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

June 19, 2009
October 31, 2012
July 2007
June 2013   (final data collection date for primary outcome measure)
Tumor dimension and proliferation evaluated by ultrasound and Ki67 expression; Tumor gene expression profile [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00926315 on ClinicalTrials.gov Archive Site
Follow-up for 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation
Influence of Vitamin D on Gene Expression Profile of Breast Cancer Samples From Post-menopausal Patients

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Breast Neoplasms
  • Postmenopausal Disorder
  • 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
Experimental: calcitriol
calcitriol supplementation (0.25 mcg 2x/d)
Interventions:
  • Drug: calcitriol
  • Drug: Calcitriol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00926315
FMUSPIBCCVD2009, CAPPesq 626/06, FAPESP 07/04799-2, IBCC 108/2006/07, CAPPesq 0018/09
No
Eduardo Carneiro de Lyra, University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Instituto Brasileiro de Controle do Cancer
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
University of Sao Paulo General Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP