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.
For general information, see Learn About Clinical Studies.
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 September 18, 2014
Neoplasms by Site
Physiological Effects of Drugs
Bone Density Conservation Agents