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NCT04677816 · ClinicalTrials.gov registry record · Phase 2
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients
A Phase 2 study of Triple Negative Breast Cancer and Vitamin D Deficiency, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04677816 is a Phase 2 study of Triple Negative Breast Cancer and Vitamin D Deficiency that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 50 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04677816, a Phase 2 study of Triple Negative Breast Cancer and Vitamin D Deficiency, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DRUG Standard of Care Neoadjuvant Chemotherapy (NAC)
- DIETARY_SUPPLEMENT Vitamin D3
- OTHER Drug Diary
Study Locations (1)
North Carolina
- Wake Forest Baptist Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-10-22 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04677816
The ClinicalTrials.gov registry entry for NCT04677816 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (80% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care Neoadjuvant Chemotherapy (NAC) is the first listed.
NCT04677816 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04677816 about?
NCT04677816 is a clinical study titled "Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients". 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 d...
What is the current status of trial NCT04677816?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2021-10-22. Estimated completion is 2026-08.
What conditions does trial NCT04677816 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer, Vitamin D Deficiency, Invasive Breast Cancer.
What interventions are being tested in trial NCT04677816?
The interventions under investigation include: Standard of Care Neoadjuvant Chemotherapy (NAC) (DRUG), Vitamin D3 (DIETARY_SUPPLEMENT), Drug Diary (OTHER).
Who is sponsoring clinical trial NCT04677816?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04677816 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.