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| Sponsor: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| ClinicalTrials.gov Identifier: | NCT00004067 |
Purpose
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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus trastuzumab is more effective than combination chemotherapy alone for treating breast cancer.
PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy together with trastuzumab works compared to combination chemotherapy alone in treating women with node-positive stage II or stage IIIA breast cancer that overexpresses HER2.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Drug: AC-T regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: endocrine-modulating drug therapy Drug: paclitaxel Drug: tamoxifen citrate Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | 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 |
| Enrollment: | 2130 |
| Study Start Date: | February 2000 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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 II) 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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically proven invasive adenocarcinoma of the breast
HER2 strongly positive (3+ by immunostain OR gene amplification by fluorescent in situ hybridization)
Must have undergone axillary dissection and either total mastectomy OR lumpectomy
No prior breast cancer, including ductal carcinoma in situ
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Comprehensive Cancer Institute | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Alaska | |
| Providence Alaska Medical Center | |
| Anchorage, Alaska, United States, 99519-6604 | |
| United States, Arizona | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, California | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609-3305 | |
| Kaiser Permanente Medical Center - Vallejo | |
| Vallejo, California, United States, 94589 | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Comprehensive Cancer Center at Desert Regional Medical Center | |
| Palm Springs, California, United States, 92262 | |
| CCOP - Santa Rosa Memorial Hospital | |
| Santa Rosa, California, United States, 95403 | |
| Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | |
| San Diego, California, United States, 92120 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Pacific Shores Medical Group Comprehensive Hematology-Oncology Services - Long Beach | |
| Long Beach, California, United States, 90813 | |
| Scripps Cancer Center at Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| Sutter Health Western Division Cancer Research Group | |
| Greenbrae, California, United States, 94904 | |
| United States, Colorado | |
| CCOP - Colorado Cancer Research Program, Incorporated | |
| Denver, Colorado, United States, 80209-5031 | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Connecticut | |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06360-7106 | |
| Helen and Harry Gray Cancer Center at Hartford Hospital | |
| Hartford, Connecticut, United States, 06102-5037 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, Florida | |
| Baptist Cancer Institute - Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| Cancer Research Network, Inc. | |
| Plantation, Florida, United States, 33324 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| University of Miami Sylvester Comprehensive Cancer Center | |
| Miami, Florida, United States, 33136 | |
| Halifax Medical Center | |
| Daytona Beach, Florida, United States, 32114 | |
| M.D. Anderson Cancer Center - Orlando | |
| Orlando, Florida, United States, 32806 | |
| Morton Plant Hospital | |
| Clearwater, Florida, United States, 33756 | |
| Florida Cancer Specialists | |
| Sarasota, Florida, United States, 34236 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| Dwight David Eisenhower Army Medical Center | |
| Fort Gordon, Georgia, United States, 30905-5650 | |
| MBCCOP-Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-4000 | |
| Phoebe Cancer Center at Phoebe Putney Memorial Hospital | |
| Albany, Georgia, United States, 31701 | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| North Idaho Cancer Center | |
| Coeur d'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| Creticos Cancer Center at Advocate Illinois Masonic Medical Center | |
| Chicago, Illinois, United States, 60657 | |
| John H. Stroger, Jr. Hospital of Cook County | |
| Chicago, Illinois, United States, 60612-9985 | |
| Rush Cancer Institute at Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| West Suburban Hospital Medical Center | |
| Oak Park, Illinois, United States, 60302 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Community Hospital | |
| Munster, Indiana, United States, 46321 | |
| Methodist Cancer Center at Methodist Hospital | |
| Indianapolis, Indiana, United States, 46206-1367 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Genesis Regional Cancer Center at Genesis Medical Center | |
| Davenport, Iowa, United States, 52803 | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Kentucky | |
| Consultants in Blood Disorders and Cancer | |
| Louisville, Kentucky, United States, 40207 | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0093 | |
| Norton Cancer Center at Norton Hospital | |
| Louisville, Kentucky, United States, 40202-5070 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane Cancer Center at Tulane University Hospital and Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medial Center | |
| Bangor, Maine, United States, 04401 | |
| United States, Maryland | |
| Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | |
| Baltimore, Maryland, United States, 21237 | |
| National Naval Medical Center | |
