Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients|
- Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Follow-up for 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
calcitriol supplementation (0.25 mcg 2x/d)
Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.
Other Name: RocaltrolDrug: Calcitriol
calcitriol 0.25 mcg PO bid
Other Name: Rocaltrol
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926315
|Instituto Brasileiro de Controle do Câncer - IBCC|
|São Paulo, SP, Brazil, 03102-002|
|Study Chair:||Maria Aparecida A Koike Folgueira, MD,PhD||Faculdade de Medicina - Universidade de São Paulo|
|Principal Investigator:||Eduardo Carneiro de Lyra, MD, PhD||Instituto Brasileiro de Controle do Cancer|
|Principal Investigator:||Yuri N Urata, MSc||Faculdade de Medicina da Universidade de São Paulo|
|Principal Investigator:||Maria Lucia H Katayama, PhD||Faculdade de Medicina da Universidade de São Paulo|