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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melinda Telli, Stanford University
ClinicalTrials.gov Identifier:
NCT00656019
First received: April 4, 2008
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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. ] [ 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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

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

No publications provided

Responsible Party: Melinda Telli, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00656019     History of Changes
Other Study ID Numbers: BRSNSTU0026, 98671
Study First Received: April 4, 2008
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 23, 2014