- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01166763
Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: high dose vitamin D3 (10,000 IU weekly)
Group/Cohort Label vitamin D3
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oral capsules, 10,000 IU per week for 6 months
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mammographic Breast Density Over Course of Study
Time Frame: baseline and 6 months
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Change in the percent of the breast area that is considered to be at higher density on mammogram.
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baseline and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.
Time Frame: baseline and 6 months
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Change in percent of cells expressing staining for Ki-67 antibody in breast epithelial cell specimens acquird by Random Periareolar Fine Needle Aspiration.
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baseline and 6 months
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OH Vitamin D Levels in Serum
Time Frame: baseline and 6 months
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Assessment of 25(OH)D levels as a measure of circulating vitamin D.
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baseline and 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carol Fabian, MD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Additional relevant MeSH terms:
- Pathologic Processes
- Neoplasms
- vitamin D3
- Breast Neoplasms
- Physiological Effects of Drugs
- Pharmacologic Actions
- Hyperplasia
- chemoprevention
- high risk for breast cancer
- Neoplasms by Site
- Breast Diseases
- breast atypia
- breast epithelial hyperplasia
- Molecular Mechanisms of Pharmacological Action
- random periareolar fine needle aspiration
- RPFNA
- ki-67
- high risk for development of breast cancer
- Antirheumatic Agents
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11657 (Registry Identifier: DAIDS ES Registry Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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