Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
Drug: Calcitriol
calcitriol 0.25 mcg PO bid
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile [30 days]
Secondary Outcome Measures
- Follow-up for 5 years [5 years]
Eligibility Criteria
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:
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History of hypercalcemia or nephrolithiasis
-
Current use of corticosteroids, vitamin D supplementation, HRT
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Previous chemotherapy, hormonotherapy or radiotherapy
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Parathyroid disease
-
Absence of clinical condition to receive supplementation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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. doi: 10.1016/j.brainresbull.2008.01.002. Epub 2008 Feb 5.
- 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.
- 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.
- FMUSPIBCCVD2009
- CAPPesq 626/06
- FAPESP 07/04799-2
- IBCC 108/2006/07
- CAPPesq 0018/09