A Phase III Randomized, Multicentered Non-Inferiority Trial Evaluating the Efficacy of Oral Ibandronate versus Intravenous Zoledronate in the Reduction of Skeletal-Related Events in Patients with Metastatic Breast Cancer

Pts must be female and must have Stage IV breast Ca, histologically confirmed. Pts must also have known estrogen or progestrone receptor status. Must have at least one dominant ostelytic or osteoblastic or mixed metastatic lesion that is outside any prior RT field and measures at least 1.0 cm by x-ray, CT and/or MRI w/i 42 days prior to reg. Concurrent tx, including chemo, hormonal tx, and/or biologic tx for metastatic breast Ca is allowed. Pts must have adequate renal function and must have serum Ca < 12 mg/dL measured w/i 28 days prior to reg. Pts w/ current evidence of vertebral or non-verterbal fractures due to Ca, or pts w/ current evidence of spinal compression due to Ca are eligible. Pts must have controlled bone pain as determined by the NCI-CTCAE v3.0. Oral bisphosphonates for osteoporis must be d/c at least 28 days prior to reg. Bisphosphonates used for adjuvant tx are not allowed w/i six mo prior to reg. Pts must not have had prior tx w/ bisphosphonates for met bone dz. Pts who can complete forms in English must have completed QOL forms w/i 14 days prior to reg. The nurse or CRA must complete study specific questionnaires w/i 14 days prior to reg. Pts unable to complete forms in English can register w/o contributing to the QOL component of this study. Pts must have baseline bone scan and either CT or MRI which includes the dominant lesion all w/i 42 days prior to reg. Pts must be able to receive meds IV and must be able to take meds PO. Pts must not have malabsorption syndrome. Pts must not have been tx with aminoglycoside antibiotics w/i 28 days prior to reg. Must not have uncontrolled med illness or infection including angina, recent MI, or life-threating arrhythmias. Pts with Paget's dz of the bone or primary hyperparathyroidism are not eligible. Must not have known history of aspirin-sensitive asthma. Pts must not participate in any other concurrent clinicl tx trial for their Ca unless they are no longer receiving the intervention and are in f/u phase only. Pts must have PS 0 -2.

CANCER CONTROL CREDIT: 1.0