S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone
Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring pain, hypercalcemia of malignancy, stage IV breast cancer, bone metastases, recurrent breast cancer
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
zoledronate
ibandronate
zoledronate
ibandronate