Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00926315
• Other study ID #: FMUSPIBCCVD2009
• Secondary ID: CAPPesq 626/06FA
• Status: Active, not recruiting
• Phase: N/A
• First received: June 19, 2009
• Last updated: October 31, 2012
• Start date: July 2007
• Est. completion date: December 2013

Study information

• Verified date: October 2012
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Neoplasms
• Postmenopausal Disorder

Intervention

Drug:
• calcitriol
Post menopausal patients will receive Calcitriol 0.50 mcg PO per day for 1 month.
• Calcitriol
calcitriol 0.25 mcg PO bid

Locations

Country	Name	City	State
Brazil	Instituto Brasileiro de Controle do Câncer - IBCC	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Instituto Brasileiro de Controle do Cancer

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile		30 days	No
Secondary	Follow-up for 5 years		5 years	No