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

Inclusion Criteria

• •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