Docetaxel in Treating Older Women With Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

  • Metastatic disease
• Measurable disease by CT scan or MRI
• Requires first-line chemotherapy for metastatic disease

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age

• 70 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Meets both of the following criteria:

  • Lawton's Instrumental Activities of Daily Living score ≥ 4
  • Katz's Activities of Daily Living score ≥ 4

Life expectancy

• More than 3 months

Hematopoietic

• Hemoglobin > 10 g/dL
• Neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3

Hepatic

• ALT and AST < 1.5 times normal
• Bilirubin normal
• Alkaline phosphatase < 2.5 times normal

Renal

• Creatinine clearance > 30 mL/min

Cardiovascular

• No congestive heart failure
• No unstable angina pectoris
• No myocardial infarction within the past year
• No uncontrolled hypertension
• No high-risk uncontrolled arrhythmias

Other

• Geriatric Depression Score < 12
• No active uncontrolled infection
• No active peptic ulcer
• No uncontrolled diabetes mellitus
• No inflammatory bowel disease
• No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80
• No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent
• No familial, social, geographical, or psychological condition that would preclude study follow-up
• No definite contraindication to corticosteroids
• No other serious illness or medical condition
• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior or concurrent trastuzumab (Herceptin^®)

Chemotherapy

• Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed
• More than 2 years since prior docetaxel or paclitaxel
• No other concurrent chemotherapy

Endocrine therapy

• No more than 1 prior hormonal therapy regimen for metastatic disease
• At least 10 days since prior hormonal therapy
• No concurrent hormonal therapy

• No concurrent chronic corticosteroids

  • Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated > 6 months before study entry

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 30 days since prior active treatment on another clinical trial
• Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia
• No other concurrent anticancer therapy
• No other concurrent investigational drugs