Trials / Completed
CompletedNCT04352777
Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer
Evaluation of the Effects of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abemaciclib | 50 - 150mg tablet BID as prescribed per standard of care |
| DRUG | Fulvestrant | 500mg as prescribed per standard of care |
| DRUG | Aromatase Inhibitors | Letrozole, anastrozole as prescribed per standard of care |
Timeline
- Start date
- 2020-09-14
- Primary completion
- 2025-06-25
- Completion
- 2025-06-25
- First posted
- 2020-04-20
- Last updated
- 2025-07-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04352777. Inclusion in this directory is not an endorsement.