S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed stage IV breast cancer at primary diagnosis or at recurrence
• * Any T, any N, M1
• At least 1 dominant osteolytic or osteoblastic or mixed metastatic lesion outside any prior radiation field
• * Lesion measures ≥ 1.0 cm by x-ray, CT scan, and/or MRI
• Controlled asymptomatic brain metastases allowed
• Controlled bone pain, defined as a physician/health care provider rating of ≤ grade 2 pain-SELECT (Bone) on the NCI CTC for Adverse Events Version 3.0 rating scale, required
• Current evidence of vertebral or nonvertebral fractures or spinal compression due to cancer, as determined by the treating physician, allowed
• No Paget's disease of the bone
• Estrogen receptor (ER) or progesterone receptor (PR) status known
• PATIENT CHARACTERISTICS:
• Female patient
• Menopausal status not specified
• Zubrod performance status 0-2
• Creatinine normal
• Creatinine clearance ≥ 60 mL/min
• Serum calcium \< 12 mg/dL
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Must be able to receive IV medication and oral medication (i.e., must have physical integrity of the upper gastrointestinal tract)
• No malabsorption syndrome
• No primary hyperparathyroidism
• No known history of aspirin-sensitive asthma
• No other prior malignancy except for the following:
• * Adequately treated basal cell or squamous cell skin cancer
• * In situ cervical cancer
• * Adequately treated stage I or II cancer currently in complete remission
• * Any other cancer for which the patient has been disease-free for at least 5 years
• No uncontrolled medical illness or infection, including, but not limited to, the following:
• * Unstable angina
• * Recent myocardial infarction
• * Life-threatening cardiac arrhythmia
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior bisphosphonates for metastatic bone disease
• More than 28 days since prior aminoglycoside antibiotics
• At least 28 days since prior oral bisphosphonates for osteoporosis
• More than 6 months since prior bisphosphonates used for adjuvant therapy
• Concurrent treatment, including chemotherapy, hormonal therapy, and/or biologic therapy for metastatic breast cancer allowed
• No concurrent participation in another clinical treatment trial for this cancer unless the patient is no longer receiving the intervention and is in the follow-up phase of the other clinical trial