Actively Recruiting
Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib
Led by University of Texas Southwestern Medical Center · Updated on 2025-06-02
60
Participants Needed
2
Research Sites
365 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical stage operable stage I, II, or III invasive mammary carcinoma that is estrogen or progesterone receptor positive and HER2 negative
- Post-menopausal status defined by age 55 or older, or under 55 with amenorrhea for at least 12 months, or FSH 2 40 IU/L and estradiol 40 pg/mL or in postmenopausal ranges
- Breast tumor at least 1 cm in diameter and suitable for tissue sampling before and after treatment
- Planned for surgery as initial therapy with suitable 2 weeks of neoadjuvant endocrine therapy, or planned for neoadjuvant systemic therapy where 2 weeks of endocrine therapy prior to systemic therapy is suitable
- At least 18 years old
- ECOG performance status of 2 or less
- Adequate organ function including ANC 2 1500/mcL, platelets 2 100,000/mcL, hemoglobin 2 8 g/dL, total bilirubin 2 1.5x upper limit normal, ALT and AST 2 3x upper limit normal, creatinine clearance above 30 mL/min
- Able to swallow oral medications
- Prior contralateral breast cancer allowed if no evidence of recurrence
- Discontinued tamoxifen or raloxifene for at least 28 days before enrollment if used
- Stopped hormone replacement therapy at least 7 days before first dose
- Willing and able to sign informed consent
- Female of childbearing potential must have negative pregnancy test within 7 days before first dose and agree to use effective contraception during treatment and 3 weeks after last dose (note: most patients should be post-menopausal)
You will not qualify if you...
- Active metastatic, inflammatory, or locally recurrent breast cancer
- Serious or uncontrolled medical conditions that would prevent participation, including severe lung disease, severe renal impairment, major digestive surgery, or chronic diarrhea grade 2 or higher
- Females who are pregnant, lactating, or premenopausal
- Severe uncontrolled malabsorption or severe malnutrition
- Dementia, altered mental status, or psychiatric conditions preventing informed consent
- Prior chemotherapy, radiotherapy, or other cancer therapy for current breast cancer diagnosis
- Receiving or previously received other investigational cancer treatments
- History of allergic reactions to abemaciclib or similar agents
- Uncontrolled illnesses including active infections, heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting compliance
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Parkland Hospital
Dallas, Texas, United States, 75039
Not Yet Recruiting
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
S
Shahbano Shakeel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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