Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Postmenopausal Disorder; Breast Neoplasms

Treatments: Drug: Calcitriol; Drug: calcitriol

Study type: Interventional

Funder types: Other

Identifiers

NCT00926315

IBCC 108/2006/07 (Registry Identifier)

CAPPesq 626/06 (Registry Identifier)

FMUSPIBCCVD2009

FAPESP 07/04799-2 (Other Grant/Funding Number)

CAPPesq 0018/09 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

calcitriol

Experimental group

Description:

calcitriol supplementation (0.25 mcg 2x/d)

Treatment:

Drug: calcitriol