Development of Vitamin D as a Therapy for Breast Cancer - Phase II
This study has been completed.
Information provided by (Responsible Party):
Melinda Telli, Stanford University
First received: April 4, 2008
Last updated: July 24, 2013
Last verified: July 2013
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.
Drug: Vitamin D
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Development of Vitamin D as a Therapy for Breast Cancer - Phase II
Primary Outcome Measures:
- Gene expression profile in BCa specimens post Vit D Rx to see if profile is modified by Vit D Rx [ Time Frame: Single point in time, at point of definifite breast cancer surgery, typically 10 days to 4 weeks post diagnosis. ] [ Designated as safety issue: No ]
- Gene expression profile in BCa specimens post Vit D Rx to see if profile is modified by Vit D Rx [ Time Frame: Will vary as tests are performed as tissue samples become available ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
No Intervention: normal biopsy
No Intervention: Normal Vitamin D Level
Experimental: Vitamin D
Drug: Vitamin D
2000, 4000, and 6000 IU, oral
Other Name: disambiguation
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Women undergoing core needle biopsy for a breast abnormality suspicious for breast cancer. Women who have undergone a core needle biopsy demonstrating breast cancer who have not yet had any further therapy are also eligible so long as their core needle biopsy is available for analysis.
- No prior therapy for breast cancer.
- Age 18 years or older.
- Ability to understand and the willingness to sign a written informed consent document.
- Signed informed consent
- 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 (e.g. calcium citrate with vitamin D) within the prior 6 months.
- History of renal failure requiring dialysis or kidney transplantation.
- Women who are known to be pregnant or who are nursing. (As vitamin D does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.)
- Supplemental calcium greater than 600 mg calcium per day during study.
- Patients for who initial treatment of their breast cancer will not be with breast conserving surgery or mastectomy.
- Patients with locally advanced breast cancer
- Patients planned for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy.
- Patients planned for preoperative radiation therapy.
- Patients with planned surgical therapy of their breast cancer that would 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00656019
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
||Melinda Telli, MD
No publications provided
||Melinda Telli, Assistant Professor, Stanford University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 4, 2008
||July 24, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 31, 2015
Bone Density Conservation Agents
Physiological Effects of Drugs