Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
NCT ID: NCT00003352
Last Updated: 2012-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
89 participants
INTERVENTIONAL
1998-06-30
2002-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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cyclophosphamide
600 mg/m2, IV, every 3 weeks
Taxotere
60 mg/m2, IV, every 3 weeks
Adriamycin
60 mg/m2, IV, every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over. Sex: Female. Menopausal status: Not specified. Performance status: Eastern Cooperative Oncology Group (ECOG) score range 0-2. Life expectancy: At least 6 months. Hematopoietic: Absolute neutrophil count at least 2,000/mm3. Platelet count at least 100,000/mm3. Hepatic: serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic pyruvic transaminase (SGPT) no greater than 2.5 times upper limit of normal (ULN). Alkaline phosphatase no greater than 5 times ULN. Bilirubin no greater than ULN. No SGOT and/or SGPT greater than 1.5 times ULN if concomitant with alkaline phosphatase greater than 2.5 times ULN. Renal: Calcium no greater than 1.2 times ULN. Creatinine no greater than 1.5 times ULN. Cardiovascular:left ventricular ejection fraction (LVEF) at least institutional lower limit of normal on multiple gated acquisition scan (MUGA) or echocardiogram. No myocardial infarction within 6 months. No angina pectoris requiring antianginal medication. No history of congestive heart failure. No cardiac arrhythmias requiring medication. No vascular disease with documented cardiac function compromise No uncontrolled hypertension (diastolic greater than 100 mm Hg). Other: Not pregnant or nursing. Fertile patients must use effective barrier contraception. No diabetics with fasting blood sugar greater than 200 mg/dL. No peripheral neuropathy greater than grade 1. No psychosis or addictive disorders. No known hypersensitivity to E. coli-derived drugs.
PRIOR CONCURRENT THERAPY: Chemotherapy: No prior chemotherapy for metastatic breast cancer or non-breast cancer. At least 12 months since nontaxane containing adjuvant chemotherapy for primary tumor (in patients with metastatic disease). Prior adjuvant chemotherapy with anthracycline containing regimens allowed (provided total doxorubicin dose did not exceed 240 mg/m2). Endocrine therapy: At least 4 weeks since adjuvant hormone or hormone therapy for metastatic disease (at least 2 weeks for rapidly progressive disease). No concurrent hormonal birth control. Radiotherapy: At least 4 weeks since prior radiotherapy. Prior breast radiotherapy following lumpectomy allowed. No radiotherapy to greater than 30% of bone marrow. No prior left chest wall radiotherapy with anthracycline containing adjuvant chemotherapy. Surgery: Not specified.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
Responsible Party
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Principal Investigators
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Norman Wolmark, MD
Role: PRINCIPAL_INVESTIGATOR
NSABP Foundation Inc
Locations
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Baptist Medical Center - Birmingham
Birmingham, Alabama, United States
Huntsville Hospital System
Huntsville, Alabama, United States
MBCCOP - University of South Alabama
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Beckman Research Institute, City of Hope
Duarte, California, 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
Loma Linda University Medical Center
Loma Linda, California, United States
Saint Mary Medical Center - Long Beach
Long Beach, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Naval Medical Center - Oakland
Oakland, California, United States
Sutter Cancer Center
Sacramento, California, United States
Veterans Affairs Satellite Clinic - Sacramento
Sacramento, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Veterans Affairs Medical Center - San Francisco
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
Hartford Hospital
Hartford, Connecticut, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 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
Ocala Oncology Center
Ocala, Florida, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Winship Cancer Center
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Illinois Masonic Medical Center
Chicago, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
Highland Park Hospital
Highland Park, Illinois, United States
West Suburban Hospital Medical Center
Oak Park, Illinois, United States
Rockford Clinic
Rockford, Illinois, United States
CCOP - Central Illinois
Springfield, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Methodist Cancer Center - Indianapolis
Indianapolis, Indiana, United States
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
Norton Healthcare System
Louisville, Kentucky, United States
Baptist Hospital East - Louisville
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
Veterans Affairs Medical Center - New Orleans
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
New England Medical Center Hospital
Boston, Massachusetts, 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
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
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, 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
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
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 & Treatment Center
Albuquerque, New Mexico, United States
Albany Regional Cancer Center
Albany, New York, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
Genesee Hospital - Rochester
Rochester, New York, United States
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
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
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Akron City Hospital
Akron, Ohio, 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
Meridia South Pointe Hospital
Cleveland, Ohio, United States
Mount Sinai Medical Center - Cleveland
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
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
Penn State Geisinger Medical Center
Danville, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, 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
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States
Medical Group of Texas
Dallas, Texas, United States
Kelsey Seybold Clinic
Houston, Texas, United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States
MBCCOP - South Texas Pediatric
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Texas Health Center at Tyler
Tyler, Texas, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
Veterans Affairs Medical Center - Salem
Salem, 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
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, 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
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Manitoba Cancer Treatment and Research Foundation
Winnipeg, Manitoba, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
Toronto, 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
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Québec, Quebec, Canada
Hopital Laval
Ste-Foy, Quebec, Canada
MBCCOP - San Juan
San Juan, , Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan, , Puerto Rico
Countries
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References
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Smith RE, Anderson SJ, Brown A, Scholnik AP, Desai AM, Kardinal CG, Lembersky BC, Mamounas EP. Phase II trial of doxorubicin/docetaxel/cyclophosphamide for locally advanced and metastatic breast cancer: results from NSABP trial BP-58. Clin Breast Cancer. 2002 Dec;3(5):333-40. doi: 10.3816/CBC.2002.n.036.
Other Identifiers
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NSABP-BP-58
Identifier Type: -
Identifier Source: secondary_id
NSABP BP-58
Identifier Type: -
Identifier Source: org_study_id