| Bethesda, Maryland, United States, 20889-5000 | |
| United States, Massachusetts | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | |
| Springfield, Massachusetts, United States, 01199 | |
| Berkshire Medical Center | |
| Pittsfield, Massachusetts, United States, 01201 | |
| Cancer Research Center at Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Josephine Ford Cancer Center at Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| Michigan State University | |
| East Lansing, Michigan, United States, 48824 | |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | |
| Southfield, Michigan, United States, 48075-9975 | |
| William Beaumont Hospital - Royal Oak | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Hennepin County Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Missouri Baptist Cancer Center | |
| Saint Louis, Missouri, United States, 63131 | |
| Saint Louis University Cancer Center | |
| Saint Louis, Missouri, United States, 63110-0250 | |
| United States, Montana | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13217 | |
| Charles R. Wood Cancer Center at Glens Falls Hospital | |
| Glens Falls, New York, United States, 12801 | |
| New York Oncology Hematology, P.C. at Albany Regional Cancer Care | |
| Albany, New York, United States, 12208 | |
| MBCCOP-Our Lady of Mercy Cancer Center | |
| Bronx, New York, United States, 10466 | |
| Nalitt Cancer Institute at Staten Island University Hospital | |
| Staten Island, New York, United States, 10305 | |
| Lincoln Medical and Mental Health Center | |
| Bronx, New York, United States, 10451 | |
| United States, North Carolina | |
| Alamance Cancer Center | |
| Burlington, North Carolina, United States, 27216 | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | |
| Greenville, North Carolina, United States, 27858-4354 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Akron City Hospital at Summa Health System | |
| Akron, Ohio, United States, 44309 | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Aultman Hospital Cancer Center at Aultman Health Foundation | |
| Canton, Ohio, United States, 44710 | |
| Cancer Care Center at Northside Medical Center | |
| Youngstown, Ohio, United States, 44501 | |
| Cancer Center at Jewish Hospital | |
| Cincinnati, Ohio, United States, 45236 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Dayton | |
| Kettering, Ohio, United States, 45429 | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267-0502 | |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106-5065 | |
| South Pointe Hospital Cancer Care Center | |
| Cleveland, Ohio, United States, 44122 | |
| United States, Oklahoma | |
| CCOP - Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Albert Einstein Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212-4772 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18103 | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| Mercy Hospital Cancer Center - Scranton | |
| Scranton, Pennsylvania, United States, 18501 | |
| York Cancer Center at Wellspan Health | |
| York, Pennsylvania, United States, 17315 | |
| United States, Rhode Island | |
| Kent County Memorial Hospital | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410-1894 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| United States, Utah | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| United States, Vermont | |
| Vermont Cancer Center at University of Vermont | |
| Burlington, Vermont, United States, 05405-0075 | |
| United States, Virginia | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Sentara Cancer Institute at Sentara Norfolk General Hospital | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| CCOP - Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
| Puget Sound Oncology Consortium | |
| Seattle, Washington, United States, 98109 | |
| United States, West Virginia | |
| Camden-Clark Memorial Hospital | |
| Parkersburg, West Virginia, United States, 26102 | |
| David Lee Cancer Center at Charleston Area Medical Center | |
| Charleston, West Virginia, United States, 25304-1297 | |
| United States, Wisconsin | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Oncology Alliance, S.C. - Milwaukee | |
| Milwaukee, Wisconsin, United States, 53211-2906 | |
| St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Ontario | |
| Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital | |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| Canada, Quebec | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Hopital du Saint-Sacrement, Quebec | |
| Quebec City, Quebec, Canada, G1S 4L8 | |
| St. Mary's Hospital Center | |
| Montreal, Quebec, Canada, H3T 1M5 | |
| Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Royal Victoria Hospital - Montreal | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Jewish General Hospital - Montreal | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Study Chair: | Edward H. Romond, MD | Lucille P. Markey Cancer Center at University of Kentucky |
More Information
| Responsible Party: | NSABP Foundation, Inc. ( Norman Wolmark, MD ) |
| Study ID Numbers: | NSABP B-31, CDR0000067269 |
| Study First Received: | December 10, 1999 |
| Last Updated: | August 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004067 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IIIA breast cancer |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Cyclophosphamide Antibiotics, Antineoplastic Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Neoplasms by Site Therapeutic Uses Trastuzumab Alkylating Agents |
Breast Diseases Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Mitosis Modulators Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Tamoxifen Doxorubicin Pharmacologic Actions Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists |