drugset / Trial / NCT02613416

Denosumab and MRI Breast Imaging

NCT02613416

Phase 2 Completed 42 enrolled Alison Stopeck Amgen · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-11
Primary completion
2021-08-20
Completion
2021-08-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 120 mg Subcutaneous

Indications