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 combining docetaxel, doxorubicin, and cyclophosphamide in treating women who have previously untreated stage III breast cancer.

Condition	Treatment or Intervention	Phase
stage IIIB breast cancer stage IIIA breast cancer	Drug: cyclophosphamide  Drug: docetaxel  Drug: doxorubicin	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the clinical response rate to docetaxel, doxorubicin, and cyclophosphamide as primary therapy in women with stage III breast cancer. II. Determine the pathologic complete response rate to this treatment regimen in this patient population. III. Assess the side effects and toxicity profile of this treatment regimen in these patients.

PROTOCOL OUTLINE: This is an open label, multicenter study. Patients receive doxorubicin IV over 5-10 minutes followed by cyclophosphamide IV over 5-10 minutes and docetaxel IV over 1 hour. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 5 weeks following completion of chemotherapy, operable patients achieving complete or partial response undergo mastectomy, segmental mastectomy, or lumpectomy with nodal dissection. Patients with positive surgical tumor margins may undergo an additional surgical procedure. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed previously untreated, stage III adenocarcinoma of the breast
• At least one bidimensionally and/or unidimensionally measurable lesion
• No evidence of disease outside the breast or chest wall, except for ipsilateral axillary lymph nodes
• Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

• Biologic therapy: No prior immunotherapy for breast cancer
• Chemotherapy: No prior chemotherapy for breast cancer
• Endocrine therapy: No prior hormonal therapy for breast cancer; No concurrent corticosteroids except for chronic methylprednisolone or equivalent for more than 6 months duration at no more than 20 mg/day
• Radiotherapy: Not specified
• Surgery: Not specified
• Other: At least 3 weeks since prior investigational drugs

--Patient Characteristics--

• Age: 18 and over
• Sex: Female
• Menopausal status: Not specified
• Performance status: Karnofsky 60-100%
• Life expectancy: Not specified
• Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than upper limit of normal (ULN); SGOT no greater than 3 times ULN; Alkaline phosphatase no greater than 5 times ULN; No acute hepatitis
• Renal: Creatinine no greater than 1.5 mg/dL; No uncontrolled hypercalcemia
• Cardiovascular: No congestive heart failure; LVEF normal; No angina pectoris; No uncontrolled cardiac arrhythmias; No other significant heart disease; No myocardial infarction within the past year; No superior vena cava syndrome; No deep vein thrombosis requiring anticoagulant therapy
• Neurologic: No dementia; No seizures; No concurrent grade 2 or greater peripheral neuropathy
• Other: No medical instability; No active infection; No gastrointestinal bleeding; No uncontrolled diabetes; No psychological, familial, sociological, or geographical conditions or other circumstances that would preclude study; No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix; No history of hypersensitivity to polysorbate 80; Not pregnant or nursing; Fertile patients must use effective contraception

California
      Stanford University Medical Center, Stanford,  California,  94305-5408,  United States
Illinois
      Monroe Medical Associates, Chicago,  Illinois,  60603,  United States
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States
New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States

Study chairs or principal investigators

William John Gradishar,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067423; NU-98B1; NCI-G99-1643
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004175
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08