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Spots Global Cancer Trial Database for Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2

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Trial Identification

Brief Title: Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2

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

Study ID: NCT00004067

Conditions

Breast Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Comprehensive Cancer Institute, Huntsville, Alabama, United States

Providence Alaska Medical Center, Anchorage, Alaska, United States

CCOP - Western Regional, Arizona, Phoenix, Arizona, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

Sutter Health Western Division Cancer Research Group, Greenbrae, California, United States

Scripps Cancer Center at Scripps Clinic, La Jolla, California, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States

Pacific Shores Medical Group Comprehensive Hematology-Oncology Services - Long Beach, Long Beach, California, United States

CCOP - Bay Area Tumor Institute, Oakland, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, United States

Comprehensive Cancer Center at Desert Regional Medical Center, Palm Springs, California, United States

Sutter Cancer Center, Sacramento, California, United States

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego, California, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States

Kaiser Permanente Medical Center - Vallejo, Vallejo, California, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado, United States

CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, United States

Helen and Harry Gray Cancer Center at Hartford Hospital, Hartford, Connecticut, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware, United States

Morton Plant Hospital, Clearwater, Florida, United States

Halifax Medical Center, Daytona Beach, Florida, United States

Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

M.D. Anderson Cancer Center - Orlando, Orlando, Florida, United States

Cancer Research Network, Inc., Plantation, Florida, United States

Florida Cancer Specialists, Sarasota, Florida, United States

Phoebe Cancer Center at Phoebe Putney Memorial Hospital, Albany, Georgia, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia, United States

CCOP - Atlanta Regional, Atlanta, Georgia, United States

MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia, United States

Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii, United States

North Idaho Cancer Center, Coeur d'Alene, Idaho, United States

John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois, United States

Rush Cancer Institute at Rush University Medical Center, Chicago, Illinois, United States

Creticos Cancer Center at Advocate Illinois Masonic Medical Center, Chicago, Illinois, United States

CCOP - Central Illinois, Decatur, Illinois, United States

CCOP - Evanston, Evanston, Illinois, United States

West Suburban Hospital Medical Center, Oak Park, Illinois, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

Methodist Cancer Center at Methodist Hospital, Indianapolis, Indiana, United States

Community Hospital, Munster, Indiana, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States

Genesis Regional Cancer Center at Genesis Medical Center, Davenport, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States

CCOP - Wichita, Wichita, Kansas, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States

Norton Cancer Center at Norton Hospital, Louisville, Kentucky, United States

Consultants in Blood Disorders and Cancer, Louisville, Kentucky, United States

Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans, New Orleans, Louisiana, United States

Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, United States

CCOP - Ochsner, New Orleans, Louisiana, United States

CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, United States

Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center, Baltimore, Maryland, United States

National Naval Medical Center, Bethesda, Maryland, United States

Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States

Berkshire Medical Center, Pittsfield, Massachusetts, United States

Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts, United States

UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States

Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, United States

Michigan State University, East Lansing, Michigan, United States

CCOP - Grand Rapids, Grand Rapids, Michigan, United States

CCOP - Kalamazoo, Kalamazoo, Michigan, United States

William Beaumont Hospital - Royal Oak, Royal Oak, Michigan, United States

Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield, Michigan, United States

CCOP - Duluth, Duluth, Minnesota, United States

Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States

CCOP - Kansas City, Kansas City, Missouri, United States

Saint Louis University Cancer Center, Saint Louis, Missouri, United States

Missouri Baptist Cancer Center, Saint Louis, Missouri, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States

CCOP - Montana Cancer Consortium, Billings, Montana, United States

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha, Nebraska, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

CCOP - Northern New Jersey, Hackensack, New Jersey, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center, Newark, New Jersey, United States

University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States

New York Oncology Hematology, P.C. at Albany Regional Cancer Care, Albany, New York, United States

Lincoln Medical and Mental Health Center, Bronx, New York, United States

MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, United States

Charles R. Wood Cancer Center at Glens Falls Hospital, Glens Falls, New York, United States

Nalitt Cancer Institute at Staten Island University Hospital, Staten Island, New York, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States

Alamance Cancer Center, Burlington, North Carolina, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital, Greenville, North Carolina, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

Akron City Hospital at Summa Health System, Akron, Ohio, United States

Aultman Hospital Cancer Center at Aultman Health Foundation, Canton, Ohio, United States

Cancer Center at Jewish Hospital, Cincinnati, Ohio, United States

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, United States

South Pointe Hospital Cancer Care Center, Cleveland, Ohio, United States

CCOP - Columbus, Columbus, Ohio, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States

CCOP - Dayton, Kettering, Ohio, United States

Cancer Care Center at Northside Medical Center, Youngstown, Ohio, United States

CCOP - Oklahoma, Tulsa, Oklahoma, United States

CCOP - Columbia River Oncology Program, Portland, Oregon, United States

John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States

Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

Mercy Hospital Cancer Center - Scranton, Scranton, Pennsylvania, United States

York Cancer Center at Wellspan Health, York, Pennsylvania, United States

Kent County Memorial Hospital, Warwick, Rhode Island, United States

CCOP - Greenville, Greenville, South Carolina, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States

Medical City Dallas Hospital, Dallas, Texas, United States

Baylor College of Medicine, Houston, Texas, United States

Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

CCOP - Scott and White Hospital, Temple, Texas, United States

Utah Valley Regional Medical Center - Provo, Provo, Utah, United States

Vermont Cancer Center at University of Vermont, Burlington, Vermont, United States

Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia, United States

CCOP - Virginia Mason Research Center, Seattle, Washington, United States

Puget Sound Oncology Consortium, Seattle, Washington, United States

CCOP - Northwest, Tacoma, Washington, United States

David Lee Cancer Center at Charleston Area Medical Center, Charleston, West Virginia, United States

Camden-Clark Memorial Hospital, Parkersburg, West Virginia, United States

St. Vincent Hospital, Green Bay, Wisconsin, United States

CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States

Oncology Alliance, S.C. - Milwaukee, Milwaukee, Wisconsin, United States

Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital, Mississauga, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada

Royal Victoria Hospital - Montreal, Montreal, Quebec, Canada

Montreal General Hospital, Montreal, Quebec, Canada

Jewish General Hospital - Montreal, Montreal, Quebec, Canada

St. Mary's Hospital Center, Montreal, Quebec, Canada

Hopital du Saint-Sacrement, Quebec, Quebec City, Quebec, Canada

Contact Details

Name: Norman Wolmark, MD

Affiliation: NSABP Foundation Inc

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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