RecruitingPhase 2NCT04614194

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


Sponsor

University of Texas Southwestern Medical Center

Enrollment

60 participants

Start Date

Apr 15, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how the immune system responds to a treatment called abemaciclib (a CDK4/6 inhibitor) given before surgery in women with early-stage hormone receptor-positive, HER2-negative breast cancer. It is a research study collecting tissue samples — not testing a new drug. **You may be eligible if...** - You are post-menopausal (aged 55 or older, or have stopped menstrual periods for at least 12 months, or have confirmed hormonal post-menopausal status) - You have operable Stage I, II, or III breast cancer that is estrogen or progesterone receptor-positive and HER2-negative - Your breast tumor is at least 1 cm and accessible for biopsy before and after treatment **You may NOT be eligible if...** - You are pre-menopausal - You have HER2-positive or triple-negative breast cancer - You have other conditions that would prevent participation in the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLetrozole

Oral. Tablets should be taken at the same times every day, with or without food.

DRUGAbemaciclib

Oral. Tablets should be taken at the same times every day, with or without food.


Locations(2)

Parkland Hospital

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT04614194


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