Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
NCT00060138 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2013-05-15
Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. It is not yet known whether monoclonal antibody is more effective than zoledronate in treating women who have breast cancer and bone metastases.
PURPOSE: Randomized phase I/II trial to compare the effectiveness of monoclonal antibody with that of zoledronate in treating women who have breast cancer and bone metastases.
Conditions
- Breast Cancer
- Hypercalcemia of Malignancy
- Metastatic Cancer
- Pain
Interventions
- BIOLOGICAL
-
monoclonal antibody CAL
- DRUG
-
zoledronic acid
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Chugai Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Paula Silverman, MD · Case Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-11-30
- Primary Completion
- 2004-09-30
Countries
- United States
Study Locations
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