Overview

This trial is active, not recruiting.

Conditions breast neoplasms, postmenopausal disorder
Treatments calcitriol
Sponsor University of Sao Paulo General Hospital
Collaborator Instituto Brasileiro de Controle do Cancer
Start date July 2007
End date June 2013
Trial size 60 participants
Trial identifier NCT00926315, CAPPesq 0018/09, CAPPesq 626/06, FAPESP 07/04799-2, FMUSPIBCCVD2009, IBCC 108/2006/07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
calcitriol supplementation (0.25 mcg 2x/d)
calcitriol Rocaltrol
Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.
calcitriol Rocaltrol
calcitriol 0.25 mcg PO bid

Primary Outcomes

Measure
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile
time frame: 30 days

Secondary Outcomes

Measure
Follow-up for 5 years
time frame: 5 years

Eligibility Criteria

Female participants from 40 years up to 70 years old.

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

Additional Information

Official title Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients
Principal investigator Eduardo Carneiro de Lyra, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.