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

NCT00656019 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-1222698671BRSNSTU0026
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Correlation of Vitamin D Levels, Prognostic Factors, and Gene Expression Profile in Patients With Breast Cancer

  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

  10 days to 4 weeks post diagnosis.

Study Arms (4)

Normal Vitamin D Levels

NO INTERVENTION

No additional Vitamin D administered

Low-normal Vitamin D Levels

EXPERIMENTAL

2000 IU dose of Vitamin D per day administered orally

Drug: Vitamin D

Low Vitamin D Levels

EXPERIMENTAL

4000 IU dose of Vitamin D per day administered orally

Drug: Vitamin D

Very-low Vitamin D Levels

EXPERIMENTAL

6000 IU dose of Vitamin D per day administered orally

Drug: Vitamin D

Interventions

Vitamin D DRUG

0, 2000, 4000, and 6000 IU per day orally

Also known as: Calcipotriene

Low Vitamin D Levels; Low-normal Vitamin D Levels; Very-low Vitamin D Levels

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vitamin D; calcipotriene

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Melinda Telli
• Organization: StanfordU

steinhau@stanford.edu

650-724-9533

Study Officials

• Melinda Telli, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2011
• Last Updated: December 2, 2017
• Results First Posted: December 2, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)