Biomarker Change Linked to Breast CancerPhase 1/2NCT01769625
Changes in Biomarkers Using Prostaglandin Inhibitors
A Phase 1/2 study of Biomarker Change Linked to Breast Cancer, run by Hartford Hospital at 1 site in United States.
Trial summary
This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Biomarker Change Linked to Breast Cancer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2016
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Woman >18 years old
- Healthy women who are at normal risk for developing breast cancer
- ECOG Performance Status score 0-1
- Premenopausal women must not be pregnant
Who cannot join
- History of bilateral mastectomy, or bilateral breast irradiation
- Significant medical or psychiatric problems making the participant a poor candiate
- Evidence of excess use of narcotics or drug dependency
- Have been pregnant and lactating in the past 2 years
- Significant history of peptic ulcer disease or upper gastrointestinal bleeding
- History of severe congestive heart failure that requires hospitalization or intervention
Show all 12Show fewer
- History of asthma requiring medication for treatment
- Allergy to sulfonamides or NSAID medications
- History of myocardial infarction or stroke
- Currently on Coumadin
- Currently on Tamoxifen (nolvadex),Evista (raloxifene), Femara (letrozole), Arimidex (anastrozole), or Aromasin (exemestane)
- Undergone prior subaeolar breast surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Dakota
Grand Forks, North Dakota, 58202
About this study
Official title: Prostaglandin Inhibition to Prevent Breast Cancer
This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.
The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act together to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.
Read the detailed description
This is a biomarker study with the goal of measuring changes in protein and rna expression. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.
66 women at normal risk for developing breast cancer will be recruited and enrolled. 22 women will be randomized into each arm, with anticipation of 2 women in each group will not be evaluable, leaving 20 in each group for evaluation.
A combination of vitamin D and celecoxib act synergistically to decrease breast cancer risk by decreasing cell proliferation in the mammary epithelium through their action on prostaglandin synthesis and metabolism.
Specific Aims:
-Evaluate vitamin D metabolism, through the measurement of CYP24 in the breast.
2-Evaluate breast specific levels of vitamin D and celecoxib, and assess if the levels of these compounds correlate with response to markers which influence prostaglandin synthesis and metabolism. Additionally, in women without active breast cancer , we will determine the effect of vitamin D, with or without celecoxib, on 1) PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast, 2) proliferative activity in the breast,, and 3) circulating levels of vitamin D and celecoxib, to determine if levels of these compounds correlate with response to markers of PG production, metabolism, or cell proliferation.
- Conditions
- Biomarker Change Linked to Breast Cancer
- Being tested
- placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU
- Keywords
- breast, high risk women, biomarkers, vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IUDrug
Also called celecoxib (Celebrex), cholecalciferol (vitamin D), placebo (empty capule inside empty capsule
Take 1 capsule from each bottle (1 bottle containing either placebo/celecoxib and 1 bottle containing either cholecaliferol 400 IU/cholecaliferol 2,000 IU) for 30 days
| Study group | Role | What they receive |
|---|---|---|
| placebo & cholecalciferol 400 IU | Placebo comparator | In this arm, the placebo is in place of celecoxib and the current RDA for cholecalciferol is used the control of the cholecalciferol higher dose. Receives: Drug: placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU |
| placebo & cholecalciferol 2,000 IU | Active comparator | Placebo \& cholecalciferol 2,000 IU Receives: Drug: placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU |
| celecoxib 400mg & cholecalciferol 2,000 IU | Experimental | celecoxib 400 mg \& cholecalciferol2,000 IU Receives: Drug: placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast
This will be measured from both baseline and completion samples
- PG synthesis and metabolism, through the measurement of 15-PGDH, COX-2, and PGE2 in the breast
Rationale: 1,25(OH)2D, the active form of vitamin D, has been shown in vitro to decrease PGE2 both by interfering with its production and by increasing its breakdown, leading to lower cell proliferation. Celecoxib potentiated the antiproliferative effect, allowing a much lower dose of each agent when used in combination than in isolation.
Measured: approximately 30 days
Secondary outcomes (1)
proliferative activity in the breast and circulating levels of vitamin D and celecoxib, to determine if levels of these compounds correlate with response to markers of PG production, metabolism, or cell proliferation.
This will be measured from both baseline and completion samples.
