Breast Cancer Clinical Trial

Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven invasive adenocarcinoma of the breast Fine-needle aspiration is acceptable Core or Tru-cut biopsies are preferable No more than 63 days between initial diagnosis and randomization Tumor palpable on clinical exam and confined to the breast and ipsilateral axilla If clinically negative axillary nodes (N0): primary tumor greater than 1 cm (T1c-T3) If clinically positive axillary nodes (N1): any size primary tumor (T1-3) No N2 disease, i.e., ipsilateral nodes clinically fixed to one another or to other structures No skeletal pain unless: Bone scan and/or roentgenologic exam negative for metastatic disease Suspicious findings confirmed as benign by x-ray, MRI, or biopsy No ulceration, erythema, skin infiltration (complete fixation), or peau d'orange, or skin edema of any magnitude Tethering or dimpling of skin or nipple inversion allowed No bilateral malignancy Suspicious contralateral mass proven benign on biopsy allowed None of the following unless proven benign on biopsy: Suspicious palpable nodes in contralateral axilla Palpable supraclavicular or infraclavicular nodes Hormone receptor status: Any status

PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: At least 10 years (exclusive of cancer diagnosis) Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT normal Alkaline phosphatase normal Renal: Creatinine normal Cardiovascular: No active cardiac disease that would preclude doxorubicin, e.g.: Documented myocardial infarction History of congestive heart failure Angina pectoris requiring medication Valvular disease with documented cardiac function compromise Arrhythmia associated with heart failure or cardiac dysfunction Poorly controlled hypertension, i.e., diastolic blood pressure greater than 100 mm Hg Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG unless left ventricular ejection fraction at least 45% by MUGA Other: No other malignancy within the past 10 years except: Segmentally resected lobular carcinoma in situ of the ipsilateral or contralateral breast Effectively treated nonmelanomatous skin cancer Surgically treated carcinoma in situ of the cervix No systemic disease that would preclude therapy No psychiatric or addictive disorder that would preclude informed consent Geographically accessible for follow-up Not pregnant

PRIOR CONCURRENT THERAPY: No prior therapy for breast cancer No prior anthracyclines for any malignancy No concurrent sex hormones (e.g., birth control pills or ovarian replacement therapy)

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

2411

Study ID:

NCT00002707

Recruitment Status:

Completed

Sponsor:

NSABP Foundation Inc

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There are 142 Locations for this study

