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.
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.
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)
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There are 142 Locations for this study
Huntsville Alabama, 35801, United States
Phoenix Arizona, 85006, United States
Greenbrae California, 94904, United States
Loma Linda California, 92354, United States
Long Beach California, 90813, United States
Los Angeles California, 91010, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Palm Springs California, 92262, United States
San Diego California, 92120, United States
San Francisco California, 94107, United States
Santa Rosa California, 95403, United States
Vallejo California, 94589, United States
Denver Colorado, 80209, United States
Denver Colorado, 80262, United States
Farmington Connecticut, 06360, United States
Hartford Connecticut, 06102, United States
Wilmington Delaware, 19899, United States
Washington District of Columbia, 20037, United States
Daytona Beach Florida, 32114, United States
Jacksonville Florida, 32207, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33136, United States
West Palm Beach Florida, 33401, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Augusta Georgia, 30912, United States
Fort Gordon Georgia, 30905, United States
Honolulu Hawaii, 96813, United States
Coeur d'Alene Idaho, 83814, United States
Chicago Illinois, 60657, United States
Evanston Illinois, 60201, United States
Peoria Illinois, 61602, United States
Rockford Illinois, 61103, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46260, United States
South Bend Indiana, 46601, United States
Des Moines Iowa, 50309, United States
Iowa City Iowa, 52242, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Bangor Maine, 04401, United States
Baltimore Maryland, 21237, United States
Bethesda Maryland, 20889, United States
Frederick Maryland, 21701, United States
Boston Massachusetts, 02118, United States
Burlington Massachusetts, 01805, United States
Pittsfield Massachusetts, 01201, United States
Springfield Massachusetts, 01199, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48202, United States
East Lansing Michigan, 48824, United States
Grand Rapids Michigan, 49503, United States
Kalamazoo Michigan, 49007, United States
Southfield Michigan, 48075, United States
Duluth Minnesota, 55805, United States
Minneapolis Minnesota, 55415, United States
Jackson Mississippi, 39216, United States
Columbia Missouri, 65203, United States
Saint Louis Missouri, 63104, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89106, United States
Camden New Jersey, 08103, United States
Elizabeth New Jersey, 07201, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Hamilton New Jersey, 08690, United States
New Brunswick New Jersey, 08901, United States
Newark New Jersey, 07103, United States
Newark New Jersey, 07112, United States
Summit New Jersey, 07902, United States
Albuquerque New Mexico, 87131, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Greenville North Carolina, 27858, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Fargo North Dakota, 58122, United States
Akron Ohio, 44309, United States
Canton Ohio, 44710, United States
Cincinnati Ohio, 45219, United States
Cincinnati Ohio, 45236, United States
Cleveland Ohio, 44122, United States
Columbus Ohio, 43206, United States
Columbus Ohio, 43210, United States
Kettering Ohio, 45429, United States
Tulsa Oklahoma, 74136, United States
Portland Oregon, 97201, United States
Portland Oregon, 97213, United States
Allentown Pennsylvania, 18105, United States
Bethlehem Pennsylvania, 18015, United States
Danville Pennsylvania, 17822, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15213, United States
Scranton Pennsylvania, 18501, United States
Wynnewood Pennsylvania, 19096, United States
York Pennsylvania, 17315, United States
Warwick Rhode Island, 02886, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Sioux Falls South Dakota, 57105, United States
Memphis Tennessee, 38117, United States
Dallas Texas, 75235, United States
Dallas Texas, 75243, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78284, United States
Temple Texas, 76508, United States
Provo Utah, 84604, United States
Bennington Vermont, 05201, United States
Burlington Vermont, 05401, United States
Newport News Virginia, 23606, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98101, United States
Seattle Washington, 98109, United States
Tacoma Washington, 98405, United States
Charleston West Virginia, 25304, United States
Morgantown West Virginia, 26506, United States
Parkersburg West Virginia, 26102, United States
Green Bay Wisconsin, 54307, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Winnipeg Manitoba, R3E 0, Canada
Mississauga Ontario, L5M 2, Canada
Montreal Quebec, H2L-4, Canada
Montreal Quebec, H3A 1, Canada
Montreal Quebec, H3G 1, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H3T 1, Canada
Quebec City Quebec, G1S 4, Canada
Ste-Foy Quebec, G1V 4, Canada
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