Vitamin D and Breast Cancer Biomarkers in Female Patients
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any - 55 |
Updated: | 6/27/2018 |
Start Date: | October 2010 |
End Date: | December 2014 |
Vitamin D and Breast Cancer Biomarkers
RATIONALE: Vitamin D may help prevent breast cancer.
PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in
female patients.
PURPOSE: This randomized clinical trial is studying vitamin D and breast cancer biomarkers in
female patients.
OBJECTIVES:
Primary
- To evaluate change in mammographic density using the Boyd method after one year of
vitamin D supplementation compared to placebo in premenopausal women.
Secondary
- To explore changes in the serum biomarker IGF1 in response to one year of vitamin D or
placebo supplementation in premenopausal women.
- To explore changes in cellular proliferation (atypia and Ki67) in response to one year
of vitamin D or placebo supplementation in premenopausal women.
- To explore correlations between change in breast cancer biomarkers (density, IGF1,
atypia, and Ki67) with each other and with change in vitamin D levels.
- To compare methods of mammographic density analysis.
- To validate a recently developed sunlight questionnaire.
OUTLINE: This is a multicenter study. Patients are stratified according to baseline vitamin D
(sufficient [≥ 30 ng/mL or ≥ 75 mmol/L] vs insufficient [< 30 ng/mL or < 75 mmol/L]) and
institutional random periareolar fine-needle aspiration (RPFNA) status (performs RPFNA vs
does not perform RPFNA). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo once daily for 12 months.
- Arm II: Patients receive oral vitamin D (2000 IU) once daily for 12 months. Tissue and
blood samples are collected at baseline and at 12 months for laboratory biomarker
analysis. Patients also complete questionnaires at baseline and at 12 months.
Primary
- To evaluate change in mammographic density using the Boyd method after one year of
vitamin D supplementation compared to placebo in premenopausal women.
Secondary
- To explore changes in the serum biomarker IGF1 in response to one year of vitamin D or
placebo supplementation in premenopausal women.
- To explore changes in cellular proliferation (atypia and Ki67) in response to one year
of vitamin D or placebo supplementation in premenopausal women.
- To explore correlations between change in breast cancer biomarkers (density, IGF1,
atypia, and Ki67) with each other and with change in vitamin D levels.
- To compare methods of mammographic density analysis.
- To validate a recently developed sunlight questionnaire.
OUTLINE: This is a multicenter study. Patients are stratified according to baseline vitamin D
(sufficient [≥ 30 ng/mL or ≥ 75 mmol/L] vs insufficient [< 30 ng/mL or < 75 mmol/L]) and
institutional random periareolar fine-needle aspiration (RPFNA) status (performs RPFNA vs
does not perform RPFNA). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo once daily for 12 months.
- Arm II: Patients receive oral vitamin D (2000 IU) once daily for 12 months. Tissue and
blood samples are collected at baseline and at 12 months for laboratory biomarker
analysis. Patients also complete questionnaires at baseline and at 12 months.
1. Premenopausal women 55 years of age or younger with regular menstrual cycles (at least
four cycles in the last six months). Women with fewer than 4 menses in the last 6
months or who have had a hysterectomy with ovaries intact will be considered
premenopausal if FSH level < 20.
2. Women with breast density ≥ 25% (scattered fibroglandular densities or greater) are
eligible.
3. Prior Treatment
1. Patients who are currently receiving hormone replacement therapy (estrogen or
progesterone); or are taking tamoxifen or raloxifene are not eligible. Women who
have taken these medications must have stopped for at least 4 months prior to
study entry.
Topical estrogen (eg, transdermal patches and vaginal estrogens) is allowed.
2. Patients who are currently using hormonal contraception, should be taking it for
at least 4 months prior to study entry.
4. Vitamin D Use
1. Patients who are taking regular vitamin D supplementation (above 400 IUs daily)
and refuse or are unable to stop use are not eligible. Women who agree to stop
will need to do so for at least 6 months prior to registration.
2. Patients may not start vitamin D supplementation after registration (regardless
of results of vitamin D testing) but they may continue vitamin D if they are
already taking 400 IUs daily or less and have been taking vitamin D for at least
6 months prior to baseline mammogram.
5. Patients with a history of breast cancer (including DCIS) or ovarian cancer are not
eligible.
6. Patients with a history of breast implants or breast reduction are not eligible.
7. Patients with two or more bone fractures in the past five years are not eligible.
8. Patients with a diagnosis of osteoporosis with physician recommendation for treatment
of low bone mass are not eligible.
9. Patients known to have hyperparathyroid disease or other serious disturbances of
calcium metabolism requiring intervention in the past 5 years are not eligible.
10. Patients with a history of kidney stones (unless documented not to have been a calcium
stone) are not eligible.
11. Patients participating in a concurrent breast cancer chemoprevention trial are not
eligible.
12. Required initial laboratory values - Calcium < 10.5 mg/dL
We found this trial at
104
sites
Illinois CancerCare - Pekin Illinois CancerCare is one of the largest private oncology and hematology...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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200 Hawthorne Lane
Charlotte, North Carolina 28233
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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115 Business loop 70 w
Columbia, Missouri 65203
Columbia, Missouri 65203
(573) 882-2100
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4725 North Federal Highway
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Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Holy Cross Hospital's Michael...
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900 West Faris Road
Greenville, South Carolina 29605
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Greenville Hospital Cancer Center Greenville Health System (GHS) is a public not-for-profit academic healthcare delivery...
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One Medical Center Drive
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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800 NE 10th Street
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(855) 750-2273
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SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
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Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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Columbus, Ohio 43210
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Concord, New Hampshire 03301
Concord, New Hampshire 03301
603-224-2556
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Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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518.926.1000
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250 Cherry St SE
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200 Technology Drive
Hooksett, New Hampshire 03106
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603-622-6484
New Hampshire Oncology - Hematology, PA - Hooksett New Hampshire Oncology-Hematology, PA (NHOH) was founded...
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1007 LINCOLNWAY
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Methodist Estabrook Cancer Center At Methodist Estabrook Cancer Center, we understand how deeply a diagnosis...
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Cancer Treatment Center at Pekin Hospital Since 1913, Pekin Hospital has been dedicated to improving...
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OSF St. Francis Medical Center OSF Saint Francis Medical Center, licensed for 616 beds and...
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