Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

Not Applicable

• Conditions: Breast Neoplasms; Postmenopausal Disorder
• Interventions: Drug: Calcitriol

• Registration Number: NCT00926315
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-22
• Study First Posted: 2009-06-23
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-31
• Last Update Posted: 2012-11-01
• Primary Completion: 2013-06
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Postmenopausal women
• Invasive breast carcinoma
• Clinical conditions for breast surgery
• No previous neoadjuvant treatment for breast cancer
• Agreement to take part in the study and sign the informed consent

Exclusion Criteria

• History of hypercalcemia or nephrolithiasis
• Current use of corticosteroids, vitamin D supplementation, HRT
• Previous chemotherapy, hormonotherapy or radiotherapy
• Parathyroid disease
• Absence of clinical condition to receive supplementation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
calcitriol	Calcitriol	calcitriol supplementation (0.25 mcg 2x/d)

Primary Outcome Measures

Name	Time	Method
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile	30 days

Secondary Outcome Measures

Name	Time	Method
Follow-up for 5 years	5 years

Trial Locations

Locations (1)

Instituto Brasileiro de Controle do Câncer - IBCC; 🇧🇷 São Paulo, SP, Brazil