RANKL Inhibition and Mammographic Breast Density

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Aug 21, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called denosumab, which blocks a protein involved in bone and breast health, can reduce mammographic breast density in women at high risk for breast cancer. Dense breast tissue can make it harder to spot cancer on mammograms, and women with dense breasts may have a higher risk of developing breast cancer. The trial aims to determine if reducing breast density through RANKL inhibition might offer a new way to help prevent breast cancer in premenopausal women who do not have a strong family history of the disease.

To be eligible for the trial, participants must be female, at least 40 years old, and premenopausal, with dense breasts as shown on a mammogram. Women who have had certain types of breast cancer or are currently using specific breast cancer medications cannot participate. Those who join the trial will receive denosumab and undergo regular monitoring to see how it affects their breast density and other factors related to breast cancer risk. It’s important for potential participants to understand that this trial is currently active but not recruiting new participants at this time.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female.
• • Premenopausal (when menopausal status is uncertain, the investigators will measure follicle-stimulating hormone and estradiol to ascertain that a partcipant is premenopausal)
• • At least 40 years of age.
• • Dense breasts on routine mammogram (BI-RADS Category C and D)
• • Able to understand and willing to sign an IRB-approved written informed consent document.
• Exclusion Criteria:
• • History of breast or any other invasive cancer except for DCIS (ductal carcinoma in situ) who received only lumpectomy, LCIS (lobular carcinoma in situ), atypical hyperplasia, non-melanoma skin cancer, carcinoma in situ of the cervix.
• • Current use of tamoxifen, aromatase inhibitors, or bisphosphonates, or RANKL inhibitors
• • Concurrent participation in another cancer chemoprevention trial (unless no longer receiving the intervention).
• • Pregnant, lactating, or planning to get pregnant while the trial is ongoing.
• • Recent history of invasive dental procedure (e.g. tooth extraction, dental implant, oral surgery).
• • Unhealed and/or planned dental/oral surgery.
• • History of osteonecrosis/osteomyelitis of the jaw.
• • History of osteoporosis or severe osteopenia.