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Huntsville Hospital System
Huntsville Alabama, 35801, United States
CCOP - Greater Phoenix
Phoenix Arizona, 85006, United States
Sutter Health Western Division Cancer Research Group
Greenbrae California, 94904, United States
Loma Linda University Medical Center
Loma Linda California, 92354, United States
Saint Mary Medical Center - Long Beach
Long Beach California, 90813, United States
Beckman Research Institute, City of Hope
Los Angeles California, 91010, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Comprehensive Cancer Centers of the Desert
Palm Springs California, 92262, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego California, 92120, United States
Catholic Healthcare West - Westbay Region
San Francisco California, 94107, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa California, 95403, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo California, 94589, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver Colorado, 80209, United States
University of Colorado Cancer Center
Denver Colorado, 80262, United States
University of Connecticut Health Center
Farmington Connecticut, 06360, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
George Washington University Cancer Center
Washington District of Columbia, 20037, United States
Halifax Medical Center
Daytona Beach Florida, 32114, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Sylvester Cancer Center, University of Miami
Miami Florida, 33136, United States
Good Samaritan Medical Center
West Palm Beach Florida, 33401, United States
Winship Cancer Institute
Atlanta Georgia, 30322, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
Medical College of Georgia Comprehensive Cancer Center
Augusta Georgia, 30912, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon Georgia, 30905, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
North Idaho Cancer Center
Coeur d'Alene Idaho, 83814, United States
Illinois Masonic Medical Center
Chicago Illinois, 60657, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61602, United States
Rockford Clinic
Rockford Illinois, 61103, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
St. Vincent Hospital and Health Care Center
Indianapolis Indiana, 46260, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington Kentucky, 40536, United States
Norton Healthcare System
Louisville Kentucky, 40202, United States
Louisiana State University Medical Center - New Orleans
New Orleans Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Franklin Square Hospital Center
Baltimore Maryland, 21237, United States
National Naval Medical Center
Bethesda Maryland, 20889, United States
Regional Cancer Therapy Center - Frederick
Frederick Maryland, 21701, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Lahey Clinic - Burlington
Burlington Massachusetts, 01805, United States
Berkshire Medical Center
Pittsfield Massachusetts, 01201, United States
Baystate Medical Center
Springfield Massachusetts, 01199, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Michigan State University
East Lansing Michigan, 48824, United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids Michigan, 49503, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
Providence Hospital - Southfield
Southfield Michigan, 48075, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Ellis Fischel Cancer Center - Columbia
Columbia Missouri, 65203, United States
St. Louis University School of Medicine
Saint Louis Missouri, 63104, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Methodist Cancer Center - Omaha
Omaha Nebraska, 68114, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68131, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Cooper Cancer Institute
Camden New Jersey, 08103, United States
Trinitas Hospital - Jersey Street Campus
Elizabeth New Jersey, 07201, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Cancer Institute of New Jersey at Hamilton
Hamilton New Jersey, 08690, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
University of Medicine and Dentistry of New Jersey
Newark New Jersey, 07103, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
Overlook Hospital
Summit New Jersey, 07902, United States
University of New Mexico Cancer Research & Treatment Center
Albuquerque New Mexico, 87131, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York, 13210, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
East Carolina University School of Medicine
Greenville North Carolina, 27858, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Akron City Hospital
Akron Ohio, 44309, United States
Aultman Cancer Center
Canton Ohio, 44710, United States
Barrett Cancer Center, The University Hospital
Cincinnati Ohio, 45219, United States
Jewish Hospital of Cincinnati, Inc.
Cincinnati Ohio, 45236, United States
South Pointe Hospital
Cleveland Ohio, 44122, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
CCOP - Dayton
Kettering Ohio, 45429, United States
CCOP - Sooner State
Tulsa Oklahoma, 74136, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland Oregon, 97201, United States
CCOP - Columbia River Program
Portland Oregon, 97213, United States
Lehigh Valley Hospital
Allentown Pennsylvania, 18105, United States
St. Luke's Network - Bethlehem
Bethlehem Pennsylvania, 18015, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15213, United States
Mercy Hospital Cancer Center - Scranton
Scranton Pennsylvania, 18501, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
York Hospital
York Pennsylvania, 17315, United States
Kent County Memorial Hospital - Rhode Island
Warwick Rhode Island, 02886, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57105, United States
CCOP - Baptist Cancer Institute
Memphis Tennessee, 38117, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75235, United States
Medical Group of Texas
Dallas Texas, 75243, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Utah Valley Regional Medical Center - Provo
Provo Utah, 84604, United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington Vermont, 05201, United States
Vermont Cancer Center
Burlington Vermont, 05401, United States
Virginia Oncology Associates
Newport News Virginia, 23606, United States
Eastern Virginia Medical School
Norfolk Virginia, 23507, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States
CCOP - Virginia Mason Research Center
Seattle Washington, 98101, United States
Puget Sound Oncology Consortium
Seattle Washington, 98109, United States
CCOP - Northwest
Tacoma Washington, 98405, United States
David Lee Cancer Center
Charleston West Virginia, 25304, United States
West Virginia University Hospitals
Morgantown West Virginia, 26506, United States
Camden-Clark Memorial Hospital
Parkersburg West Virginia, 26102, United States
St. Vincent Hospital
Green Bay Wisconsin, 54307, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield Wisconsin, 54449, United States
St. Luke's Medical Center
Milwaukee Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Tom Baker Cancer Center - Calgary
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Credit Valley Hospital
Mississauga Ontario, L5M 2, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal Quebec, H2L-4, Canada
Royal Victoria Hospital - Montreal
Montreal Quebec, H3A 1, Canada
Montreal General Hospital
Montreal Quebec, H3G 1, Canada
Jewish General Hospital - Montreal
Montreal Quebec, H3T 1, Canada
St. Mary's Hospital Center
Montreal Quebec, H3T 1, Canada
Hopital du Saint-Sacrament, Quebec
Quebec City Quebec, G1S 4, Canada
L'Hopital Laval
Ste-Foy Quebec, G1V 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

2411

Study ID:

NCT00002707

Recruitment Status:

Completed

Sponsor:


NSABP Foundation Inc

How clear is this clinincal trial information?

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