RANKL Inhibition and Mammographic Breast Density

RECRUITING

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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.

Conditions:

🦠 Dense Breasts

🗓️ Study Start (Actual) 27 August 2019

🗓️ Primary Completion (Estimated) 31 August 2025

✅ Study Completion (Estimated) 31 August 2026

👥 Enrollment (Estimated) 210

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Saint Louis, Missouri, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 40 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 16 August 2019
First Submitted that Met QC Criteria 21 August 2019
First Posted 26 August 2019

Study Record Updates

Last Update Submitted that Met QC Criteria 23 April 2024
Last Update Posted 24 April 2024
Last Verified April 2024