Actively Recruiting
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
Led by Wake Forest University Health Sciences · Updated on 2026-04-14
50
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
A two arm pilot study investigating the rate of pathologic complete response in patients with vitamin D deficiency and triple negative breast cancer undergoing standard neoadjuvant chemotherapy + vitamin D supplementation, including an observational arm to describe response in patients who are not deficient. Investigators hypothesize that vitamin D supplementation during neoadjuvant chemotherapy in operable triple negative breast cancer patients with vitamin D deficiency, will increase the rate of pathologic complete response chain reaction to that of vitamin D sufficient patients based on historical controls.
CONDITIONS
Official Title
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women or men with confirmed invasive mammary carcinoma
- Triple negative breast cancer defined as ER and PR 10% and HER2 negative by IHC or FISH criteria
- Planning to undergo neoadjuvant chemotherapy before surgery, eligible up to 2 weeks after starting chemotherapy
- ECOG performance status 0, 1, or 2
- Age 18 years or older
- Women of child-bearing potential must agree to use contraception during the study
- Ability to understand and sign informed consent
You will not qualify if you...
- History of kidney stones within the past year
- Known sarcoidosis
- Corrected calcium level above 10.5 mg/dL within 30 days before chemotherapy
- Allergic reactions to vitamin D or related compounds
- Pregnant women
- Breastfeeding women
- Prior treatment for this cancer including surgery, radiation, chemotherapy, hormonal therapy, or investigational agents
- Current use of vitamin D at 50,000 IU once weekly
AI-Screening
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Trial Site Locations
Total: 1 location
1
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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