A Three-Arm Randomized Trial to Compare Adjuvant Adriamycin and Cyclophosphamide Followed by Taxotere (AC-T); Adriamycin and Taxotere (AT); and Adriamycin, Taxotere, and Cyclophosphamide (ATC) in Breast Cancer Patients With Positive Axillary Lymph Nodes
OBJECTIVES:
- Compare the efficacy of adjuvant doxorubicin, cyclophosphamide, and docetaxel given
concurrently vs adjuvant doxorubicin and cyclophosphamide followed by docetaxel, in
terms of overall survival and disease-free survival, of women with breast cancer and
positive axillary lymph nodes.
- Compare the efficacy of adjuvant doxorubicin and docetaxel vs regimens containing
cyclophosphamide in these patients.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens. (Quality of life
substudy closed to accrual as of 7/20/01.)
- Compare the differences in amenorrhea in premenopausal women in each treatment arm and
its relationship to symptoms, quality of life (quality of life substudy closed to
accrual as of 7/20/01), disease-free survival, and overall survival.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, number of positive nodes (1-3 vs 4-9 vs at least 10), sequential
tamoxifen or anastrozole administration (yes vs no), and type of prior surgery and
radiotherapy plan (mastectomy with no local or regional radiotherapy vs mastectomy with
local and/or regional radiotherapy vs lumpectomy with local radiotherapy vs lumpectomy with
local and regional radiotherapy). Patients are randomized to one of three treatment arms.
- Arm 1: Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30
minutes every 21 days for 4 courses. Three weeks after the last dose of this
combination, patients receive docetaxel IV over 1 hour every 21 days for 4 courses.
- Arm 2: Patients receive doxorubicin IV over 15 minutes and docetaxel IV over 1 hour
every 21 days for 4 courses.
- Arm 3: Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 30
minutes, and docetaxel IV over 1 hour every 21 days for 4 courses.
Patients in all arms who are estrogen receptor-positive and/or progesterone
receptor-positive receive oral tamoxifen daily for 5 years beginning within 3-12 weeks of
completion of chemotherapy. Patients who are postmenopausal may receive alternative hormonal
therapy at the discretion of the treating physician.
Some patients may receive postmastectomy radiotherapy on SWOG-S9927 or NCIC-MA.20 after
recovery from chemotherapy.
Quality of life and menstrual history are assessed before randomization, on day 1 of course
4, and at 6, 12, 18, and 24 months. (Quality of life substudy closed to accrual as of
7/20/01.)
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 5,300 patients will be accrued for this study within 4-5
years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
8 years
No
Norman Wolmark, MD
Principal Investigator
NSABP Foundation, Inc.
United States: Federal Government
NSABP B-30
NCT00003782
March 1999
December 2012
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Baylor College of Medicine | Houston, Texas 77030 |
National Naval Medical Center | Bethesda, Maryland 20889 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
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 |
St. Vincent Hospital and Health Care Center | Indianapolis, Indiana 46260 |
Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana 46202 |
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 |
MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
California Cancer Center | Fresno, California 93720 |
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 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
CCOP - Evanston | Evanston, Illinois 60201 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
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 |
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 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
Baptist Regional Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
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 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Sarasota Memorial Hospital | Sarasota, Florida 34239 |
Medical College of Georgia Comprehensive Cancer Center | Augusta, Georgia 30912-4000 |
Eastern Maine Medical Center | Bangor, Maine 04401 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
Berkshire Medical Center | Pittsfield, Massachusetts 01201 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
Michigan State University | East Lansing, Michigan 48824 |
Staten Island University Hospital | Staten Island, New York 10305 |
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 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Virginia Oncology Associates - Newport News | Newport News, Virginia 23606 |
Eastern Virginia Medical School | Norfolk, Virginia 23507 |
Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke, Virginia 24014 |
Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
Providence Alaska Medical Center | Anchorage, Alaska 99508 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego, California 92120 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
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 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
Comprehensive Cancer Centers of the Desert | Palm Springs, California 92262 |
Catholic Healthcare West - Westbay Region | San Francisco, California 94107-1728 |
North Idaho Cancer Center | Coeur d'Alene, Idaho 83814 |
Stanford Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Scripps Cancer Center at Scripps Clinic | La Jolla, California 92037 |
Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
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 |
Wellspan Health - York Cancer Center | York, Pennsylvania 17403 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
Comprehensive Cancer Institute | Huntsville, Alabama 35801 |
MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina | Greenville, North Carolina 27858-4354 |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390-9063 |
MBCCOP-Our Lady of Mercy Cancer Center | Bronx, New York 10466 |
Charleston Area Medical Center | Charleston, West Virginia 25304 |
Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago, Illinois 60657 |
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown, Pennsylvania 18105 |
Pacific Shores Medical Group | Long Beach, California 90813 |
Genesis Medical Center | Davenport, Iowa 52804 |
Providence Cancer Institute at Providence Hospital | Southfield, Michigan 48075 |
University of Connecticut Cancer Center at University of Connecticut Health Center | Farmington, Connecticut 06360-7106 |
Morton Plant Hospital | Clearwater, Florida 33756 |
University of Miami Sylvester Cancer Center | Miami, Florida 33136 |
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 |
Norton Healthcare Cancer Center | Louisville, Kentucky 40202-5070 |
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans | New Orleans, Louisiana 70112 |
Tulane University Medical Center | New Orleans, Louisiana 70112 |
New York Oncology Hematology, P.C. - Albany Regional Cancer Center | Albany, New York 12208 |
Lincoln Medical and Mental Health Center | Bronx, New York 10451 |
Charles R. Wood Foundation Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Alamance Cancer Center | Burlington, North Carolina 27216 |
Jewish Hospital of Cincinnati, Incorporated | Cincinnati, Ohio 45236 |
South Pointe Hospital - Cancer Care Center | Warrensville Heights, Ohio 44122 |
Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis | Memphis, Tennessee 38146 |