Healthy Volunteer, Female, BreastPhase 1NCT02099461
Effect of Denosumab on Cellular Biomarkers in the Human Breast
A Phase 1 study testing Denosumab and Percutaneous core needle breast biopsy in people with Healthy Volunteer, Female, Breast, run by Amgen at 3 sites in United States.
Trial summary
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Female, Breast
- What is being tested?
- Denosumab and Percutaneous core needle breast biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to Jul 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to use, in combination with her partner, 2 non-hormonal methods of effective contraception or practice sexual abstinence. Subjects who are surgically sterile (eg, history of hysterectomy) or whose sexual partner is sterile (eg, history of vasectomy) are not required to use contraceptive measures
- Laboratory tests are within clinically acceptable range
- Clinically acceptable physical exam and no history or evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures.
Who cannot join
- Female subject with a prior history of breast cancer; breast implant in the breast to be biopsied; Known history of fibrocystic breast disease
- Subject is unable or unwilling to provide breast biopsy tissue from the upper outer quadrant of her breast
- Pregnant or plans to become pregnant while exposed to investigational product
- Lactating/breastfeeding or plans to breastfeed while exposed to investigational product
- Recent use of any non-approved medications or devices
- Uncontrolled thyroid disorder
Show all 9Show fewer
- Significant dental/oral disease
- Planned invasive dental procedures
- Positive urine screen for alcohol and/or drugs
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Cypress, California, 90630
Research Site
Hollywood, Florida, 33024
Research Site
Miami, Florida, 33143
About this study
Official title: A Randomized, Stratified, Open-label, No-treatment-controlled, Parallel Group, Multicenter Phase 1 Trial to Evaluate the Effect of Denosumab on Cellular Proliferation in the Human Breast
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
- Conditions
- Healthy Volunteer, Female, Breast
- Being tested
- Denosumab, Percutaneous core needle breast biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Single sucutaneous dose
Percutaneous core needle breast biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Other | Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28. Receives: Procedure: Percutaneous core needle breast biopsy |
| Denosumab 60 mg | Experimental | Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28. Receives: Drug: Denosumab; Procedure: Percutaneous core needle breast biopsy |
| Denosumab 120 mg | Experimental | Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28. Receives: Drug: Denosumab; Procedure: Percutaneous core needle breast biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells
Ki-67 is a marker for cell proliferation. Participants underwent percutaneous core needle breast biopsies on Day 1 (Baseline, prior to treatment) and Day 28. Levels of Ki67 were measured using immunohistochemical staining and digital imaging. The proliferation index was calculated as the percentage of Ki-67 positive terminal ductal lobular unit (TDLU) and duct epithelial cells. The higher the percentage, the higher the rate of epithelial cell proliferation.
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Volunteer, Female, BreastStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099461
- Sponsor's protocol ID
- 20130349
- Status last verified
- Aug 2015
- First submitted
- 25 Feb 2014
- Last updated
- 24 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Stratified, Open-label, No-treatment-controlled, Parallel Group, Multicenter Phase 1 Trial to Evaluate the Effect of Denosumab on Cellular Proliferation in the Human Breast
- ClinicalTrials.gov ID
- NCT02099461
- Acronym / sponsor ID
- 20130349
- Conditions
- Healthy Volunteer, Female, Breast
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Posted 24 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No treatment | Other | Procedure: Percutaneous core needle breast biopsyParticipants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28. |
| Denosumab 60 mg | Experimental | Drug: Denosumab, Procedure: Percutaneous core needle breast biopsyParticipants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28. |
| Denosumab 120 mg | Experimental | Drug: Denosumab, Procedure: Percutaneous core needle breast biopsyParticipants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willing to use, in combination with her partner, 2 non-hormonal methods of effective contraception or practice sexual abstinence. Subjects who are surgically sterile (eg, history of hysterectomy) or whose sexual partner is sterile (eg, history of vasectomy) are not required to use contraceptive measures
- Laboratory tests are within clinically acceptable range
- Clinically acceptable physical exam and no history or evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures.
Key exclusion criteria (9 listed)
- Female subject with a prior history of breast cancer; breast implant in the breast to be biopsied; Known history of fibrocystic breast disease
- Subject is unable or unwilling to provide breast biopsy tissue from the upper outer quadrant of her breast
- Pregnant or plans to become pregnant while exposed to investigational product
- Lactating/breastfeeding or plans to breastfeed while exposed to investigational product
- Recent use of any non-approved medications or devices
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 |
|---|---|---|
| DenosumabSingle sucutaneous dose | Drug | Denosumab 120 mg, Denosumab 60 mg |
| Percutaneous core needle breast biopsy | Procedure or surgery | Denosumab 120 mg, Denosumab 60 mg, No treatment |
Primary outcome
Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells
Time frame: Baseline and Day 28
Ki-67 is a marker for cell proliferation. Participants underwent percutaneous core needle breast biopsies on Day 1 (Baseline, prior to treatment) and Day 28. Levels of Ki67 were measured using immunohistochemical staining and digital imaging. The proliferation index was calculated as the percentage of Ki-67 positive terminal ductal lobular unit (TDLU) and duct epithelial cells. The higher the percentage, the higher the rate of epithelial cell proliferation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Healthy Volunteer, Female, Breast
Not yet recruitingEarly Phase 1
Evaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers and Patients With Cancer
Bladder Cancer, Glioma
RecruitingPhase 1
A Study to Assess Zilucoplan Concentration in Breast Milk of Healthy Lactating Women
Healthy Participants
RecruitingPhase 2
Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
Breast Cancer, Kidney Neoplasms
Not yet recruitingPhase 2/3
Postpartum 8-aminoquinoline Breast Milk Study
Drug Pharmacokinetics in Healthy Volunteers
RecruitingObservational study
Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
Healthy Volunteer, Prostate Cancer
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.
MD study director
Amgen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Denosumab and Percutaneous core needle breast biopsy in people with Healthy Volunteer, Female, Breast, run by Amgen at 3 sites 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 3 inclusion and 9 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 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells (time frame: Baseline and Day 28). 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 24 Sep 2015.