Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib and Letrozole in Hormone Receptor Positive Breast Cancer
University of Texas Southwestern Medical Center
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
INCLUSION CRITERIA: * Clinical stage operable stage I, II, or III invasive mammary carcinoma, which is estrogen receptor or progesterone receptor positive by immunohistochemistry and HER2 negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing. * Have post-menopausal status, as defined by any of the following: Subjects at least 55 years of age OR Subjects under 55 years of age and amenorrheic for at least 12 months OR follicule stimulating hormone (FSH) values ≥ 40 IU/L and estradiol levels ≤ 40 pg/mL (140 pmol/L) or in postmenopausal ranges…
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 HospitalDallas, Texas
- University of Texas Southwestern Medical CenterDallas, Texas