Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
10 participants
INTERVENTIONAL
2018-06-01
2018-12-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Histology of Functional Density in Premenopausal Breast
NCT01588834
Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32
NCT01286233
Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
NCT05926024
A Multicenter Breast Cancer Biospecimen Registry
NCT02712645
Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
NCT00620373
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Denosumab
An ultrasound-guided core needle breast biopsy will be performed on day 1 prior to the intervention. A single dose of subcutaneous denosumab 60mg will be administered immediately after the core biopsy on day 1. This will take place on an outpatient basis. Repeat core-needle biopsy will take place on Day 60 (+/-10 days). Blood samples will also be collected at the time of core-needle biopsy to allow for biomarker assay. Gene expression analyses will be done using NanoString nCounter gene expression system.
Ultrasound-guided core needle biopsy
Tissue collection for this research proposal will be used for research purposes only and will not inform participant care
Denosumab
Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL
Blood draw
20 mL of fasting whole blood will be collected before denosumab (Day 1) and one month after denosumab administration (day 60 +/- 10 days)
Calcium
1200mg daily
Vitamin D
800 IU daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ultrasound-guided core needle biopsy
Tissue collection for this research proposal will be used for research purposes only and will not inform participant care
Denosumab
Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL
Blood draw
20 mL of fasting whole blood will be collected before denosumab (Day 1) and one month after denosumab administration (day 60 +/- 10 days)
Calcium
1200mg daily
Vitamin D
800 IU daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
35 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adetunji T Toriola, M.D., Ph.D., MPH
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201801105
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.