Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed
NCT ID: NCT00002707
Last Updated: 2010-02-03
Study Results
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Basic Information
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COMPLETED
PHASE3
2411 participants
INTERVENTIONAL
1995-12-31
2010-02-28
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy using doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage II or stage III breast cancer.
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Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), clinical tumor size (less than 2.1 cm vs 2.1-4.0 cm vs greater than 4.0 cm), clinical nodal status (negative vs positive), and participating center. Patients are randomized to one of three treatment arms. Arm I: Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4 courses. Patients receive oral tamoxifen daily for 5 years, starting on day 1. After completion of chemotherapy, patients are offered surgery (e.g., lumpectomy with axillary node dissection, or modified radical mastectomy). Post-operative radiotherapy is given post-lumpectomy. Arm II: Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours followed by docetaxel IV over 1 hour on day 1 once every 21 days for 4 courses. Patients receive oral tamoxifen daily for 5 years, starting on day 1. After the completion of chemotherapy, surgery is offered (as in arm I). Radiotherapy follows surgery in post-lumpectomy patients. Arm III: Patients receive doxorubicin IV followed by cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4 courses. Patients receive oral tamoxifen daily for 5 years, starting on day 1. After completion of chemotherapy, surgery is offered (as in arm I). After surgical recovery, docetaxel IV is given over 1 hour once every 21 days for 4 courses. Radiotherapy follows docetaxel in post-lumpectomy patients. Chemotherapy is repeated every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 2,400 patients will be accrued for this study within 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 2
doxorubicin and cyclophosphamide plus Taxotere prior to surgery plus tamoxifen
Cyclophosphamide
600 mg/m2 IV every 21 days for 4 cycles
Docetaxel
100 mg/m2 IV every 21 days for 4 cycles
Doxorubicin
60 mg/m2 IV every 21 days fo 4 cycles
Tamoxifen
20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle
Group 3
doxorubicin and cyclophosphamide followed by surgery followed by taxotere plus tamoxifen
Cyclophosphamide
600 mg/m2 IV every 21 days for 4 cycles
Docetaxel
100 mg/m2 IV every 21 days for 4 cycles
Doxorubicin
60 mg/m2 IV every 21 days fo 4 cycles
Tamoxifen
20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle
Group 1
doxorubicin and cyclophosphamide plus tamoxifen
Cyclophosphamide
600 mg/m2 IV every 21 days for 4 cycles
Doxorubicin
60 mg/m2 IV every 21 days fo 4 cycles
Tamoxifen
20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle
Interventions
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Cyclophosphamide
600 mg/m2 IV every 21 days for 4 cycles
Docetaxel
100 mg/m2 IV every 21 days for 4 cycles
Doxorubicin
60 mg/m2 IV every 21 days fo 4 cycles
Tamoxifen
20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: At least 10 years (exclusive of cancer diagnosis) Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT normal Alkaline phosphatase normal Renal: Creatinine normal Cardiovascular: No active cardiac disease that would preclude doxorubicin, e.g.: Documented myocardial infarction History of congestive heart failure Angina pectoris requiring medication Valvular disease with documented cardiac function compromise Arrhythmia associated with heart failure or cardiac dysfunction Poorly controlled hypertension, i.e., diastolic blood pressure greater than 100 mm Hg Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG unless left ventricular ejection fraction at least 45% by MUGA Other: No other malignancy within the past 10 years except: Segmentally resected lobular carcinoma in situ of the ipsilateral or contralateral breast Effectively treated nonmelanomatous skin cancer Surgically treated carcinoma in situ of the cervix No systemic disease that would preclude therapy No psychiatric or addictive disorder that would preclude informed consent Geographically accessible for follow-up Not pregnant
PRIOR CONCURRENT THERAPY: No prior therapy for breast cancer No prior anthracyclines for any malignancy No concurrent sex hormones (e.g., birth control pills or ovarian replacement therapy)
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
Responsible Party
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NSABP Foundation, Inc.
