Breast Cancer Clinical Trial
Official title:
Phase IIB Randomized Controlled Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer
RATIONALE: Cholecalciferol may prevent breast cancer in premenopausal women.
PURPOSE: This randomized phase II trial is studying how well cholecalciferol works in
preventing breast cancer in premenopausal women.
OBJECTIVES:
- To assess whether mammographic density is reduced in premenopausal women at high risk of
breast cancer taking high-dose vitamin D3 (oral cholecalciferol 20,000 IU weekly) vs
placebo for 1 year.
- To assess whether proliferation as measured by Ki-67 staining of breast epithelial cells
is reduced in women receiving these treatments.
- To explore the difference in the expression of other biomarkers (including cleaved
caspase-3 [apoptosis marker], ER, vitamin D receptor [VDR], and 1α-hydroxylase) in
breast tissue obtained from these women.
- To assess whether parathyroid hormone, IGF-1, IGFBP-3, 25(OH)D, and 1,25(OH)D serum
levels are altered in these women at baseline and at 6 and 12 months.
- To explore whether a change in mammographic density correlates with polymorphisms in the
VDR gene.
- To assess other sources of vitamin D (sunlight exposure, diet) in these women using a
validated questionnaire administered at baseline and at 12 and 24 months.
- To collect and bank serum, plasma, and breast tissue from these women before and after a
1-year intervention with vitamin D for future biomarker analysis.
- To assess the toxicity of high-dose cholecalciferol compared to placebo in this setting.
OUTLINE: This is a multicenter study. Participants are stratified according to baseline serum
25(OH)D level (< 20 ng/mL vs 20-32 ng/mL or < 50 nmol/L vs 50-80 nmol/L), baseline
mammographic density (11-50% vs > 50%), and designated biopsy site (yes vs no). Participants
are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive oral cholecalciferol once weekly and oral vitamin D once
daily. Treatment repeats for 12 months in the absence of evidence of cancer or
unacceptable toxicity.
- Arm II: Participants receive oral placebo once weekly and oral vitamin D once daily.
Treatment repeats for 12 months in the absence of evidence of cancer or unacceptable
toxicity.
Blood samples are collected at baseline and periodically thereafter for biomarkers and
25(OH)D level. Participants undergo a mammogram at baseline and at 12 months. Participants
may also undergo random core-needle breast biopsy at baseline and at 12 months.
Participants complete a questionnaire at baseline and at 12 and 24 months.
After completion of study therapy, participants are followed up at 1 and 12 months.
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