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NCT04614194 · ClinicalTrials.gov registry record · Phase 2
Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib
A Phase 2 study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT04614194: Recruiting Phase 2 study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT04614194 is a Phase 2 study of Breast Cancer that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 60 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04614194, a Phase 2 study of Breast Cancer, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to better understand how the immune system plays a role in fighting breast cancer and specifically research if the immune system response against breast cancer can be improved with endocrine therapy and cyclin dependent kinase inhibitor therapy in patients with hormone receptor positive breast cancer. This will be studied by collecting tumor tissue and blood samples before and after 2 weeks of study treatment with commonly used endocrine therapy and cyclin dependent kinase inhibitor therapy.
Primary Outcome
Change in T cell activation between matched pre-treatment and on-treatment tissue samples of responder patients treated with abemaciclib and letrozole. T cell activation will be defined as the density of granzyme positive CD8 T cells detected on multiplex immunohistochemistry. Responders are defined as having complete cell cycle arrest by Ki-67.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Abemaciclib
Study Locations (2)
Texas
- Parkland Hospital - Dallas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-04-15 |
| Est. Completion | 2028-04-15 |
| Phase | Phase 2 |
What NCT04614194 shows while recruiting
NCT04614194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Letrozole is the first listed.
NCT04614194 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04614194 about?
NCT04614194 is a clinical study titled "Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib". The purpose of this study is to better understand how the immune system plays a role in fighting breast cancer and specifically research if the immune system response against breast cancer can be improved with endocrine therapy and cyclin dependent kinase inhibitor therapy in patients with hormone r...
What is the current status of trial NCT04614194?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-04-15. Estimated completion is 2028-04-15.
What conditions does trial NCT04614194 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04614194?
The interventions under investigation include: Letrozole (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT04614194?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04614194 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT04614194's enrollment target sits among peer trials
60 736th of 1224 higher than 468 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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
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