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

Inclusion Criteria

• •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