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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00656019

Run by

Stanford University

People needed

63

Starts

2008-04-01

Expected to finish

2011-12-01

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing core needle biopsy for a breast abnormality suspicious for breast cancer.
• Has undergone a core needle biopsy demonstrating breast cancer and has not yet had any further therapy, provided the core needle biopsy is available for analysis.
• No prior therapy for breast cancer within the past 5 years.
• 18 years of age or older.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• History of parathyroid disease, hypercalcemia, or kidney stones.
• Supplemental vitamin D other than from a standard multiple vitamin or from standard formulations of calcium and vitamin D (eg, calcium citrate with vitamin D) within the prior 6 months.
• History of renal failure requiring dialysis or kidney transplantation.
• Pregnant or nursing
• Receiving supplemental calcium > 1200 mg calcium per day during study.
• Initial treatment of breast cancer will not be with breast-conserving surgery or mastectomy.
• Locally-advanced breast cancer
• Plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy
• Plans for preoperative radiation therapy
• Plans for breast cancer surgery, and does not allow for at least 10 days of vitamin D intervention.
• Any condition potentially interfering with subjects ability to comply with taking study medication.
• Any medical condition that would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis.
• Current participation in another research study that would increase risk to subject, in the opinion of the investigators

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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