Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer

DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer

  * Disease must be confined to the breast and axillary nodes without detected masses elsewhere
  * No history of prior ipsilateral or contralateral invasive breast cancer
* Resected disease

  * No more than 16 weeks since last surgery to remove the tumor
  * No known clinical residual locoregional disease
  * Margins must be negative for invasive breast cancer and ductal carcinoma in situ
* No locally advanced, inoperable breast cancer including any of the following:

  * Inflammatory breast cancer
  * Supraclavicular node involvement
  * Enlarged internal mammary nodes unless pathologically negative
* Synchronous bilateral invasive breast cancer (diagnosed in the past 2 months) allowed if all tumors are hormone receptor-negative
* Must not be a candidate for endocrine therapy or standard chemotherapy
* Hormone receptor-negative disease

PATIENT CHARACTERISTICS:

* Female
* Menopausal status: postmenopausal
* ECOG performance status 0-2
* Platelet count ≥ 100,000/mm\^3
* Granulocyte count ≥ 1,500/mm\^3
* WBC ≥ 3,000/mm\^3
* AST and ALT ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin normal
* Creatinine clearance ≥ 50 mL/min
* Creatinine \< 1.35 mg/dL
* No significant malabsorption syndrome or disease affecting gastrointestinal tract function
* No myocardial infarction within the past 6 months
* No pulmonary embolism within the past 6 months
* No deep vein thrombosis within the past 6 months
* No New York Heart Association class III or IV heart disease
* LVEF ≥ 50% by echocardiography, radionucleotide ventriculography, or MUGA
* No evidence of acute ischemia by ECG
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or bladder, or ipsilateral or contralateral breast carcinoma in situ
* No active, uncontrolled infection
* No active hepatitis B or C virus infection
* No other chronic infection
* Patients must not have any of the following "geriatric syndromes":

  * Dementia
  * Delirium
  * Major depression (as diagnosed by a psychiatrist)
  * Recent falls
  * Spontaneous bone fractures
  * Neglect
  * Abuse
* No evidence of medically relevant conduction system abnormalities that would preclude study entry
* No other nonmalignant, uncontrolled systemic diseases, psychiatric illness, or addictive or cognitive disorder that would preclude study participation or compliance

PRIOR CONCURRENT THERAPY:

* At least 4 weeks since prior raloxifene, tamoxifen citrate, or other selective estrogen receptor modulators (SERMs)
* No concurrent recombinant human epoetin alfa or pegfilgrastim
* No prior neoadjuvant or adjuvant therapy for breast cancer except radiotherapy
* Concurrent trastuzumab (Herceptin®) allowed
* No concurrent hormonal replacement therapy
* No other concurrent hormonal therapy (including estrogen, progesterone, androgens, tamoxifen citrate, SERMs, or aromatase inhibitors) except for the following:

  * Steroids for adrenal failure
  * Hormones for non-disease-related conditions (e.g., insulin for diabetes)
  * Intermittent dexamethasone as an antiemetic
* No other concurrent investigational agents
* No concurrent bisphosphonates, except for the treatment of osteoporosis
* For patients who received prior anthracyclines, the following criteria must be met:

  * Cumulative dose ≤ 240 mg/m² for conventional doxorubicin

    * ≤ 140 mg/m² in case of prior doxorubicin and left chest radiotherapy (LCRT)
  * Cumulative dose ≤ 400 mg/m² for epirubicin

    * ≤ 230 mg/m² in case of prior epirubicin and LCRT