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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 whether combination chemotherapy is more
effective with or without filgrastim in treating breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining doxorubicin,
cyclophosphamide, and paclitaxel with or without filgrastim in treating women who have
inflammatory or locally advanced breast cancer.
Active, not recruiting
Ages:0 and older
DISEASE CHARACTERISTICS: - Histologically confirmed inflammatory or locally advanced breast cancer - Stage IIB (T3, N0, M0), IIIA (T3, N1-2, M0 or T0-2, N2, M0), or IIIB (T4, any N, M0 or any T, N3, M0) - Unresectable or otherwise appropriate for neoadjuvant therapy - Confirmed by core needle or incisional biopsy - Punch biopsy allowed if invasive disease is documented - No distant metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Not specified Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - SGOT or SGPT no greater than 2 times ULN Renal: - Creatinine no greater than ULN Cardiovascular: - No congestive heart failure or angina pectoris - LVEF greater than lower limit of normal Other: - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - HIV negative - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for breast cancer Endocrine therapy: - No prior hormonal therapy for breast cancer Radiotherapy: - No prior radiotherapy for breast cancer Surgery: - No prior definitive surgery for breast cancer Other: - No other concurrent anticancer therapy
Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT00016406
Not Accepting Healthy Volunteers