Clinical trial · Interventional
Development of Vitamin D as a Therapy for Breast Cancer - Phase 2
NCT00656019CI-TRIAL-00030647completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Normal Vitamin D Levels
- description
- No additional Vitamin D administered
- type
- EXPERIMENTAL
- label
- Low-normal Vitamin D Levels
- description
- 2000 IU dose of Vitamin D per day administered orally
- interventionNames
- Drug: Vitamin D
- type
- EXPERIMENTAL
- label
- Low Vitamin D Levels
- description
- 4000 IU dose of Vitamin D per day administered orally
- interventionNames
- Drug: Vitamin D
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.