Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Early Stage Breast Cancer and Breast Cancer Invasive, sponsored by University of Illinois at Chicago.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants that show tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer
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 |
What NCT04891068 shows while recruiting
NCT04891068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 412-participant average among 21 other Early Stage Breast Cancer trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Early Stage 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 NCT04891068's enrollment target sits among peer trials
40 18th of 21 higher than 3 of 21 other Early Stage Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Stage 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients
RECRUITING · Phase 2
-
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
RECRUITING · Phase 2
-
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
RECRUITING · Phase 2
-
Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
RECRUITING · Phase 2
-
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
RECRUITING · Phase 2
-
TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI