Status:
COMPLETED
Development of Vitamin D as a Therapy for Breast Cancer - Phase 2
Lead Sponsor:
Stanford University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 cha...
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00656019
Start Date
April 1 2008
End Date
December 1 2011
Last Update
December 2 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305