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

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