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NCT04352777 · ClinicalTrials.gov registry record · Phase 2
Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT04352777 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 18 participants.
The verdict
NCT04352777, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to perform an in depth analysis of changes in the tumor immune microenvironment in patients undergoing treatment with standard of care endocrine therapy and abemaciclib in the advanced setting via singe cell RNA sequencing. The investigators will also correlate changes in serum estrogen levels to changes in tumor and peripheral immune cell repertoire and function (including regulatory T cell populations, B cells, myeloid-derived suppressor cell populations, T cell activation and T cell exhaustion).This study has two cohorts with 15 patients in each cohort.
Interventions
- DRUG Fulvestrant
- DRUG Abemaciclib
- DRUG Aromatase Inhibitors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2025-06-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04352777
The ClinicalTrials.gov registry entry for NCT04352777 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Fulvestrant is the first listed.
NCT04352777 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04352777 about?
NCT04352777 is a clinical study titled "Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer". The purpose of this study is to perform an in depth analysis of changes in the tumor immune microenvironment in patients undergoing treatment with standard of care endocrine therapy and abemaciclib in the advanced setting via singe cell RNA sequencing. The investigators will also correlate changes i...
What is the current status of trial NCT04352777?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2020-09-14. Estimated completion is 2025-06-25.
What interventions are being tested in trial NCT04352777?
The interventions under investigation include: Fulvestrant (DRUG), Abemaciclib (DRUG), Aromatase Inhibitors (DRUG).
Who is sponsoring clinical trial NCT04352777?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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