The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients.
Women affected by breast cancer present lower 1,25(OH)2D3 or 25(OH)D3 serum levels than unaffected ones. Calcitriol supplementation may be indicated to post-menopausal women to reduce bone loss. Vitamin D has antiproliferative effects in breast cancer cell lines and breast cancer xenografts. Post-menopausal breast cancer patients will be prescribed calcitriol supplementation, in doses indicated to prevent osteoporosis, while they are submitted to biopsy, staging exams and have their breast surgery scheduled (approximately one month). Tumor dimension and proliferation rate (as determined by Ki67 expression), 25(OH)D3 and/or 1,25(OH)2D3 serum concentration, will be evaluated before and after calcitriol supplementation. Tumor gene expression will be evaluated in samples collected before and after supplementation to analyze the differential profile.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
60
Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.
calcitriol 0.25 mcg PO bid
Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, São Paulo, Brazil
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile
Time frame: 30 days
Follow-up for 5 years
Time frame: 5 years
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