Clinical trial · Interventional
RANKL Inhibition and Breast Tissue Biomarkers
RANKL Inhibition and Breast Tissue Biomarkers in Premenopausal Women With Dense Breasts
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Prevention | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Mammographic Density | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Procedure | — | UNRESOLVED |
| Calcium | Drug | — | UNRESOLVED |
| Denosumab | Drug | Denosumab | ALIAS |
| Ultrasound-guided core needle biopsy | Procedure | — | UNRESOLVED |
| Vitamin D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Denosumab
- description
- 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.
- interventionNames
- Procedure: Ultrasound-guided core needle biopsy
- Drug: Denosumab
- Procedure: Blood draw
- Drug: Calcium
- Drug: Vitamin D
Primary outcomes (3)
- measure
- Effect of denosumab on breast tissue gene pathway gene expression
- timeFrame
- Between baseline and day 60
- description
- The investigators will evaluate changes in pathway gene expression between baseline and day 60 using NanoString NCounter platform
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available