At a glance
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Phase II Correlative Study of Denosumab Effects on Tissue and Imaging Breast Biomarkers
In Brief
A Phase 2 clinical trial evaluating Denosumab for Breast Cancer. Completed, enrolled 42 participants across 1 site.
Detailed Summary
This is a non-randomized phase II trial of denosumab at 120 mg subcutaneous injection monthly in pre- and post-menopausal women diagnosed with stage 0-III breast cancer who are currently not receiving anticancer treatment with hormonal therapies, chemotherapy, or radiation. All patients will undergo quantification of breast density by MRI at baseline and after 6 months on denosumab. Because the therapeutic agent is an injectable drug, the investigators will conduct a single arm study with both pre- and post-treatment measurements to determine the extent of variability in breast density over time and a placebo treatment period or group will not be utilized. This is an investigator initiated trial and Amgen (SPONSOR) will provide the trial drug denosumab.
Study Details
Timeline
Interventions
monthly subcutaneous injections