Principal Investigators
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Harry D. Bear, MD, PhD
Role: STUDY_CHAIR
Massey Cancer Center
Locations
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Huntsville Hospital System
Huntsville, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Saint Mary Medical Center - Long Beach
Long Beach, California, United States
Beckman Research Institute, City of Hope
Los Angeles, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States
Catholic Healthcare West - Westbay Region
San Francisco, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States
University of Colorado Cancer Center
Denver, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
George Washington University Cancer Center
Washington D.C., District of Columbia, United States
Halifax Medical Center
Daytona Beach, Florida, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Good Samaritan Medical Center
West Palm Beach, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Medical College of Georgia Comprehensive 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
Illinois Masonic Medical Center
Chicago, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Rockford Clinic
Rockford, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
Norton Healthcare System
Louisville, Kentucky, United States
Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
National Naval Medical Center
Bethesda, Maryland, United States
Regional Cancer Therapy Center - Frederick
Frederick, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Lahey Clinic - Burlington
Burlington, Massachusetts, United States
Berkshire Medical Center
Pittsfield, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Providence Hospital - Southfield
Southfield, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University School of Medicine
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Methodist Cancer Center - 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
Cooper Cancer Institute
Camden, New Jersey, United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Akron City Hospital
Akron, Ohio, United States
Aultman Cancer Center
Canton, Ohio, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, United States
South Pointe Hospital
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Sooner State
Tulsa, Oklahoma, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
St. Luke's Network - Bethlehem
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Kent County Memorial Hospital - Rhode Island
Warwick, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, 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
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Medical Group of Texas
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, 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
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, United States
Vermont Cancer Center
Burlington, Vermont, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Eastern Virginia Medical School
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
Charleston, West Virginia, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
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-Sacrament, Quebec
Québec, Quebec, Canada
L'Hopital Laval
Ste-Foy, Quebec, Canada
Countries
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References
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Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235.
Soran A, Nesbitt L, Mamounas EP, Lembersky B, Bryant J, Anderson S, Brown A, Passarello M. Centralized medical monitoring in phase III clinical trials: the National Surgical Adjuvant Breast and Bowel Project (NSABP) experience. Clin Trials. 2006;3(5):478-85. doi: 10.1177/1740774506070747.
Heys SD, Sarkar T, Hutcheon AW. Primary docetaxel chemotherapy in patients with breast cancer: impact on response and survival. Breast Cancer Res Treat. 2005 Mar;90(2):169-85. doi: 10.1007/s10549-004-1001-0.
Bear HD, Anderson S, Smith RE, Geyer CE Jr, Mamounas EP, Fisher B, Brown AM, Robidoux A, Margolese R, Kahlenberg MS, Paik S, Soran A, Wickerham DL, Wolmark N. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006 May 1;24(13):2019-27. doi: 10.1200/JCO.2005.04.1665. Epub 2006 Apr 10.
Julian T, Anderson S, Fourchotte V, et al.: Is invasive lobular breast cancer a prognostic factor for neoadjuvant chemotherapy response and long term outcomes? [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-3065, S146, 2006.
Mamounas EP, Brown A, Anderson S, Smith R, Julian T, Miller B, Bear HD, Caldwell CB, Walker AP, Mikkelson WM, Stauffer JS, Robidoux A, Theoret H, Soran A, Fisher B, Wickerham DL, Wolmark N. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005 Apr 20;23(12):2694-702. doi: 10.1200/JCO.2005.05.188.
Bear HD, Anderson S, Smith RE, et al.: A randomized trial comparing preoperative (preop) doxorubicin/cyclophosphamide (AC) to preop AC followed by preop docetaxel (T) and to preop AC followed by postoperative (postop) T in patients (pts) with operable carcinoma of the breast: results of NSABP B-27. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-26, 2004.
Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.
Mamounas EP, Brown A, Smith R, et al.: Accuracy of sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: updated results from NSABP B-27. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-140, 2002.
Other Identifiers
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CDR0000064521
Identifier Type: -
Identifier Source: secondary_id
NSABP B-27
Identifier Type: -
Identifier Source: org_study_id
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