Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT00003352
First received: November 1, 1999
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: Taxotere
Drug: Adriamycin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study in Patients With Metastatic or Locally Advanced Breast Cancer to Evaluate the Worth of the Combination of Adriamycin (Doxorubicin), Taxotere (Docetaxel), and Cyclophosphamide (ATC)

Resource links provided by NLM:


Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Primary Outcome Measures:
  • Best over-all tumor response that occurs during 6 cycles of chemotherapy [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Time to first response [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Completion of at least four cycles of chemotherapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: June 1998
Study Completion Date: December 2002
Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cyclophosphamide
    600 mg/m2, IV, every 3 weeks
    Drug: Taxotere
    60 mg/m2, IV, every 3 weeks
    Other Name: docetaxel
    Drug: Adriamycin
    60 mg/m2, IV, every 3 weeks
    Other Name: doxorubicin hydrochloride
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic (stage IV) or locally advanced (stage IIIB) adenocarcinoma of the breast. Bidimensionally measurable disease. No active central nervous system (CNS) metastases. Brain metastases must be controlled for at least 3 months and have other sites of measurable disease. No carcinomatous meningitis. No lymphangitic lung metastases as the only site of metastatic disease. Hormone receptor status: Any estrogen or progesterone receptor status.

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003352

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Locations
United States, Alabama
Baptist Medical Center - Birmingham
Birmingham, Alabama, United States, 35213
Huntsville Hospital System
Huntsville, Alabama, United States, 35801
MBCCOP - University of South Alabama
Mobile, Alabama, United States, 36688
United States, Arizona
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Beckman Research Institute, City of Hope
Duarte, California, United States, 91010
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Scripps Clinic and Research Foundation - La Jolla
La Jolla, California, United States, 92037
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Saint Mary Medical Center - Long Beach
Long Beach, California, United States, 90813-0887
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Naval Medical Center - Oakland
Oakland, California, United States, 94627-5000
Veterans Affairs Satellite Clinic - Sacramento
Sacramento, California, United States, 95820
Sutter Cancer Center
Sacramento, California, United States, 95816
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
United States, Colorado
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States, 80209-5031
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, Florida
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Ocala Oncology Center
Ocala, Florida, United States, 34474
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Georgia
Winship Cancer Center
Atlanta, Georgia, United States, 30322
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, United States, 30912-4000
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
CCOP - Evanston
Evanston, Illinois, United States, 60201
Highland Park Hospital
Highland Park, Illinois, United States, 60035-2497
West Suburban Hospital Medical Center
Oak Park, Illinois, United States, 60302
Rockford Clinic
Rockford, Illinois, United States, 61103
CCOP - Central Illinois
Springfield, Illinois, United States, 62526
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Community Hospitals of Indianapolis - Regional Cancer Center
Indianapolis, Indiana, United States, 46219
Methodist Cancer Center - Indianapolis
Indianapolis, Indiana, United States, 46206-1367
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 10309-1016
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Kentucky
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0093
Norton Healthcare System
Louisville, Kentucky, United States, 40202-5070
Baptist Hospital East - Louisville
Louisville, Kentucky, United States, 40207
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
National Naval Medical Center
Bethesda, Maryland, United States, 20889-5000
Regional Cancer Therapy Center - Frederick
Frederick, Maryland, United States, 21701
United States, Massachusetts
New England Medical Center Hospital
Boston, Massachusetts, United States, 02111
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Clinic - Burlington
Burlington, Massachusetts, United States, 01805
Berkshire Medical Center
Pittsfield, Massachusetts, United States, 01201
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
Michigan State University
East Lansing, Michigan, United States, 48824
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
Providence Hospital - Southfield
Southfield, Michigan, United States, 48075-9975
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Mississippi
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
St. Louis University School of Medicine
Saint Louis, Missouri, United States, 63104
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
Methodist Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New Mexico
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany Regional Cancer Center
Albany, New York, United States, 12208
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
Genesee Hospital - Rochester
Rochester, New York, United States, 14607
Staten Island University Hospital
Staten Island, New York, United States, 10305
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13210
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States, 58102
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, United States, 45236
Mount Sinai Medical Center - Cleveland
Cleveland, Ohio, United States, 44122
Meridia South Pointe Hospital
Cleveland, Ohio, United States, 44122
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
CCOP - Columbus
Columbus, Ohio, United States, 43206
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Kettering, Ohio, United States, 45429
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Oklahoma
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105-1556
St. Luke's Network - Bethlehem
Bethlehem, Pennsylvania, United States, 18015
Penn State Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States, 15240
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Kent County Memorial Hospital - Rhode Island
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57105-1080
United States, Tennessee
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States, 38117
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
Medical Group of Texas
Dallas, Texas, United States, 75243
Kelsey Seybold Clinic
Houston, Texas, United States, 77025
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States, 78236-5300
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284
MBCCOP - South Texas Pediatric
San Antonio, Texas, United States, 78284-7810
University of Texas Health Center at Tyler
Tyler, Texas, United States, 75710
United States, Utah
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Virginia
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
Veterans Affairs Medical Center - Salem
Salem, Virginia, United States, 24153
United States, Washington
Puget Sound Oncology Consortium
Seattle, Washington, United States, 98109
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
United States, West Virginia
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
United States, Wisconsin
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Manitoba Cancer Treatment and Research Foundation
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2W-W1T8
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada, H3A 1A1
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospital - Montreal
Montreal, Quebec, Canada, H3T 1E2
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan, Puerto Rico, 00927-5800
MBCCOP - San Juan
San Juan, Puerto Rico, 00927-5800
Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier: NCT00003352     History of Changes
Other Study ID Numbers: NSABP BP-58, NSABP-BP-58
Study First Received: November 1, 1999
Last Updated: December 10, 2012
Health Authority: United States: Federal Government

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
stage IV breast cancer
recurrent breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 29, 2014