Trial | NCT00926315  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    calcitriol ...

  • Study Participants

    60
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.
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 Started
Jul 31
2007
Primary Completion
Jun 30
2013
Anticipated
Study Completion
Dec 31
2013
Anticipated
Last Update
Nov 01
2012
Estimate

Drug calcitriol

Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.

  • Other names: Rocaltrol

Drug Calcitriol

calcitriol 0.25 mcg PO bid

  • Other names: Rocaltrol

calcitriol Experimental

calcitriol supplementation (0.25 mcg 2x/d)

Criteria 

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
No Results Posted