NCT00926315

Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Neoplasms
• Postmenopausal Disorder

Interventions

Type	Name	Description
DRUG	calcitriol	Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.
DRUG	Calcitriol	calcitriol 0.25 mcg PO bid

Timeline

• Start date: 2007-07-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2009-06-23
• Last updated: 2012-11-01

Locations

1 site across 1 country: Brazil