Breast Cancer PreventionEarly Phase 1NCT03629717
RANKL Inhibition and Breast Tissue Biomarkers
A Early Phase 1 study testing Ultrasound-guided core needle biopsy, Denosumab and Blood draw in people with Breast Cancer Prevention and Mammographic Density, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Cancer Prevention, Mammographic Density
- What is being tested?
- Ultrasound-guided core needle biopsy, Denosumab and Blood draw
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 3 Dec 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: RANKL Inhibition and Breast Tissue Biomarkers in Premenopausal Women With Dense Breasts
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
- Breast Cancer Prevention, Mammographic Density
- Being tested
- Ultrasound-guided core needle biopsy, Denosumab, Blood draw, Calcium, Vitamin D
- Keywords
- Mammographic density, Premenopausal, Breast cancer, Chemoprevention, Denosumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided core needle biopsyProcedure or surgery
Tissue collection for this research proposal will be used for research purposes only and will not inform participant care
DenosumabDrug
Also called Xgeva, Prolia
Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL
Blood drawProcedure or surgery
20 mL of fasting whole blood will be collected before denosumab (Day 1) and one month after denosumab administration (day 60 +/- 10 days)
CalciumDrug
1200mg daily
Vitamin DDrug
800 IU daily
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | 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. Receives: Procedure: Ultrasound-guided core needle biopsy; Drug: Denosumab; Procedure: Blood draw; Drug: Calcium; Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of denosumab on breast tissue gene pathway gene expression
The investigators will evaluate changes in pathway gene expression between baseline and day 60 using NanoString NCounter platform
Measured: Between baseline and day 60
Effect of denosumab on pathways that may influence breast cancer development as measured by spatial transcriptomic analysis
The investigators will evaluate changes in breast tissue spatial transcriptomics.
Measured: Between baseline and day 60
Effect of denosumab on pathways that may influence breast cancer development as measured by metabolomic analysis
The investigators will evaluate changes in metabolomics.
Measured: Between baseline and day 60
Secondary outcomes (1)
Correlation of breast tissue gene expression with circulating biomarker levels
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Jun 2018
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PreventionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adetunji T Toriola, M.D., Ph.D., MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629717
- Sponsor's protocol ID
- 201801105
- Status last verified
- Oct 2024
- First submitted
- 1 Aug 2018
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANKL Inhibition and Breast Tissue Biomarkers in Premenopausal Women With Dense Breasts
- ClinicalTrials.gov ID
- NCT03629717
- Acronym / sponsor ID
- 201801105
- Conditions
- Breast Cancer Prevention, Mammographic Density
- Keywords
- Mammographic density, Premenopausal, Breast cancer, Chemoprevention, Denosumab
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Procedure: Ultrasound-guided core needle biopsy, Drug: Denosumab, Procedure: Blood draw, Drug: Calcium, Drug: Vitamin DAn 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided core needle biopsyTissue collection for this research proposal will be used for research purposes only and will not inform participant care | Procedure or surgery | Denosumab |
| DenosumabAlso: Xgeva, ProliaDenosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL | Drug | Denosumab |
| Blood draw20 mL of fasting whole blood will be collected before denosumab (Day 1) and one month after denosumab administration (day 60 +/- 10 days) | Procedure or surgery | Denosumab |
| Calcium1200mg daily | Drug | Denosumab |
| Vitamin D800 IU daily | Drug | Denosumab |
Primary outcome
Effect of denosumab on breast tissue gene pathway gene expression
Time frame: Between baseline and day 60
The investigators will evaluate changes in pathway gene expression between baseline and day 60 using NanoString NCounter platform
Effect of denosumab on pathways that may influence breast cancer development as measured by spatial transcriptomic analysis
Time frame: Between baseline and day 60
The investigators will evaluate changes in breast tissue spatial transcriptomics.
Effect of denosumab on pathways that may influence breast cancer development as measured by metabolomic analysis
Time frame: Between baseline and day 60
The investigators will evaluate changes in metabolomics.
1 secondary outcome
Correlation of breast tissue gene expression with circulating biomarker levels
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adetunji T Toriola, M.D., Ph.D., MPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ultrasound-guided core needle biopsy, Denosumab and Blood draw in people with Breast Cancer Prevention and Mammographic Density, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of denosumab on breast tissue gene pathway gene expression (time frame: Between baseline and day 60). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.