Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically proven progressive or recurrent metastatic breast cancer
• Bidimensionally measurable disease with at least one target lesion
• * If previously irradiated lesions:
• * No preirradiated only lesions
• * Clear progression prior to study
• * New lesions in a previously irradiated region allowed
• Refusal of or medical contraindication to standard anthracycline containing regimen
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age:
• Any age
• Sex:
• Female
• Menopausal status:
• Not specified
• Performance status:
• ECOG 0-2
• Life expectancy:
• Not specified
• Hematopoietic:
• Neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic:
• Bilirubin normal
• Transaminases less than 2 times upper limit of normal
• Renal:
• Creatinine normal
• Cardiovascular:
• Left ventricular ejection fraction normal by echocardiography or MUGA scan
• No significant cardiac history including:
• * Clinically significant atrial or ventricular arrhythmias requiring treatment
• * Medically controlled congestive heart failure
• * Significant angina or clinically and/or electrocardiographically documented myocardial infarction within the past year
• * Clinically significant valvular disease
• Other:
• No other prior or concurrent malignancy within the past 5 years except contralateral breast cancer, or adequately treated basal cell skin cancer or carcinoma in situ of the cervix
• No psychological, familial, sociological, or geographical condition that would preclude study
• Not pregnant or nursing
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Not specified
• Chemotherapy:
• See Disease Characteristics
• Prior adjuvant chemotherapy allowed if total doxorubicin dose is no greater than 300 mg/m2, total epirubicin dose is no greater than 450 mg/m\^2, and total mitoxantrone dose is no greater than 75 mg/m\^2
• No greater than one regimen of prior chemotherapy for metastatic disease
• No prior anthracyclines for metastatic disease
• No other concurrent cytotoxic therapy
• Endocrine therapy:
• No concurrent hormonal therapy
• At least 4 weeks since prior progestins, estrogens, or androgens
• Radiotherapy:
• See Disease Characteristics
• Concurrent palliative radiotherapy allowed if sole target lesion is outside irradiated field
• Surgery:
• Not specified
• Other:
• Concurrent bisphosphonates for metastatic bone disease and hypercalcemia secondary to malignancy allowed if bony lesions not only target lesion
• No other concurrent investigational therapy