Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

NCT00926315 | Unknown

• 5 other identifiers: FMUSPIBCCVD2009CAPPesq 626/06FAPESP 07/04799-2IBCC 108/2006/07CAPPesq 0018/09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms; Postmenopausal Disorder

Keywords

Breast Neoplasms; Calcitriol; Postmenopausal; Cell Proliferation; Gene Expression Profiling

Outcome Measures

Primary Outcomes (1)

• Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile

  30 days

Secondary Outcomes (1)

• Follow-up for 5 years

  5 years

Study Arms (1)

calcitriol

EXPERIMENTAL

calcitriol supplementation (0.25 mcg 2x/d)

Drug: calcitriol

Interventions

Calcitriol DRUG

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

Also known as: Rocaltrol

calcitriol

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Instituto Brasileiro de Controle do Cancer: collaborator

Study Sites (1)

Instituto Brasileiro de Controle do Câncer - IBCC

São Paulo, São Paulo, 03102-002, Brazil

Location

Related Publications (7)

• 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.

  PMID: 16828283 BACKGROUND

• 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.

  PMID: 15544934 BACKGROUND

• 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.

  PMID: 12648525 BACKGROUND

• 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.

  PMID: 11743608 BACKGROUND

• 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.

  PMID: 9744516 BACKGROUND

• 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.

  PMID: 18534255 BACKGROUND

• 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.

  PMID: 16243817 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Hyperplasia

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Maria Aparecida A Koike Folgueira, MD,PhD

  Faculdade de Medicina - Universidade de São Paulo

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 23, 2009
• Study Start: July 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

BR (1)