Status:
ACTIVE_NOT_RECRUITING
RANKL Inhibition and Mammographic Breast Density
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Dense Breasts
Eligibility:
FEMALE
40+ years
Phase:
PHASE2
Brief Summary
Data supporting a role for RANKL signaling in mammographic density and breast cancer development has begun to emerge, but clinical trial data providing definitive evidence that would allow the adoptio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04067726
Start Date
August 27 2019
End Date
August 31 2026
Last Update
October 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110