drugset / Trial / NCT04352777
Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-09-14
- Primary completion
- 2025-06-25
- Completion
- 2025-06-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abemaciclib | Small molecule | 50 mg | — |
| Comparator | Abemaciclib | Small molecule | 150 mg | — |
| Subject | Anastrozole | Other / unclassified | — | — |
| Comparator | Fulvestrant | Small molecule | 500 mg | — |
| Subject | Letrozole | Other / unclassified | — | — |