DISEASE CHARACTERISTICS:

• Diagnosis of stage IV breast cancer
• Unidimensionally measurable disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Female or male
• Life expectancy ≥ 4 months
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Creatinine ≤ 2.5 mg/dL
• AST and ALT ≤ 2 times the upper limit of normal (ULN)*
• Alkaline phosphatase ≤ 2 times ULN*
• Bilirubin ≤ 2 times ULN*
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• Negative pregnancy test
• No history of hypersensitivity attributed to doxorubicin hydrochloride or components of pegylated doxorubicin HCL liposome
• Ejection fraction ≥ 50% by MUGA or 2-dimensionally EKG
• No prior New York Heart Association class II-IV cardiac disease OR clinical evidence of congestive heart failure
• No other life-threatening diseases
• No mental illness

• No other malignancy except any of the following:

  • Synchronous ipsilateral breast cancer of the same subtype (hormone receptors, HER-2/neu)
  • Adequately treated basal cell or squamous cell skin cancer
  • Carcinoma in situ of the cervix
  • Stage I or II cancer from which the patient has been disease free for ≥ 5 years

• No HER2-neu positivity with cardiac disease that would preclude the use of pegylated doxorubicin HCl liposome or trastuzumab (Herceptin®) including the following:

  • Active cardiac disease
  • Angina pectoris requiring antianginal medication
  • Cardiac arrhythmia requiring medication
  • Severe conduction abnormality
  • Clinically significant valvular disease
  • Cardiomegaly on chest x-ray
  • Ventricular hypertrophy on EKG
  • Uncontrolled hypertension, (diastolic BP > 100 mm Hg or systolic BP > 200 mm hg)
  • Clinically significant pericardial effusion
  • History of myocardial infarction documented as a clinical diagnosis by EKG or any other test
  • History of documented congestive heart failure
  • History of documented cardiomyopathy
  • History of documented arrhythmia or cardiac valvular disease requiring medication or is medically significant
• No anthracycline resistant disease NOTE: * ≤ 3 times ULN in the presence of liver metastases

PRIOR CONCURRENT THERAPY:

• No prior treatment with doxorubicin hydrochloride or epirubicin hydrochloride unless all of the following criteria are met:

  • Total cumulative dose does not exceed 360 mg/m² for doxorubicin hydrochloride
  • Total cumulative dose does not exceed 540 mg/m² for epirubicin hydrochloride
  • Disease-free interval from discontinuation of adjuvant treatment to diagnosis of metastatic disease is ≥ 12-18 months
  • At least 12 months since prior exposure to anthracyclines
• No current use of digitalis or beta blockers for CHF