Breast CancerNCT01166763
Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D
A study testing vitamin D3 in people with Breast Cancer, run by Carol Fabian, MD at 1 site in United States.
Trial summary
The overall goal of this project is to determine if high dose vitamin D3 given to premenopausal women at high risk for development of breast cancer, who initially have insufficient levels of 25-hydroxy vitamin D (<30 ng/ml), will raise 25(OH)D levels above 50 ng/ml. Read more about this study
- Who is it for?
- Ages Up to 55 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jun 2011
- Phase
- Interventional
- 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 Up to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects must be premenopausal women age 55 or younger, and actively menstruating with 4 or more periods per year.
- Subjects may be using barrier contraceptive, an intrauterine device, a Nuvaring, or similar non-oral contraceptive; or oral contraceptives.
- Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria:
- five-year Gail risk of 3X the average risk of the age group;
- a first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer;
- prior biopsy exhibiting atypical hyperplasia (AH), LCIS, DCIS, RPFNA evidence of hyperplasia with atypia within the last three years;
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- Chest or neck radiation before age 30;
- Breast density equals or exceeds 50 percent.
- If previously on a chemoprevention agent or prevention trial, subjects must have completed study participation at least 6 months prior to baseline biomarker assessment.
- If subject has a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen and is either not eligible or is not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy).
- Subject must have had a mammogram performed at the University of Kansas Breast Imaging Center with estimated visual breast density of greater than 10 percent.
- Subject must have had within six months prior to entering the study, an RPFNA during the follicular portion (day 1-10) of the menstrual cycle with material for cytomorphology, Ki-67 and qRT-PCR; in addition to serum obtained and banked.
- Subjects must have 25(OH)D level < 30 ng/ml as measured within 8 weeks of starting intervention. Subjects may have been identified as having low vitamin D levels through participation in HSC 11313, Osteopenia/Osteoporosis in Pre-menopausal Women at High Risk for Development of Breast Cancer, but low level must be confirmed within 8 weeks prior to starting study agent Subject must be willing to continue the same hormonal milieu present at baseline throughout trial.
- Subjects must be willing to undergo measurement of height, weight, and BMI at initiation of intervention.
- Subjects must have participated in HSC 11313, and have had a DEXA scan for bone density and body fat analysis on the GE Lunar Prodigy Advance research unit in the Breast Cancer Survivorship Center.
- Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA.
Who cannot join
- Women that have had a metastatic malignancy of any kind.
- Women that have had prior invasive breast cancer If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contra-lateral (uninvolved breast) will be studied by FNA. The subject may not have had any radiation therapy to the contra-lateral breast to be studied.
- Women who are pregnant or nursing.
- Women who have taken a SERM, aromatase inhibitor or participated in a chemoprevention or other investigational drug study within six months prior to baseline FNA.
- Women who have used fertility drugs within six months prior to baseline aspiration.
- Women with a history of sarcoidosis, hypercalcemia, hyperparathyroidism, or renal stones.
- Women who are receiving treatment for rheumatoid arthritis or other connective tissue diseases.
- Women who have an elevated blood calcium level at baseline; defined as any elevation above the institutional normal range.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The overall goal of this project is to determine if high dose vitamin D3 given to premenopausal women at high risk for development of breast cancer, who initially have insufficient levels of 25-hydroxy vitamin D (<30 ng/ml), will raise 25(OH)D levels above 50 ng/ml. If so, will certain risk biomarkers for development of breast cancer be reliably and favorably modulated?
Read the detailed description
Protocol Objectives:
To determine if high dose vitamin D3 given to premenopausal women who initially have insufficient levels of 25-hydroxy vitamin D (<30 ng/ml) will raise 25(OH)D levels above the 50 ng/ml level considered to be required for breast health. If so, will certain risk biomarkers for development of breast cancer be reliably and favorably modulated? The primary endpoint will be a decrease in mammographic breast density (percent area considered at increased density). Change in proliferation (a decrease as assessed by Ki-67) will also be examined. Modulate of expression of genes important in breast cancer risk or reflective of vitamin D's mechanism of action will be studied using quantitative real time polymerase chain reaction (qRT-PCR).
Study Design:
The study is a single-arm open label clinical trial. Women who are high risk for development of breast cancer on the basis of family or personal history will undergo random periareolar fine needle aspiration (RPFNA) to acquire breast cells for assessment of gene expression by qRT-PCR. Women with mammographic density >10% will be eligible for enrollment. All subjects will receive high dose vitamin D3 (3 capsules of 10,000 IU of vitamin D3 every week for 6-8 months). At that time, a repeat RPFNA and mammogram will be performed. Measurement of serum levels of 25(OH)D will be performed at baseline, 3 months, and 6 months.
