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

StatusRecruiting
PhasePhase 2
Started2021-10-22
View on ClinicalTrials.gov ↗
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.

Amendment history 2 changes detected by DataLookout

2026-08-29
notable
Primary completion pushed: 2026-08 → 2026-12
2026-08-29
minor
Completion pushed: 2026-08 → 2026-12
Trial Details
NCT Number NCT04677816
Lead Sponsor Wake Forest University Health Sciences
Collaborators: National Cancer Institute (NCI)
Conditions Triple Negative Breast Cancer, Vitamin D Deficiency, Invasive Breast Cancer
Enrollment 50 participants
Start Date 2021-10-22
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-28