NCT04614194

Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib

Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib and Letrozole in Hormone Receptor Positive Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Letrozole	Oral. Tablets should be taken at the same times every day, with or without food.
DRUG	Abemaciclib	Oral. Tablets should be taken at the same times every day, with or without food.

Timeline

• Start date: 2021-04-15
• Primary completion: 2026-04-15
• Completion: 2028-04-15
• First posted: 2020-11-03
• Last updated: 2025-06-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study