Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00002707
- Lead Sponsor
- NSABP Foundation Inc
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if chemotherapy given before surgery is more effective with or without docetaxel given before or after surgery for breast cancer.
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.
- Detailed Description
OBJECTIVES: I. Compare overall and disease-free survival in patients with operable adenocarcinoma of the breast treated with 4 courses of preoperative doxorubicin and cyclophosphamide (AC) alone vs 4 courses of preoperative or postoperative docetaxel (TXT) following 4 courses of preoperative AC. II. Evaluate whether the addition of preoperative TXT to preoperative AC results in improved rates of clinical and pathologic locoregional tumor response. III. Assess whether the addition of preoperative TXT to preoperative AC results in improved rates of breast conservation. IV. Assess whether postoperative TXT improves disease-free and overall survival in patients who receive preoperative AC, especially in certain subgroups of patients (e.g., those with pathologically positive nodes).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2411
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Docetaxel doxorubicin and cyclophosphamide plus Taxotere prior to surgery plus tamoxifen Group 2 Doxorubicin doxorubicin and cyclophosphamide plus Taxotere prior to surgery plus tamoxifen Group 3 Doxorubicin doxorubicin and cyclophosphamide followed by surgery followed by taxotere plus tamoxifen Group 1 Cyclophosphamide doxorubicin and cyclophosphamide plus tamoxifen Group 2 Cyclophosphamide doxorubicin and cyclophosphamide plus Taxotere prior to surgery plus tamoxifen Group 2 Tamoxifen doxorubicin and cyclophosphamide plus Taxotere prior to surgery plus tamoxifen Group 3 Cyclophosphamide doxorubicin and cyclophosphamide followed by surgery followed by taxotere plus tamoxifen Group 3 Docetaxel doxorubicin and cyclophosphamide followed by surgery followed by taxotere plus tamoxifen Group 3 Tamoxifen doxorubicin and cyclophosphamide followed by surgery followed by taxotere plus tamoxifen Group 1 Tamoxifen doxorubicin and cyclophosphamide plus tamoxifen Group 1 Doxorubicin doxorubicin and cyclophosphamide plus tamoxifen
- Primary Outcome Measures
Name Time Method Determine if 4 cycle of pre-op or post-op Taxotere given after 4 cycles of pre-op AC will more effectively prolong survival (S) than does 4 cycles of pre-op AC alone. Time from randomization to death from any cause.
- Secondary Outcome Measures
Name Time Method Prolonging disease-free survival (DFS). Time from randomization to first related event of inoperable disease; residual disease following surgery; local, regional or distant recurrence; second primary cancer; death from any cause other than cancer. Clinical loco-regional tumor response to preoperative chemotherapy. 3-4 weeks after the last cycle of pre-op chemotherapy. Pathologic loco-regional tumor response to pre-op chemotherapy. At time of surgery. Breast conservation assessment. Assessed following surgery. Evaluate if post-op Taxotere is of benefit in patients who received pre-op AC and, if so, whether it is of benefit in certain subgroups of patients. DFS and S will be assessed in patient subgroups.
Trial Locations
- Locations (145)
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Illinois Masonic Medical Center
🇺🇸Chicago, Illinois, United States
South Pointe Hospital
🇺🇸Cleveland, Ohio, United States
Puget Sound Oncology Consortium
🇺🇸Seattle, Washington, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Medical Group of Texas
🇺🇸Dallas, Texas, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Royal Victoria Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
L'Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Kent County Memorial Hospital - Rhode Island
🇺🇸Warwick, Rhode Island, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Virginia Oncology Associates
🇺🇸Newport News, Virginia, United States
Jewish General Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
David Lee Cancer Center
🇺🇸Charleston, West Virginia, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
St. Vincent Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
Kaiser Permanente-Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Jewish Hospital of Cincinnati, Inc.
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Oregon Cancer Center at Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
St. Mary's Hospital Center
🇨🇦Montreal, Quebec, Canada
Hopital du Saint-Sacrament, Quebec
🇨🇦Quebec City, Quebec, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
National Naval Medical Center
🇺🇸Bethesda, Maryland, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Methodist Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
Sutter Health Western Division Cancer Research Group
🇺🇸Greenbrae, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
Saint Mary Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Comprehensive Cancer Centers of the Desert
🇺🇸Palm Springs, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Catholic Healthcare West - Westbay Region
🇺🇸San Francisco, California, United States
Halifax Medical Center
🇺🇸Daytona Beach, Florida, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Baptist Regional Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
George Washington University Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Good Samaritan Medical Center
🇺🇸West Palm Beach, Florida, United States
Medical College of Georgia Comprehensive Cancer Center
🇺🇸Augusta, Georgia, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
North Idaho Cancer Center
🇺🇸Coeur d'Alene, Idaho, United States
Rockford Clinic
🇺🇸Rockford, Illinois, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Lucille Parker Markey Cancer Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Regional Cancer Therapy Center - Frederick
🇺🇸Frederick, Maryland, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Berkshire Medical Center
🇺🇸Pittsfield, Massachusetts, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Lahey Clinic - Burlington
🇺🇸Burlington, Massachusetts, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
St. Louis University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cooper Cancer Institute
🇺🇸Camden, New Jersey, United States
Trinitas Hospital - Jersey Street Campus
🇺🇸Elizabeth, 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
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
University of New Mexico Cancer Research & Treatment Center
🇺🇸Albuquerque, New Mexico, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Aultman Cancer Center
🇺🇸Canton, Ohio, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, 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
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
St. Luke's Network - Bethlehem
🇺🇸Bethlehem, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
🇺🇸Scranton, Pennsylvania, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - Southwestern Vermont Regional Cancer Center
🇺🇸Bennington, Vermont, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, 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
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, 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
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States