Saint Louis, Missouri 63110


Purpose:

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.


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.


NCT ID:

NCT03629717


Primary Contact:

Principal Investigator
Adetunji T Toriola, M.D., Ph.D., MPH
Washington University School of Medicine

Adetunji T Toriola, M.D., Ph.D., MPH
Phone: 314-286-2668
Email: a.toriola@wustl.edu


Backup Contact:

Email: edavies@wustl.edu
Esinam Wash, MPH
Phone: 314-286-2779


Location Contact:

Saint Louis, Missouri 63110
United States

Adetunji T Toriola, M.D., Ph.D., MPH
Phone: 314-286-2668
Email: a.toriola@wustl.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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