Breast CancerPhase 1/2NCT01425476
Changes in Breast Cancer Biomarkers Using Synergistic Prostaglandin Inhibitors
A Phase 1/2 study testing Celecoxib and Cholecalciferol in people with 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
- Breast Cancer
- What is being tested?
- Celecoxib and Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to 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
- Women 18 years of age or older
- Increased risk for breast cancer (demonstrated by strong family history [one 1st degree or two 2nd degree relatives], history of DCIS, IBC, or precancerous changes in breasts). OR Gail Model risk of developing IBC in a 5-year period of >1.66%
- Women with a history of breast cancer, must be free of disease and finished with treatment
- 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 candidate
- 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, 58203
About this study
Official title: Breast Cancer Prevention Using Synergistic Prostaglandin Inhibitors (The Vitamin D/Celecoxib Study)
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), 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 high risk for breast cancer (gail risk >/= 1.66% for 5 year risk, or personal or family history)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:
In women at increased breast cancer risk, determine the effect of vitamin D, with or without celecoxib, on
- 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.
- Proliferative activity in the breast, as measured by Mammary Ductoscopy (MD) cell morphology Rationale: Both MD and Nipple Aspirate Fluid (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 (2), NAF cytology relates to breast cancer risk and improves risk stratification (3), and bioactive food components can alter NAF cytology (4).
- Circulating levels of 25(OH)D, 1,25(OH)2D, and celecoxib, and determine if the levels of these compounds correlate with response to markers of PG synthesis and metabolism or cell proliferation.
- Conditions
- Breast Cancer
- Being tested
- Celecoxib, Placebo, Cholecalciferol
- Keywords
- breast, high risk women, biomarkers, vitamin D
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called celecoxib (Celebrex)
Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.
PlaceboDrug
Also called placebo (empty capsule inside an empty capsule)
Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.
CholecalciferolDrug
Also called cholecalciferol (Vitamin D)
Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily 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; Drug: Cholecalciferol |
| Placebo & cholecalciferol 2,000 IU | Active comparator | Not described Receives: Drug: Placebo; Drug: Cholecalciferol |
| celecoxib 400 mg & cholecalciferol 2,000 IU | Experimental | Not described Receives: Drug: Celecoxib; Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
PG synthesis and metabolism
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 (2)
Proliferative activity in the breast, as measured by MD cell morphology
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
Circulating levels of 25(OH)D, 1,25(OH)2D, and celecoxib
This will be measured from both baseline and completion samples.
- Circulating levels of 25(OH)D, 1,25(OH)2D, and celecoxib, and determine if the levels of these compounds correlate with response to markers of PG synthesis and metabolism or cell proliferation.
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 posted30 Aug 2011 (estimated)
- Study startJul 2008
- 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 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of North Dakota
- Responsible party
- Principal investigator, Edward Sauter, The University of Texas Health Science Center at Tyler
- Investigators
- Edward Sauter, MD, PhD, Principal investigator, University of North Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425476
- Sponsor's protocol ID
- 200806
- Status last verified
- Aug 2017
- First submitted
- 26 Apr 2011
- 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
- Breast Cancer Prevention Using Synergistic Prostaglandin Inhibitors (The Vitamin D/Celecoxib Study)
- ClinicalTrials.gov ID
- NCT01425476
- Acronym / sponsor ID
- 200806
- Conditions
- Breast Cancer
- Keywords
- breast, high risk women, biomarkers, vitamin D
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense, University of North Dakota
- Study start
- Jul 2008
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Aug 2011 (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), 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 high risk for breast cancer (gail risk >/= 1.66% for 5 year risk, or personal or family history)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:
In women at increased breast cancer risk, determine the effect of vitamin D, with or without celecoxib, on
- 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.
- Proliferative activity in the breast, as measured by Mammary Ductoscopy (MD) cell morphology Rationale: Both MD and Nipple Aspirate Fluid (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 (2), NAF cytology relates to breast cancer risk and improves risk stratification (3), and bioactive food components can alter NAF cytology (4).
- Circulating levels of 25(OH)D, 1,25(OH)2D, and celecoxib, and determine if the levels of these compounds correlate with response to markers of PG synthesis and 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, Drug: CholecalciferolIn 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, Drug: Cholecalciferol |
| celecoxib 400 mg & cholecalciferol 2,000 IU | Experimental | Drug: Celecoxib, Drug: Cholecalciferol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women 18 years of age or older
- Increased risk for breast cancer (demonstrated by strong family history [one 1st degree or two 2nd degree relatives], history of DCIS, IBC, or precancerous changes in breasts). OR Gail Model risk of developing IBC in a 5-year period of >1.66%
- Women with a history of breast cancer, must be free of disease and finished with treatment
- 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 candidate
- 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 |
|---|---|---|
| CelecoxibAlso: celecoxib (Celebrex)Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days. | Drug | celecoxib 400 mg & cholecalciferol 2,000 IU |
| PlaceboAlso: placebo (empty capsule inside an empty capsule)Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days. | Drug | Placebo & cholecalciferol 2,000 IU, Placebo & cholecalciferol 400 IU |
| CholecalciferolAlso: cholecalciferol (Vitamin D)Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days. | Drug | Placebo & cholecalciferol 2,000 IU, Placebo & cholecalciferol 400 IU, celecoxib 400 mg & cholecalciferol 2,000 IU |
Primary outcome
PG synthesis and metabolism
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.
2 secondary outcomes
Proliferative activity in the breast, as measured by MD cell morphology
Time frame: approximately 30 days
Circulating levels of 25(OH)D, 1,25(OH)2D, and celecoxib
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.
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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.
Edward Sauter, MD, PhD 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 testing Celecoxib and Cholecalciferol in people with 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 5 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 (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.