Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed invasive ductal or lobular adenocarcinoma of the breast
• * Metastatic disease as confirmed by ≥ 1 of the following:
• * Histology or cytology
• * Radiology
• * Elevated CA 15-3 levels
• No HER2/neu overexpression by IHC or FISH
• Measurable (≥ 10 mm) or evaluable disease
• * Bone lesions or isolated pleural effusion allowed
• Hormone receptor status not specified
• PATIENT CHARACTERISTICS:
• Postmenopausal
• Life expectancy \> 3 months
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Alkaline phosphatase ≤ 5 times ULN
• Bilirubin ≤ 2 times ULN
• Creatinine clearance ≥ 30 mL/min
• LVEF ≥ 50%
• No congestive heart failure or other uncontrolled cardiac disease
• No other malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix, urothelial in situ carcinoma, or basal cell cancer
• No prior hypersensitivity to anthracyclines
• No psychological, familial, social, or geographical reason that would preclude study follow-up
• No serious illness or physical or mental condition resulting in a permanent disability that may preclude successful treatment
• PRIOR CONCURRENT THERAPY:
• No prior chemotherapy for metastatic disease
• Prior adjuvant chemotherapy allowed
• * No development of metastatic disease within 6 months after completion of adjuvant anthracycline-based chemotherapy
• No more than 300 mg/m² of prior doxorubicin hydrochloride or 600 mg/m² of prior epirubicin hydrochloride in the adjuvant setting
• More than 30 days since prior participation in another clinical trial