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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: United States Department of Defense
• Treatments: Calcipotriene; Ergocalciferols; Vitamin D; Vitamins

Criteria

INCLUSION CRITERIA:

• 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.

EXCLUSION CRITERIA:

• 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