RANKL Inhibition and Breast Tissue Biomarkers
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 3/6/2019 |
| Start Date: | June 1, 2018 |
| End Date: | May 31, 2019 |
| Contact: | Adetunji T Toriola, M.D., Ph.D., MPH |
| Email: | a.toriola@wustl.edu |
| Phone: | 314-286-2668 |
RANKL Inhibition and Breast Tissue Biomarkers in Premenopausal Women With Dense Breasts
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.
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.
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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Adetunji T Toriola, M.D., Ph.D., MPH
Phone: 314-286-2668
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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