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Development of Vitamin D as a Therapy for Breast Cancer - Phase 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00656019
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : December 1, 2017
Last Update Posted : December 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Vitamin D Phase 2

Detailed Description:

Patients undergoing core needle biopsy of breast abnormalities suspicious for breast cancer will be identified and enrolled in study. As well as those who have had a core needle biopsy demonstrating breast cancer, but who have not yet undergone local surgical treatment, chemotherapy, or hormonal therapy are also eligible. patients with breast cancer on core biopsy will be eligible.

Participants will be assigned to treatment (0, 2000, 4000, 6000 IU/day vitamin D by mouth) based solely on their serum vitamin D levels (Normal: >40 ng/mL; Low-normal: 31-40 ng/mL; Low: 20-30 ng/mL; Very-low: <20 ng/mL). Prior to definitive breast cancer surgery, vitamin D level, parathyroid level, and calcium will be reassessed. Samples of the patients original core biopsy and pathology specimen from their definitive surgical therapy will undergo gene expression profiling.

The ultimate plan is to correlate baseline vitamin D levels with classic prognostic and predictive markers to see if breast cancer biology is impacted by baseline vitamin D level and by vitamin D supplementation and to see if vitamin D supplementation results in gene expression changes similar to those of the vitamin D sufficient group.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Vitamin D as a Therapy for Breast Cancer - Phase 2
Study Start Date : April 2008
Primary Completion Date : August 2010
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Normal Vitamin D Levels
No additional Vitamin D administered
Experimental: Low-normal Vitamin D Levels
2000 IU dose of Vitamin D per day administered orally
Drug: Vitamin D
0, 2000, 4000, and 6000 IU per day orally
Other Name: Calcipotriene
Experimental: Low Vitamin D Levels
4000 IU dose of Vitamin D per day administered orally
Drug: Vitamin D
0, 2000, 4000, and 6000 IU per day orally
Other Name: Calcipotriene
Experimental: Very-low Vitamin D Levels
6000 IU dose of Vitamin D per day administered orally
Drug: Vitamin D
0, 2000, 4000, and 6000 IU per day orally
Other Name: Calcipotriene


Outcome Measures

Primary Outcome Measures :
  1. Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer [ Time Frame: 10 days to 4 weeks post diagnosis. ]
    Vitamin D levels in serum were correlated to classic prognostic and predictive factors for breast cancer, and the gene expression profile of breast core biopsy specimens. The outcome is reported as the proportion of subjects with a discernible pattern for expression of the set of 40 evaluated genes


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656019


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

Responsible Party: Melinda Telli, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00656019     History of Changes
Other Study ID Numbers: IRB-12226
98671 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BRSNSTU0026 ( Other Identifier: OnCore Number )
First Posted: April 10, 2008    Key Record Dates
Results First Posted: December 1, 2017
Last Update Posted: December 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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