- To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women.
- 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.
- Women with breast density ≥ 25% (correlating with the BIRAD-2 category of "scattered fibroglandular densities" or greater)
- Hormone receptor status not specified
- Premenopausal defined as meeting at least one of the following criteria:
- Have regular menstrual cycles
- Have had at least four cycles in the last six months
- Have had a hysterectomy with ovaries intact and FSH level < 20 IU/L
- Calcium < 10.5 mg/dL
- Not pregnant
- Fertile patients must use effective contraception
- Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible
- Patients with two or more bone fractures in the past five years are not eligible
- Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible
- Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible
- Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible
PRIOR CONCURRENT THERAPY:
- 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 is allowed
- Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry
- 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
- 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
- Patients participating in a concurrent breast cancer chemoprevention trial are not eligible
- No history of breast implants or breast reduction
Last updated: 02/05/2013
NCT ID: NCT01224678