Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients

Recruiting Phase 2 Interventional Study
Triple Negative Breast Cancer Vitamin D Deficiency Invasive Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Wake Forest University Health Sciences · Other
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Women or men with histologically confirmed invasive mammary carcinoma. * Known triple negative ER/PR/HER2 receptor status as defined by: * ER and PR less than or equal to 10% and * HER2 negative based on one of the following: * IHC 0 or 1+ * IHC 2+ and FISH negative …
Contacts

Study Coordinator

336-713-0031

jwyche@wakehealth.edu

CONTACT