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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: Recruiting Phase 2 study of Triple Negative Breast Cancer and Vitamin D Deficiency, sponsored by Wake Forest University Health Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Investigators will determine whether the proportion responding (pCR) is less than or equal to 30% or greater than or equal to 60% using a one-stage phase II design. All participants in the intervention group who are evaluable will be included in the analysis. Pathologic complete response, which is also characterized as residual cancer burden 0, is defined as a final surgical pathologic diagnosis of ypT0 ypN0 or ypTis ypN0. Only the vitamin D deficient patients will be included in the primary sta
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 |
What NCT04677816 shows while recruiting
NCT04677816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04677816's enrollment target sits among peer trials
50 75th of 118 higher than 43 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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