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NCT04891068 · ClinicalTrials.gov registry record · Phase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
A Phase 2 study of Early Stage Breast Cancer and Breast Cancer Invasive, sponsored by University of Illinois at Chicago.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04891068 is a Phase 2 study of Early Stage Breast Cancer and Breast Cancer Invasive that is actively recruiting participants, run by University of Illinois at Chicago. The registered enrollment target is 40 participants, below the 412-participant average among 21 other Early Stage Breast Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04891068, a Phase 2 study of Early Stage Breast Cancer and Breast Cancer Invasive, is actively recruiting participants, sponsored by University of Illinois at Chicago.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
To determine the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer, paired t-tests will be first used to compare TIL count in pre- and post-treatment specimens.
Conditions Studied
Interventions
- DRUG Azacitidine
Study Locations (1)
Illinois
- University of Illinois Cancer Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-01-10 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04891068
The ClinicalTrials.gov registry entry for NCT04891068 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 412-participant average among 21 other Early Stage Breast Cancer trials with a reported enrollment target (90% lower). The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Early Stage Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Azacitidine is the first listed.
NCT04891068 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT04891068 about?
NCT04891068 is a clinical study titled "BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer". To determine the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer, paired t-tests will be first used to compare TIL count in pre- and post-treatment specimens.
What is the current status of trial NCT04891068?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-01-10. Estimated completion is 2026-05.
What conditions does trial NCT04891068 study?
This clinical trial studies the following conditions: Early Stage Breast Cancer, Breast Cancer Invasive, High Risk Breast Carcinoma.
What interventions are being tested in trial NCT04891068?
The interventions under investigation include: Azacitidine (DRUG).
Who is sponsoring clinical trial NCT04891068?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04891068 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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