OncoMatch/Clinical Trials/NCT04614194
Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib
Is NCT04614194 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Letrozole and Abemaciclib for breast cancer.
Treatment: Letrozole · Abemaciclib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 positive
estrogen receptor or progesterone receptor positive by immunohistochemistry
Required: PR (PGR) positive
estrogen receptor or progesterone receptor positive by immunohistochemistry
Required: HER2 (ERBB2) wild-type (Herceptest (0 or 1+) or not amplified by in situ hybridization)
HER2 negative by Herceptest (0 or 1+) or not amplified by in situ hybridization
Disease stage
Required: Stage I, II, III
Clinical stage operable stage I, II, or III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: chemotherapy
Chemotherapy ... for current diagnosis of breast cancer
Cannot have received: radiotherapy
Radiotherapy ... for current diagnosis of breast cancer
Cannot have received: any other cancer therapy
any other cancer therapy for current diagnosis of breast cancer
Cannot have received: investigational agents
Subjects may not have received or be receiving any other investigational agents for the treatment of the cancer under study
Lab requirements
Blood counts
anc ≥1,500/mcl, platelets ≥100,000/mcl, hemoglobin ≥8 g/dl
Kidney function
creatinine clearance >30 ml/minute
Liver function
total bilirubin ≤1.5 × upper limit of normal, alt and ast ≤3 × upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Parkland Hospital · Dallas, Texas
- University of Texas Southwestern Medical Center · Dallas, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04614194 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR positive is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify