Breast Cancer Clinical Trial
RANKL Inhibition and Breast Tissue Biomarkers
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.
Eligibility Criteria
Inclusion Criteria:
Female.
Premenopausal.
At least 35 years of age.
Dense breasts on routine mammogram.
Willing to take calcium (1,200mg) and vitamin D (800 IU) daily.
At increased risk for breast cancer using any of the following:
Positive family history of breast cancer
Breast cancer risk prediction models
Able and willing to return for repeat biopsy.
Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria:
Current use of tamoxifen, aromatase inhibitors, or bisphosphonates.
Concurrently participating in another cancer chemoprevention trial (unless no longer receiving the intervention).
Pregnant or lactating.
Recent tooth extraction or dental procedure.
Unhealed and/or planned dental/oral surgery.
History of osteonecrosis/osteomyelitis of the jaw.
History of osteoporosis or severe osteopenia.
Unable/unwilling to return for repeat biopsy.
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There is 1 Location for this study
Saint Louis Missouri, 63110, United States
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