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

NCT04614194 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-02

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Cancer Prevention Research Institute of Texas

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Sangeetha Reddy, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2026-04-15
Completion
2028-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614194 on ClinicalTrials.gov