RANKL Inhibition for Dense Breasts
(TRIDENT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 adoption of RANKL inhibition in primary breast cancer prevention are not yet available. The hypothesis is that RANKL inhibition with denosumab will decrease mammographic density in high-risk premenopausal women with dense breasts. To address this, the investigators have developed this clinical trial to quantify the impact of RANKL inhibition on mammographic density in high-risk premenopausal women with dense breasts and to determine the effect of RANKL inhibition on markers of proliferation and biomarkers of breast cancer risk. Successful demonstration that RANKL inhibition reduces mammographic density could open up additional approaches to primary breast cancer prevention in high-risk premenopausal women, who do not have dominant genetic predisposition.
Will I have to stop taking my current medications?
If you are currently using tamoxifen, aromatase inhibitors, bisphosphonates, or RANKL inhibitors, you will need to stop taking them to participate in this trial.
Is denosumab safe for humans?
How is the drug Denosumab unique for treating dense breasts?
What data supports the effectiveness of the drug Denosumab for dense breasts?
Research shows that Denosumab, which blocks a protein called RANKL, has been effective in reducing tumor growth and improving chemotherapy response in certain types of breast cancer. It is also used to prevent bone problems in cancer patients, suggesting it may help in conditions related to breast cancer.678910
Who Is on the Research Team?
Adetunji T Toriola, M.D., Ph.D., MPH
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for premenopausal women at least 40 years old with dense breasts, as shown on a mammogram. Participants must be able to consent and not have a history of certain breast conditions or cancer, known BRCA mutations, or be using related medications. They should not be pregnant or planning pregnancy during the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous injections of denosumab or placebo at baseline and 6 months, with daily calcium and vitamin D supplements for 12 months
Follow-up
Participants are monitored for changes in mammographic breast density and biomarkers at 24 months, with an optional assessment at 36 months
What Are the Treatments Tested in This Trial?
Interventions
- Denosumab
Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
National Institutes of Health (NIH)
Collaborator