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Development of Vitamin D as a Therapy for Breast Cancer - Phase II

This study has been completed.
United States Department of Defense
Information provided by (Responsible Party):
Melinda Telli, Stanford University Identifier:
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.

Condition Intervention Phase
Breast Cancer Drug: Vitamin D Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Vitamin D as a Therapy for Breast Cancer - Phase II

Resource links provided by NLM:

Further study details as provided by Melinda Telli, Stanford University:

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. ]
  • 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 ]

Enrollment: 56
Study Start Date: April 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

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 (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00656019

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
United States Department of Defense
Principal Investigator: Melinda Telli, MD Stanford University
  More Information

Responsible Party: Melinda Telli, Assistant Professor, Stanford University Identifier: NCT00656019     History of Changes
Other Study ID Numbers: BRSNSTU0026
98671 ( Other Identifier: Stanford University Alternate IRB Approval Number )
Study First Received: April 4, 2008
Last Updated: July 24, 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on August 18, 2017