drugset / Trial / NCT03629717
RANKL Inhibition and Breast Tissue Biomarkers
NaSingle-groupOpen-labelPrevention
Summary
A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. The investigators propose to investigate the effect of RANKL inhibition with denosumab on breast tissue markers in high-risk premenopausal women with dense breasts. Study findings could provide robust evidence to move forward with a clinical trial targeting RANKL inhibition in premenopausal breast cancer prevention.
Timeline
- Start
- 2018-06-01
- Primary completion
- 2018-12-03
- Completion
- 2018-12-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Background | Calcium carbonate | Other / unclassified | 1200 mg | — |
| Background | Vitamin D | Other / unclassified | 800 iu | — |