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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04614194
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 15, 2021
Status verified
May 2025
Primary completion
Apr 15, 2026
Completion
Apr 15, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm A: Abemaciclib + Letrozole
    Patient will take twice daily abemaciclib and daily letrozole (Arm A) for 2 weeks prior to your planned standard treatment for breast cancer. In addition to tests and procedures that are part of your standard care, you will have a biopsy and blood draw for study purposes prior to starting study treatment.
  • Experimental: Arm B: Letrozole
    Patient will take daily letrozole only (Arm B) according to treatment arm for 2 weeks prior to your planned standard treatment for breast cancer. In addition to tests and procedures that are part of your standard care, you will have a biopsy and blood draw for study purposes prior to starting study treatment.

Primary Outcome Measure

Change in T cell activation [ Time Frame: After treatment ends (14 (+/- 3) days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Parkland HospitalDallasTexas75039-
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Parkland Hospital· Dallas, TXUniversity of Texas Southwestern Medical Center· Dallas, TX

Related Studies