- Proliferative activity in the breast, as measured by MD cell morphology
Rationale: Both MD and NAF contain ductal epithelial cells, but MD samples contain more cells for cytologic review than NAF. Findings on MD cytology correlate with likelihood of breast cancer, NAF cytology relates to breast cancer risk and improves risk stratification, and bioactive food components can alter NAF cytology
Measured: approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2009
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomarker Change Linked to Breast CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Principal investigator, Edward Sauter, The University of Texas Health Science Center at Tyler
- Investigators
- Edward R. Sauter, MD, PhD, M.H.A, Principal investigator, University of North Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769625
- Sponsor's protocol ID
- 200807-001
- Status last verified
- Aug 2017
- First submitted
- 14 Jan 2013
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostaglandin Inhibition to Prevent Breast Cancer
- ClinicalTrials.gov ID
- NCT01769625
- Acronym / sponsor ID
- 200807-001
- Conditions
- Biomarker Change Linked to Breast Cancer
- Keywords
- breast, high risk women, biomarkers, vitamin D
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Jan 2009
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Jan 2013 (estimated)
- 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.
This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.
The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act together to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.
Detailed description
This is a biomarker study with the goal of measuring changes in protein and rna expression. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.
66 women at normal risk for developing breast cancer will be recruited and enrolled. 22 women will be randomized into each arm, with anticipation of 2 women in each group will not be evaluable, leaving 20 in each group for evaluation.
A combination of vitamin D and celecoxib act synergistically to decrease breast cancer risk by decreasing cell proliferation in the mammary epithelium through their action on prostaglandin synthesis and metabolism.
Specific Aims:
-Evaluate vitamin D metabolism, through the measurement of CYP24 in the breast.
2-Evaluate breast specific levels of vitamin D and celecoxib, and assess if the levels of these compounds correlate with response to markers which influence prostaglandin synthesis and metabolism. Additionally, in women without active breast cancer , we will determine the effect of vitamin D, with or without celecoxib, on 1) PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast, 2) proliferative activity in the breast,, and 3) circulating levels of vitamin D and celecoxib, to determine if levels of these compounds correlate with response to markers of PG production, metabolism, or cell proliferation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo & cholecalciferol 400 IU | Placebo comparator | Drug: placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IUIn this arm, the placebo is in place of celecoxib and the current RDA for cholecalciferol is used the control of the cholecalciferol higher dose. |
| placebo & cholecalciferol 2,000 IU | Active comparator | Drug: placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IUPlacebo \& cholecalciferol 2,000 IU |
| celecoxib 400mg & cholecalciferol 2,000 IU | Experimental | Drug: placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IUcelecoxib 400 mg \& cholecalciferol2,000 IU |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Woman >18 years old
- Healthy women who are at normal risk for developing breast cancer
- ECOG Performance Status score 0-1
- Premenopausal women must not be pregnant
Key exclusion criteria (12 listed)
- History of bilateral mastectomy, or bilateral breast irradiation
- Significant medical or psychiatric problems making the participant a poor candiate
- Evidence of excess use of narcotics or drug dependency
- Have been pregnant and lactating in the past 2 years
- Significant history of peptic ulcer disease or upper gastrointestinal bleeding
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 |
|---|---|---|
| placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IUAlso: celecoxib (Celebrex), cholecalciferol (vitamin D), placebo (empty capule inside empty capsuleTake 1 capsule from each bottle (1 bottle containing either placebo/celecoxib and 1 bottle containing either cholecaliferol 400 IU/cholecaliferol 2,000 IU) for 30 days | Drug | celecoxib 400mg & cholecalciferol 2,000 IU, placebo & cholecalciferol 2,000 IU, placebo & cholecalciferol 400 IU |
Primary outcome
PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast
Time frame: approximately 30 days
This will be measured from both baseline and completion samples 1. PG synthesis and metabolism, through the measurement of 15-PGDH, COX-2, and PGE2 in the breast Rationale: 1,25(OH)2D, the active form of vitamin D, has been shown in vitro to decrease PGE2 both by interfering with its production and by increasing its breakdown, leading to lower cell proliferation. Celecoxib potentiated the antiproliferative effect, allowing a much lower dose of each agent when used in combination than in isolation.
1 secondary outcome
proliferative activity in the breast and circulating levels of vitamin D and celecoxib, to determine if levels of these compounds correlate with response to markers of PG production, metabolism, or cell proliferation.
Time frame: approximately 30 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 9 Aug 2017.
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.
Edward R. Sauter, MD, PhD, M.H.A principal investigator
University of North Dakota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Biomarker Change Linked to Breast Cancer, run by Hartford Hospital 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 4 inclusion and 12 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 9 Aug 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
PG synthesis and metabolism, through the measurement of PGE2, COX-2 and 15-PGDH in the breast (time frame: approximately 30 days). 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 9 Aug 2017; AzTrials last refreshed its copy on 31 Oct 2026.