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

40 Years
70 Years
Open (Enrolling)
Breast Neoplasms, Postmenopausal Disorder

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Trial Information

Influence of Vitamin D on 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.

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

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

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Maria Aparecida A Koike Folgueira, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Faculdade de Medicina - Universidade de São Paulo


Brazil: National Committee of Ethics in Research

Study ID:




Start Date:

July 2007

Completion Date:

December 2013

Related Keywords:

  • Breast Neoplasms
  • Postmenopausal Disorder
  • Breast Neoplasms
  • Calcitriol
  • Postmenopausal
  • Cell Proliferation
  • Gene Expression Profiling
  • Breast Neoplasms
  • Neoplasms