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

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