Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Instituto Brasileiro de Controle do Cancer

Information provided by (Responsible Party):

Eduardo Carneiro de Lyra, University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT00926315

First received: June 19, 2009

Last updated: October 31, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention
Breast Neoplasms Postmenopausal Disorder	Drug: calcitriol Drug: Calcitriol

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menopause Vitamin D

Drug Information available for: Vitamin D Calcitriol

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:

Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Follow-up for 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: calcitriol calcitriol supplementation (0.25 mcg 2x/d)	Drug: calcitriol Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month. Other Name: Rocaltrol Drug: Calcitriol calcitriol 0.25 mcg PO bid Other Name: Rocaltrol

Detailed 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.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926315

Locations

Brazil
Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, SP, Brazil, 03102-002

Sponsors and Collaborators

University of Sao Paulo General Hospital

Instituto Brasileiro de Controle do Cancer

Investigators

Study Chair:	Maria Aparecida A Koike Folgueira, MD,PhD	Faculdade de Medicina - Universidade de São Paulo
Principal Investigator:	Eduardo Carneiro de Lyra, MD, PhD	Instituto Brasileiro de Controle do Cancer
Principal Investigator:	Yuri N Urata, MSc	Faculdade de Medicina da Universidade de São Paulo
Principal Investigator:	Maria Lucia H Katayama, PhD	Faculdade de Medicina da Universidade de São Paulo

More Information

Publications:

de Lyra EC, da Silva IA, Katayama ML, Brentani MM, Nonogaki S, Góes 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. 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.

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.

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. Review.

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.

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. Epub 2008 Feb 5.

Folgueira MA, Carraro DM, Brentani H, Patrão DF, Barbosa EM, Netto MM, Caldeira JR, Katayama ML, Soares FA, Oliveira CT, Reis LF, Kaiano JH, Camargo LP, Vêncio RZ, Snitcovsky IM, Makdissi FB, e Silva PJ, Góes 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.

Responsible Party:	Eduardo Carneiro de Lyra, MD, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:	NCT00926315 History of Changes
Other Study ID Numbers:	FMUSPIBCCVD2009, CAPPesq 626/06, FAPESP 07/04799-2, IBCC 108/2006/07, CAPPesq 0018/09
Study First Received:	June 19, 2009
Last Updated:	October 31, 2012
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:

Breast Neoplasms
Calcitriol
Postmenopausal
Cell Proliferation
Gene Expression Profiling

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Calcitriol
Vitamin D
Vitamins
Micronutrients
Growth Substances

Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013

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