Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation
NCT ID: NCT00926315
Last Updated: 2012-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2007-07-31
2013-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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calcitriol
calcitriol supplementation (0.25 mcg 2x/d)
calcitriol
Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.
Calcitriol
calcitriol 0.25 mcg PO bid
Interventions
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calcitriol
Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.
Calcitriol
calcitriol 0.25 mcg PO bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Current use of corticosteroids, vitamin D supplementation, HRT
* Previous chemotherapy, hormonotherapy or radiotherapy
* Parathyroid disease
* Absence of clinical condition to receive supplementation
40 Years
70 Years
FEMALE
No
Sponsors
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Instituto Brasileiro de Controle do Cancer
OTHER
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Eduardo Carneiro de Lyra
MD, PhD
Principal Investigators
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Maria Aparecida A Koike Folgueira, MD,PhD
Role: STUDY_CHAIR
Faculdade de Medicina - Universidade de São Paulo
Eduardo Carneiro de Lyra, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Brasileiro de Controle do Cancer
Yuri N Urata, MSc
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina da Universidade de São Paulo
Maria Lucia H Katayama, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina da Universidade de São Paulo
Locations
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Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, São Paulo, Brazil
Countries
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References
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de Lyra EC, da Silva IA, Katayama ML, Brentani MM, Nonogaki S, Goes JC, Folgueira MA. 25(OH)D3 and 1,25(OH)2D3 serum concentration and breast tissue expression of 1alpha-hydroxylase, 24-hydroxylase and Vitamin D receptor in women with and without breast cancer. J Steroid Biochem Mol Biol. 2006 Aug;100(4-5):184-92. doi: 10.1016/j.jsbmb.2006.04.009. Epub 2006 Jul 7.
Rozenchan PB, Folgueira MA, Katayama ML, Snitcovsky IM, Brentani MM. Ras activation is associated with vitamin D receptor mRNA instability in HC11 mammary cells. J Steroid Biochem Mol Biol. 2004 Sep;92(1-2):89-95. doi: 10.1016/j.jsbmb.2004.05.007.
Katayama ML, Pasini FS, Folgueira MA, Snitcovsky IM, Brentani MM. Molecular targets of 1,25(OH)2D3 in HC11 normal mouse mammary cell line. J Steroid Biochem Mol Biol. 2003 Jan;84(1):57-69. doi: 10.1016/s0960-0760(03)00004-9.
Bortman P, Folgueira MA, Katayama ML, Snitcovsky IM, Brentani MM. Antiproliferative effects of 1,25-dihydroxyvitamin D3 on breast cells: a mini review. Braz J Med Biol Res. 2002 Jan;35(1):1-9. doi: 10.1590/s0100-879x2002000100001.
Folgueira MA, Federico MH, Katayama ML, Silva MR, Brentani MM. Expression of vitamin D receptor (VDR) in HL-60 cells is differentially regulated during the process of differentiation induced by phorbol ester, retinoic acid or interferon-gamma. J Steroid Biochem Mol Biol. 1998 Aug;66(4):193-201. doi: 10.1016/s0960-0760(98)00041-7.
Janjoppi L, Katayama MH, Scorza FA, Folgueira MA, Brentani M, Pansani AP, Cavalheiro EA, Arida RM. Expression of vitamin D receptor mRNA in the hippocampal formation of rats submitted to a model of temporal lobe epilepsy induced by pilocarpine. Brain Res Bull. 2008 Jul 30;76(5):480-4. doi: 10.1016/j.brainresbull.2008.01.002. Epub 2008 Feb 5.
Folgueira MA, Carraro DM, Brentani H, Patrao DF, Barbosa EM, Netto MM, Caldeira JR, Katayama ML, Soares FA, Oliveira CT, Reis LF, Kaiano JH, Camargo LP, Vencio RZ, Snitcovsky IM, Makdissi FB, e Silva PJ, Goes JC, Brentani MM. Gene expression profile associated with response to doxorubicin-based therapy in breast cancer. Clin Cancer Res. 2005 Oct 15;11(20):7434-43. doi: 10.1158/1078-0432.CCR-04-0548.
Other Identifiers
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CAPPesq 626/06
Identifier Type: REGISTRY
Identifier Source: secondary_id
FAPESP 07/04799-2
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IBCC 108/2006/07
Identifier Type: REGISTRY
Identifier Source: secondary_id
CAPPesq 0018/09
Identifier Type: REGISTRY
Identifier Source: secondary_id
FMUSPIBCCVD2009
Identifier Type: -
Identifier Source: org_study_id