Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00003352
- 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of doxorubicin, cyclophosphamide, and docetaxel in treating women with stage IIIB or stage IV breast cancer.
- Detailed Description
OBJECTIVES: I. Determine the overall response rate to doxorubicin, docetaxel, and cyclophosphamide (ATC) in women with metastatic or locally advanced breast cancer. II. Determine survival, time to first response, time to progression, and duration of response in these patients. III. Evaluate the feasibility of administering ATC for at least 4 courses. IV. Evaluate the toxicity profile of ATC and its effect on cardiac function.
OUTLINE: Patients receive intravenous doxorubicin over 15 minutes on day 0, followed by intravenous cyclophosphamide over 30 minutes. An hour after the end of the doxorubicin infusion, intravenous docetaxel is administered over 1 hour. Patients receive courses every 21 days until disease progression or unacceptable toxic effects are observed. When the maximum dose of doxorubicin is reached, treatment continues with docetaxel and cyclophosphamide. Patients with locally advanced breast cancer receive chemotherapy for at least 2 courses after documented response. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: Approximately 89 patients will be accrued to this study within 14 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 89
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Best over-all tumor response that occurs during 6 cycles of chemotherapy 18 weeks
- Secondary Outcome Measures
Name Time Method Survival 18 weeks Time to first response 18 weeks Time to progression 18 weeks Duration of response 18 weeks Completion of at least four cycles of chemotherapy 12 weeks Toxicity profile 18 weeks
Trial Locations
- Locations (166)
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Illinois Masonic Medical Center
🇺🇸Chicago, Illinois, United States
Meridia South Pointe Hospital
🇺🇸Cleveland, Ohio, United States
Mount Sinai Medical Center - Cleveland
🇺🇸Cleveland, Ohio, United States
Puget Sound Oncology Consortium
🇺🇸Seattle, Washington, United States
Regional Cancer Therapy Center - Frederick
🇺🇸Frederick, Maryland, United States
Kelsey Seybold Clinic
🇺🇸Houston, Texas, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Good Samaritan Hospital - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Jewish Hospital of Cincinnati, Inc.
🇺🇸Cincinnati, Ohio, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Naval Medical Center - Oakland
🇺🇸Oakland, California, United States
Winship Cancer Center
🇺🇸Atlanta, Georgia, United States
Scripps Clinic and Research Foundation - La Jolla
🇺🇸La Jolla, California, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Baptist Regional Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Saint Mary Medical Center - Long Beach
🇺🇸Long Beach, California, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Medical College of Georgia Comprehensive Cancer Center
🇺🇸Augusta, Georgia, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
West Suburban Hospital Medical Center
🇺🇸Oak Park, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Community Hospitals of Indianapolis - Regional Cancer Center
🇺🇸Indianapolis, Indiana, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Lucille Parker Markey Cancer Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
St. Luke's Network - Bethlehem
🇺🇸Bethlehem, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Genesee Hospital - Rochester
🇺🇸Rochester, New York, United States
Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
University of Texas Health Center at Tyler
🇺🇸Tyler, Texas, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
Veterans Affairs Medical Center - Salem
🇺🇸Salem, Virginia, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Penn State Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Medical Group of Texas
🇺🇸Dallas, Texas, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
MBCCOP - South Texas Pediatric
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
Manitoba Cancer Treatment and Research Foundation
🇨🇦Winnipeg, Manitoba, Canada
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Jewish General Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
MBCCOP - San Juan
🇵🇷San Juan, Puerto Rico
Baptist Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Oregon Cancer Center at Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
🇨🇦Quebec City, Quebec, Canada
Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
Methodist Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Kent County Memorial Hospital - Rhode Island
🇺🇸Warwick, Rhode Island, United States
National Naval Medical Center
🇺🇸Bethesda, Maryland, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Highland Park Hospital
🇺🇸Highland Park, Illinois, United States
Rockford Clinic
🇺🇸Rockford, Illinois, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Methodist Cancer Center - Indianapolis
🇺🇸Indianapolis, Indiana, United States
CCOP - Central Illinois
🇺🇸Springfield, Illinois, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Berkshire Medical Center
🇺🇸Pittsfield, Massachusetts, United States
Lahey Clinic - Burlington
🇺🇸Burlington, Massachusetts, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Albany Regional Cancer Center
🇺🇸Albany, New York, United States
University of New Mexico Cancer Research & Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Wilford Hall - 59th Medical Wing
🇺🇸Lackland Air Force Base, Texas, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Virginia Oncology Associates
🇺🇸Newport News, Virginia, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Royal Victoria Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
St. Michael's Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
Veterans Affairs Medical Center - San Juan
🇵🇷San Juan, Puerto Rico
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
St. Louis University School of Medicine
🇺🇸Saint Louis, Missouri, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
🇺🇸Tulsa, Oklahoma, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Veterans Affairs Satellite Clinic - Sacramento
🇺🇸Sacramento, California, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, 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
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Norton Healthcare System
🇺🇸Louisville, Kentucky, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
Louisiana State University Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Veterans Affairs Medical Center - Richmond
🇺🇸Richmond, Virginia, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States