At a glance
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Phase II Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Ra-223 dichloride, Denosumab, and 1 other intervention for Breast Cancer. Completed, enrolled 45 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if Xofigo® (also called Ra-223 dichloride) combined with hormone therapy and denosumab can help to control breast cancer that has spread to the bones and/or bone marrow. The safety of this study drug combination will also be studied. This is an investigational study. Denosumab and the hormone therapies used in this study are FDA-approved and commercially available for the treatment of metastatic breast cancer. Ra-223 dichloride is FDA-approved and commercially available for the treatment of bone metastases. It is considered investigational to use the combination of Ra-223 dichloride, hormone therapy and denosumab to treat patients with bone cancer that has spread to the bones. The study doctor can explain how the study drugs are designed to work. Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.
Study Details
Timeline
Interventions
55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.
120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.