIVES:
- Compare the cardiotoxicity of doxorubicin and cyclophosphamide followed by paclitaxel
with or without trastuzumab (Herceptin®) in women with operable, node-positive breast
cancer that overexpresses HER2.
- Compare the effect of these regimens on disease-free and overall survival of these
patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
number of positive nodes (1-3 vs 4-9 vs 10 or more), administration of hormonal therapy
(tamoxifen vs anastrozole vs neither), surgery/radiotherapy (lumpectomy plus breast
irradiation vs lumpectomy plus breast irradiation plus regional irradiation vs mastectomy
without radiotherapy vs mastectomy with radiotherapy), paclitaxel schedule (every 3 weeks vs
weekly), and participating center. Patients are randomized to one of two treatment arms.
- Arm 1: Patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day
1. Treatment repeats every 21 days for 4 courses. Approximately 3 weeks after the last
course, patients receive paclitaxel IV over 3 hours every 21 days for 4 courses OR
paclitaxel IV over 1 hour once weekly for 12 weeks (12 doses).
- Arm 2: Patients receive chemotherapy as in arm I and trastuzumab (Herceptin®) IV over
90 minutes on day 1 of the first course of paclitaxel. Trastuzumab is then administered
IV over 30 minutes weekly for 51 weeks, beginning on day 8.
All patients with estrogen or progesterone receptor-positive tumors receive hormonal
therapy* for at least 5 years, beginning within 3-12 weeks after the last dose of
chemotherapy. Patients who have received prior tamoxifen for prevention may be treated with
additional tamoxifen for no more than 5 years at the discretion of the principal
investigator (PI).
NOTE: *Other hormonal therapeutic agents are allowed in sequence with or as an alternative
to tamoxifen therapy.
All patients previously treated with lumpectomy undergo breast irradiation beginning after
completion of chemotherapy and concurrently with trastuzumab (in arm 2) administration.
Patients previously treated with mastectomy may also receive radiotherapy. Radiotherapy is
administered daily for 5-6 weeks.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,700 patients will be accrued for this study within 4.75
years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease Free Survival (DFS)
Breast cancer recurrence, second primary cancer, death from any cause as first event
Time from randomization through 5 years
No
Norman Wolmark, MD
Principal Investigator
NSABP Foundation, Inc.
United States: Federal Government
NSABP B-31
NCT00004067
February 2000
March 2014
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
National Naval Medical Center | Bethesda, Maryland 20889 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington, Connecticut 06360-2875 |
Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana 46202 |
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Sutter Health Western Division Cancer Research Group | Greenbrae, California 94904 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
Halifax Medical Center | Daytona Beach, Florida 32114 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Puget Sound Oncology Consortium | Seattle, Washington 98109 |
Sutter Cancer Center | Sacramento, California 95816 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
West Suburban Hospital Medical Center | Oak Park, Illinois 60302 |
Berkshire Medical Center | Pittsfield, Massachusetts 01201 |
Michigan State University | East Lansing, Michigan 48824 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
Kent County Memorial Hospital | Warwick, Rhode Island 02886 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
Providence Alaska Medical Center | Anchorage, Alaska 99508 |
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego, California 92120 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore, Maryland 21237 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
North Idaho Cancer Center | Coeur d'Alene, Idaho 83814 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
CancerCare of Maine at Eastern Maine Medial Center | Bangor, Maine 04401 |
Scripps Cancer Center at Scripps Clinic | La Jolla, California 92037 |
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha, Nebraska 68114-4199 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
Comprehensive Cancer Institute | Huntsville, Alabama 35801 |
Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
MBCCOP-Medical College of Georgia Cancer Center | Augusta, Georgia 30912-4000 |
William Beaumont Hospital - Royal Oak | Royal Oak, Michigan 48073-6769 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | Greenville, North Carolina 27858-4354 |
MBCCOP-Our Lady of Mercy Cancer Center | Bronx, New York 10466 |
Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
M.D. Anderson Cancer Center - Orlando | Orlando, Florida 32806 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield, Michigan 48075 |
Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago, Illinois 60657 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Akron City Hospital at Summa Health System | Akron, Ohio 44304 |
South Pointe Hospital Cancer Care Center | Warrensville Heights, Ohio 44122 |
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown, Pennsylvania 18105 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Morton Plant Hospital | Clearwater, Florida 33756 |
John H. Stroger, Jr. Hospital of Cook County | Chicago, Illinois 60612-9985 |
Community Hospital | Munster, Indiana 46321 |
Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans | New Orleans, Louisiana 70112 |
Lincoln Medical and Mental Health Center | Bronx, New York 10451 |
Alamance Cancer Center | Burlington, North Carolina 27216 |
Phoebe Cancer Center at Phoebe Putney Memorial Hospital | Albany, Georgia 31702 |
York Cancer Center at Wellspan Health | York, Pennsylvania 17403 |
Pacific Shores Medical Group Comprehensive Hematology-Oncology Services - Long Beach | Long Beach, California 90813 |
Rush Cancer Institute at Rush University Medical Center | Chicago, Illinois 60612 |
David Lee Cancer Center at Charleston Area Medical Center | Charleston, West Virginia 25304-1297 |
Comprehensive Cancer Center at Desert Regional Medical Center | Palm Springs, California 92262 |
Cancer Research Network, Inc. | Plantation, Florida 33324 |
Norton Cancer Center at Norton Hospital | Louisville, Kentucky 40202-5070 |
New York Oncology Hematology, P.C. at Albany Regional Cancer Care | Albany, New York 12208 |
Nalitt Cancer Institute at Staten Island University Hospital | Staten Island, New York 10305 |
Cancer Center at Jewish Hospital | Cincinnati, Ohio 45236 |
Cancer Care Center at Northside Medical Center | Youngstown, Ohio 44501 |
Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |
Oncology Alliance, S.C. - Milwaukee | Milwaukee, Wisconsin 53211-2906 |