Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring hypercalcemia of malignancy, stage IV breast cancer, recurrent breast cancer, bone metastases, pain
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Radiographical evidence of at least 1 bone metastasis No prior radiotherapy or surgery to bone metastasis No radiotherapy or surgery anticipated for bone metastasis within the next 24 weeks Bone pain severity score of at least 1 on 5 of 7 days as determined by question 3 of the Brief Pain Inventory (BPI) No bone metastases to a weight-bearing bone at imminent risk for pathologic fracture or surgical intervention No vertebral metastases that place the patient at imminent risk of spinal cord compression Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Pre- or post-menopausal Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic WBC at least 2,000/mm^3 Lymphocyte count at least 500/mm^3 Granulocyte count at least 1,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic ALT or AST no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal Calcium no greater than 10.1 mg/dL No oliguria, defined as less than 30 mL urine per 2-hour collection No acute renal failure Creatinine no greater than 2.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No sepsis No known or anticipated contraindication to study drugs PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 3 weeks since initiation of a new chemotherapy regimen Endocrine therapy More than 3 weeks since initiation of a new hormonal therapy regimen Radiotherapy See Disease Characteristics More than 3 weeks since prior radiotherapy Surgery See Disease Characteristics Other More than 60 days since prior bisphosphonates More than 30 days since prior investigational drugs No change in analgesic drug regimen during the screening period
Sites / Locations
- Ireland Cancer Center