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Chemotherapy

Vitamin D Supplementation for Breast Cancer

Phase 2

Recruiting

Led By Emily H Douglas, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18

ECOG performance status of 0, 1 or 2

Must not have

Patients with nephrolithiasis within the past year

Prior treatment for this malignancy including surgery, radiation therapy, chemotherapy, hormonal therapy or investigational agent prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 26 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding vitamin D to standard chemotherapy can improve outcomes in patients with vitamin D deficiency and triple-negative breast cancer.

Who is the study for?

This trial is for adults with triple negative breast cancer who are vitamin D deficient and scheduled for surgery after chemotherapy. They must be in good enough health to participate, agree to use contraception, and have not received prior treatment for their cancer. People with a history of kidney stones, sarcoidosis, high calcium levels, allergies to vitamin D-like compounds or taking high-dose Vitamin D cannot join.

What is being tested?

The study tests if adding Vitamin D3 supplements to standard neoadjuvant chemotherapy improves the rate at which patients achieve complete absence of cancer in the breast tissue after treatment (pathologic complete response), compared to historical rates in patients with sufficient vitamin D.

What are the potential side effects?

While this trial focuses on Vitamin D supplementation alongside chemotherapy, potential side effects may include typical reactions from chemo such as nausea, fatigue, hair loss and increased risk of infection. High doses of Vitamin D can cause issues like bone pain and kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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I have been diagnosed with invasive breast cancer.

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My breast cancer is triple negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had kidney stones in the past year.

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I have had treatments like surgery or chemotherapy for my cancer before joining this study.

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I have been diagnosed with sarcoidosis.

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I am taking 50,000 IU of Vitamin D weekly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 26 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 26 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Pathologic Complete Response (pCR) in Vitamin D Supplementation Group

Secondary study objectives

Change in Fecal Microbiomes

Body Weight Changes

Change in Vitamin D Receptor (VDR) Expression

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vitamin D Supplementation Group - Deficient LevelsExperimental Treatment3 Interventions

Along with standard of care neoadjuvant chemotherapy treatments and procedures, participants will receive oral 50,000 international units of Vitamin D3 supplementation at the initiation of chemotherapy once a week.

Group II: Observational Arm - Vitamin D at Normal LevelsActive Control1 Intervention

Standard of care neoadjuvant chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin D3

2011

Completed Phase 4

~3590

0 / 8Eligibility criteria met