Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: United States Department of Defense

Stanford Investigator(s):

Intervention(s):

  • Drug: Vitamin D

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Charlene Kranz
6504987977
Not Recruiting