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

NCT00003352 | Completed Phase 2 DMC

• 2 other identifiers: NSABP BP-58NSABP-BP-58
• Study Type: interventional
• Target: 89
• Locations: 3 countries
• Sites: 166

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (1)

• Best over-all tumor response that occurs during 6 cycles of chemotherapy

  18 weeks

Secondary Outcomes (6)

• 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

Interventions

cyclophosphamide DRUG

600 mg/m2, IV, every 3 weeks

Taxotere DRUG

60 mg/m2, IV, every 3 weeks

Also known as: docetaxel

Adriamycin DRUG

60 mg/m2, IV, every 3 weeks

Also known as: doxorubicin hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• National Cancer Institute (NCI): collaborator

Study Sites (166)

Baptist Medical Center - Birmingham

Birmingham, Alabama, 35213, United States

Location

Huntsville Hospital System

Huntsville, Alabama, 35801, United States

Location

MBCCOP - University of South Alabama

Mobile, Alabama, 36688, United States

Location

CCOP - Greater Phoenix

Phoenix, Arizona, 85006-2726, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Beckman Research Institute, City of Hope

Duarte, California, 91010, United States

Location

Scripps Clinic and Research Foundation - La Jolla

La Jolla, California, 92037, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Saint Mary Medical Center - Long Beach

Long Beach, California, 90813-0887, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Naval Medical Center - Oakland

Oakland, California, 94627-5000, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

Veterans Affairs Satellite Clinic - Sacramento

Sacramento, California, 95820, United States

Location

Naval Medical Center - San Diego

San Diego, California, 92134-3202, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

CCOP - Colorado Cancer Research Program, Inc.

Denver, Colorado, 80209-5031, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

Baptist Regional Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Winship Cancer Center

Atlanta, Georgia, 30322, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Medical College of Georgia Comprehensive Cancer Center

Augusta, Georgia, 30912-4000, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

Highland Park Hospital

Highland Park, Illinois, 60035-2497, United States

Location

West Suburban Hospital Medical Center

Oak Park, Illinois, 60302, United States

Location

Rockford Clinic

Rockford, Illinois, 61103, United States

Location

CCOP - Central Illinois

Springfield, Illinois, 62526, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Methodist Cancer Center - Indianapolis

Indianapolis, Indiana, 46206-1367, United States

Location

Community Hospitals of Indianapolis - Regional Cancer Center

Indianapolis, Indiana, 46219, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 10309-1016, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

Lucille Parker Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Norton Healthcare System

Louisville, Kentucky, 40202-5070, United States

Location

Baptist Hospital East - Louisville

Louisville, Kentucky, 40207, United States

Location

Louisiana State University Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

National Naval Medical Center

Bethesda, Maryland, 20889-5000, United States

Location

Regional Cancer Therapy Center - Frederick

Frederick, Maryland, 21701, United States

Location

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Lahey Clinic - Burlington

Burlington, Massachusetts, 01805, United States

Location

Berkshire Medical Center

Pittsfield, Massachusetts, 01201, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

CCOP - Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Providence Hospital - Southfield

Southfield, Michigan, 48075-9975, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

St. Louis University School of Medicine

St Louis, Missouri, 63104, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Methodist Cancer Center - Omaha

Omaha, Nebraska, 68114, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

University of New Mexico Cancer Research & Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

Albany Regional Cancer Center

Albany, New York, 12208, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

Genesee Hospital - Rochester

Rochester, New York, 14607, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13210, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

Veterans Affairs Medical Center - Fargo

Fargo, North Dakota, 58102, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Akron City Hospital

Akron, Ohio, 44309, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219, United States

Location

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Jewish Hospital of Cincinnati, Inc.

Cincinnati, Ohio, 45236, United States

Location

Meridia South Pointe Hospital

Cleveland, Ohio, 44122, United States

Location

Mount Sinai Medical Center - Cleveland

Cleveland, Ohio, 44122, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center

Tulsa, Oklahoma, 74136, United States

Location

Oregon Cancer Center at Oregon Health Sciences University

Portland, Oregon, 97201-3098, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97213, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105-1556, United States

Location

St. Luke's Network - Bethlehem

Bethlehem, Pennsylvania, 18015, United States

Location

Penn State Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Veterans Affairs Medical Center - Pittsburgh

Pittsburgh, Pennsylvania, 15240, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Kent County Memorial Hospital - Rhode Island

Warwick, Rhode Island, 02886, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57105-1080, United States

Location

Veterans Affairs Medical Center - Memphis

Memphis, Tennessee, 38104, United States

Location

CCOP - Baptist Cancer Institute

Memphis, Tennessee, 38117, United States

Location

Medical Group of Texas

Dallas, Texas, 75243, United States

Location

Kelsey Seybold Clinic

Houston, Texas, 77025, United States

Location

Wilford Hall - 59th Medical Wing

Lackland Air Force Base, Texas, 78236-5300, United States

Location

MBCCOP - South Texas Pediatric

San Antonio, Texas, 78284-7810, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284, United States

Location

University of Texas Health Center at Tyler

Tyler, Texas, 75710, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Virginia Oncology Associates

Newport News, Virginia, 23606, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Veterans Affairs Medical Center - Richmond

Richmond, Virginia, 23249, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

Location

Veterans Affairs Medical Center - Salem

Salem, Virginia, 24153, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Puget Sound Oncology Consortium

Seattle, Washington, 98109, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Camden-Clark Memorial Hospital

Parkersburg, West Virginia, 26102, United States

Location

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Manitoba Cancer Treatment and Research Foundation

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital - Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2W-W1T8, Canada

Location

Royal Victoria Hospital - Montreal

Montreal, Quebec, H3A 1A1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital - Montreal

Montreal, Quebec, H3T 1E2, Canada

Location

Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

MBCCOP - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Veterans Affairs Medical Center - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 12533263 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Norman Wolmark, MD

  NSABP Foundation Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: June 27, 2003
• Study Start: June 1, 1998
• Primary Completion: September 1, 2000
• Study Completion: December 1, 2002
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

PR (2); US (152); CA (12)