- Conditions
- Breast Cancer
- Being tested
- vitamin D3
- Keywords
- breast atypia, high risk for breast cancer, random periareolar fine needle aspiration, RPFNA, breast epithelial hyperplasia, ki-67, chemoprevention, vitamin D3, Additional relevant MeSH terms:, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Breast Neoplasms, Pharmacologic Actions, Hyperplasia, high risk for development of breast cancer, Neoplasms, Neoplasms by Site, Pathologic Processes, Antirheumatic Agents, Breast Diseases
- Medical subject headings
- Breast Neoplasms, Hyperplasia, Neoplasms, Neoplasms by Site, Pathologic Processes, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Drug
Also called Maximum D3
oral capsules, 10,000 IU per week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| high dose vitamin D3 (10,000 IU weekly) | Experimental | Group/Cohort Label vitamin D3 Receives: Drug: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mammographic Breast Density Over Course of Study
Change in the percent of the breast area that is considered to be at higher density on mammogram.
Measured: baseline and 6 months
Secondary outcomes (2)
Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.
Change in percent of cells expressing staining for Ki-67 antibody in breast epithelial cell specimens acquird by Random Periareolar Fine Needle Aspiration.
Measured: baseline and 6 months
OH Vitamin D Levels in Serum
Assessment of 25(OH)D levels as a measure of circulating vitamin D.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionJun 2011
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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Fabian, MD
- Sponsor type
- University, hospital or other
- Collaborators
- BTR Group
- Responsible party
- Sponsor-investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol Fabian, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166763
- Sponsor's protocol ID
- 11657
- Status last verified
- Jun 2016
- First submitted
- 16 Jul 2010
- Last updated
- 18 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Global results only will be published.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D
- ClinicalTrials.gov ID
- NCT01166763
- Acronym / sponsor ID
- 11657
- Conditions
- Breast Cancer
- Keywords
- breast atypia, high risk for breast cancer, random periareolar fine needle aspiration, RPFNA, breast epithelial hyperplasia, ki-67, chemoprevention, vitamin D3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Carol Fabian, MDUniversity, hospital or other
- Collaborators
- BTR Group
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Posted 10 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this project is to determine if high dose vitamin D3 given to premenopausal women at high risk for development of breast cancer, who initially have insufficient levels of 25-hydroxy vitamin D (<30 ng/ml), will raise 25(OH)D levels above 50 ng/ml. If so, will certain risk biomarkers for development of breast cancer be reliably and favorably modulated?
Detailed description
Protocol Objectives:
To determine if high dose vitamin D3 given to premenopausal women who initially have insufficient levels of 25-hydroxy vitamin D (<30 ng/ml) will raise 25(OH)D levels above the 50 ng/ml level considered to be required for breast health. If so, will certain risk biomarkers for development of breast cancer be reliably and favorably modulated? The primary endpoint will be a decrease in mammographic breast density (percent area considered at increased density). Change in proliferation (a decrease as assessed by Ki-67) will also be examined. Modulate of expression of genes important in breast cancer risk or reflective of vitamin D's mechanism of action will be studied using quantitative real time polymerase chain reaction (qRT-PCR).
Study Design:
The study is a single-arm open label clinical trial. Women who are high risk for development of breast cancer on the basis of family or personal history will undergo random periareolar fine needle aspiration (RPFNA) to acquire breast cells for assessment of gene expression by qRT-PCR. Women with mammographic density >10% will be eligible for enrollment. All subjects will receive high dose vitamin D3 (3 capsules of 10,000 IU of vitamin D3 every week for 6-8 months). At that time, a repeat RPFNA and mammogram will be performed. Measurement of serum levels of 25(OH)D will be performed at baseline, 3 months, and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high dose vitamin D3 (10,000 IU weekly) | Experimental | Drug: vitamin D3Group/Cohort Label vitamin D3 |
Who may qualify
- Ages
- Up to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Subjects must be premenopausal women age 55 or younger, and actively menstruating with 4 or more periods per year.
- Subjects may be using barrier contraceptive, an intrauterine device, a Nuvaring, or similar non-oral contraceptive; or oral contraceptives.
- Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria:
- If previously on a chemoprevention agent or prevention trial, subjects must have completed study participation at least 6 months prior to baseline biomarker assessment.
- If subject has a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen and is either not eligible or is not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy).
Key exclusion criteria (8 listed)
- Women that have had a metastatic malignancy of any kind.
- Women that have had prior invasive breast cancer If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contra-lateral (uninvolved breast) will be studied by FNA. The subject may not have had any radiation therapy to the contra-lateral breast to be studied.
- Women who are pregnant or nursing.
- Women who have taken a SERM, aromatase inhibitor or participated in a chemoprevention or other investigational drug study within six months prior to baseline FNA.
- Women who have used fertility drugs within six months prior to baseline aspiration.
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 |
|---|---|---|
| vitamin D3Also: Maximum D3oral capsules, 10,000 IU per week for 6 months | Drug | high dose vitamin D3 (10,000 IU weekly) |
Primary outcome
Change in Mammographic Breast Density Over Course of Study
Time frame: baseline and 6 months
Change in the percent of the breast area that is considered to be at higher density on mammogram.
2 secondary outcomes
Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.
Time frame: baseline and 6 months
OH Vitamin D Levels in Serum
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Global results only will be published.
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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.
Carol Fabian, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D3 in people with Breast Cancer, run by Carol Fabian, MD 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 16 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 18 Jul 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2014). 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?
Change in Mammographic Breast Density Over Course of Study (time frame: baseline and 6 months). 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 18 Jul 2016.