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

NCT ID: NCT00656019

Last Updated: 2017-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-12-31

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal Vitamin D Levels

No additional Vitamin D administered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Low-normal Vitamin D Levels

2000 IU dose of Vitamin D per day administered orally

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

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

Low Vitamin D Levels

4000 IU dose of Vitamin D per day administered orally

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

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

Very-low Vitamin D Levels

6000 IU dose of Vitamin D per day administered orally

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

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

Interventions

Vitamin D

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

Intervention Type: DRUG

Other Intervention Names

Calcipotriene

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Melinda Telli

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melinda Telli, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

98671

Identifier Type: OTHER

Identifier Source: secondary_id

BRSNSTU0026

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-12226

Identifier Type: -

Identifier Source: org_study_id