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

Inclusion Criteria

• •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