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 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
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief 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. 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.

Arms:
arm 1: Group/Cohort Label vitamin D3

Interventions: intervention 1: vitamin D3
Intervention descriptions: intervention 1: oral capsules, 10,000 IU per week for 6 months

Protocol document: