Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

Breast Neoplasms Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Neoplasms
• Postmenopausal Disorder

• NCT number: NCT00926315
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2007
• Completion date: December 2013