Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Neoplasms, Postmenopausal Disorder

Intervention / Treatment
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* Drug: calcitriol
* Drug: Calcitriol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: calcitriol<br>calcitriol supplementation (0.25 mcg 2x/d) | Drug: calcitriol<br>* Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.<br>* Other names: Rocaltrol;Drug: Calcitriol<br>* calcitriol 0.25 mcg PO bid<br>* Other names: Rocaltrol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up for 5 years |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasms, Calcitriol, Postmenopausal, Cell Proliferation, Gene Expression Profiling