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

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