Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the breast that is potentially curable
• * T0-4 (dermal involvement on pathology assessment only), N0-2, M0
• * No clinical T4 disease
• Previously treated with one of the following:
• * Total mastectomy and level II axillary node dissection
• * Partial mastectomy and level II axillary node dissection with planned breast radiotherapy after completion of adjuvant chemotherapy regimen\*
• * Patients with a positive sentinel node biopsy must undergo level II axillary node dissection or sufficient nodal sampling
• * If microscopic residual in situ or invasive disease is present at total or partial mastectomy margins, planned radiotherapy must also include a boost to the tumor bed
• No residual tumor in the axilla after dissection
• Axillary node positive
• * Negative nodes allowed if the tumor is ≥ 1 cm and 1 or more of the following criteria defining high-risk node-negative disease are met:
• * Histological grade III or,
• * Estrogen receptor negative or,
• * Lymphatic/vascular invasion
• Hormone receptor status:
• * Estrogen receptor status known
• PATIENT CHARACTERISTICS:
• Age:
• 60 and under
• Sex:
• Female
• Menopausal status:
• Pre- or postmenopausal
• Performance status:
• ECOG 0-2
• Life expectancy:
• At least 5 years
• Hematopoietic:
• WBC ≥ 3,000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hepatic:
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Renal:
• Creatinine ≤ 1.5 times ULN
• Cardiovascular:
• LVEF ≥ limit of normal by MUGA or echocardiogram
• No arrhythmia requiring ongoing treatment
• No congestive heart failure
• No documented coronary artery disease
• Other:
• No other malignancy except:
• * Adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• * Ductal or lobular carcinoma in situ that has been curatively treated by surgery alone
• * Other prior malignancies (except breast cancer) curatively treated more than 5 years prior to study entry
• No serious underlying medical illness or psychiatric or addictive disorder that would preclude study compliance
• No known hypersensitivity to E. coli-derived products, mammalian-cell derived products, or any study agents
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective non-hormonal contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No prior immunotherapy for breast cancer
• No concurrent pegfilgrastim or darbepoetin alfa (Arm II)
• * Allowed on arms 1 and 3 if medically necessary
• Chemotherapy:
• No prior chemotherapy for breast cancer
• Endocrine therapy:
• No prior hormonal therapy for breast cancer
• No concurrent hormone replacement therapy
• No concurrent selective estrogen-receptor modulators (e.g., raloxifene for the treatment or prevention of osteoporosis)
• No concurrent oral contraceptives (i.e., birth control pills)
• No other concurrent aromatase inhibitors
• Radiotherapy:
• See Disease Characteristics
• No prior radiotherapy for breast cancer
• Surgery:
• See Disease Characteristics
• No more than 12 weeks since prior total or partial mastectomy (including re-excision of margins)
• Other:
• At least 30 days since prior investigational drugs
• No other concurrent investigational drugs
• Concurrent bisphosphonates for the treatment or prevention of osteoporosis allowed