Development of Vitamin D as a Therapy for Breast Cancer - Phase 2

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Vitamin D

• Registration Number: NCT00656019
• Lead Sponsor: Stanford University

Brief Summary

This study will assess whether levels of vitamin D impact the characteristics of a woman's breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels of vitamin D changes the gene expression of their breast cancers.

Detailed Description

Patients undergoing core needle biopsy of breast abnormalities suspicious for breast cancer will be identified and enrolled in study. As well as those who have had a core needle biopsy demonstrating breast cancer, but who have not yet undergone local surgical treatment, chemotherapy, or hormonal therapy are also eligible. patients with breast cancer on core biopsy will be eligible.

Participants will be assigned to treatment (0, 2000, 4000, 6000 IU/day vitamin D by mouth) based solely on their serum vitamin D levels (Normal: \>40 ng/mL; Low-normal: 31-40 ng/mL; Low: 20-30 ng/mL; Very-low: \<20 ng/mL). Prior to definitive breast cancer surgery, vitamin D level, parathyroid level, and calcium will be reassessed. Samples of the patients original core biopsy and pathology specimen from their definitive surgical therapy will undergo gene expression profiling.

The ultimate plan is to correlate baseline vitamin D levels with classic prognostic and predictive markers to see if breast cancer biology is impacted by baseline vitamin D level and by vitamin D supplementation and to see if vitamin D supplementation results in gene expression changes similar to those of the vitamin D sufficient group.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-10
• Primary Completion: 2010-08
• Study Completion: 2011-12
• Results First Submitted: 2017-01-31
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-26
• Last Update Submitted: 2017-10-26
• Results First Posted: 2017-12-02
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-normal Vitamin D Levels	Vitamin D	2000 IU dose of Vitamin D per day administered orally
Low Vitamin D Levels	Vitamin D	4000 IU dose of Vitamin D per day administered orally
Very-low Vitamin D Levels	Vitamin D	6000 IU dose of Vitamin D per day administered orally

Primary Outcome Measures

Name	Time	Method
Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer	10 days to 4 weeks post diagnosis.	Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States