Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients
40 Years
70 Years
Female
Breast Neoplasms, Postmenopausal Disorder
Trial Information
Influence of Vitamin D on 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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile
Outcome Time Frame:
30 days
Safety Issue:
No
Principal Investigator
Maria Aparecida A Koike Folgueira, MD,PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Faculdade de Medicina - Universidade de São Paulo
Authority:
Brazil: National Committee of Ethics in Research
Study ID:
FMUSPIBCCVD2009
NCT ID:
NCT00926315
Start Date:
July 2007
Completion Date:
December 2013
Related Keywords:
- Breast Neoplasms
- Postmenopausal Disorder
- Breast Neoplasms
- Calcitriol
- Postmenopausal
- Cell Proliferation
- Gene Expression Profiling
- Breast Neoplasms
- Neoplasms
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