Phase 2
N=63
Development of Vitamin D as a Therapy for Breast Cancer - Phase 2
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00656019 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer — 0; 0; 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin D (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer |
0; 0; 0; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00656019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.