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