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

• ClinicalTrials.gov Identifier: NCT00656019
• Recruitment Status: Completed
• First Posted: April 10, 2008
• Results First Posted: December 2, 2017
• Last Update Posted: December 2, 2017
• Sponsor: Stanford University
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): Melinda Telli, Stanford University

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
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: December 2011

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• 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
• Results First Posted: December 2, 2017
• Last Update Posted: December 2, 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; Vitamin D; Vitamins; Breast Diseases; Skin Diseases; Calcipotriene; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Dermatologic Agents