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Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

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ClinicalTrials.gov Identifier: NCT00926315
Recruitment Status : Unknown
Verified October 2012 by Eduardo Carneiro de Lyra, University of Sao Paulo General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 23, 2009
Last Update Posted : November 1, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Breast Neoplasms Postmenopausal Disorder Drug: calcitriol Drug: Calcitriol

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients
Study Start Date : July 2007
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Rocaltrol
Drug: Calcitriol
calcitriol 0.25 mcg PO bid
Other Name: Rocaltrol


Outcome Measures

Primary Outcome Measures :
  1. Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Follow-up for 5 years [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

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 ( Registry Identifier: Comissão Ética para Análise Projetos Pesquisa HCFMUSP 626/06 )
FAPESP 07/04799-2 ( Other Grant/Funding Number: Fundação de Amparo à Pesquisa Estado de São Paulo 07/04799-2 )
IBCC 108/2006/07 ( Registry Identifier: Comitê de Ética em Pesquisa IBCC 108/2006/07 )
CAPPesq 0018/09 ( Registry Identifier: Comissão Ética para Análise Projetos Pesquisa HCFMUSP )
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by Eduardo Carneiro de Lyra, University of Sao Paulo General Hospital:
Breast Neoplasms
Calcitriol
Postmenopausal
Cell Proliferation
Gene Expression Profiling

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vitamin D
Calcitriol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents