OncoMatch/Clinical Trials/NCT06139107
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
Is NCT06139107 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Abemaciclib and Letrozole for breast cancer.
Treatment: Abemaciclib · Letrozole — This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to assess the benefits of concurrent use of these treatments in a specific participant population, focusing on their safety and tolerability. The hypothesis is that the combination therapy will be well-tolerated, providing valuable insights into its effectiveness for future clinical applications.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (positive)
Expression of ER or progesterone receptors (PR)
Required: PR (PGR) expression (positive)
Expression of ER or progesterone receptors (PR)
Required: HER2 (ERBB2) negative expression (negative)
negative expression of HER2 per American Society of Clinical Oncology, (ASCO) Common Alerting Protocol (CAP) guidelines
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: CDK4/6 inhibitor
Prior treatment with CDK4/6 inhibitors
Cannot have received: aromatase inhibitor
Prior treatment with ... aromatase inhibitors
Cannot have received: radiation therapy
History of chest wall or ipsilateral breast radiation
Cannot have received: neoadjuvant chemotherapy
Needs neoadjuvant chemotherapy
Lab requirements
Blood counts
ANC >1.5 x 10/L; Platelets >100 x 10/L; Hemoglobin >8 g/dL (may receive erythrocyte transfusions to achieve this level)
Liver function
Total Bilirubin <1.5 x Upper Limit of Normal (ULN); ALT and AST <3 x ULN
Adequate organ function for all of the following: Absolute Neutrophil (ANC) >1.5 x 10/L Platelets >100 x 10/L Hemoglobin >8 g/dL - May receive erythrocyte transfusions to achieve this level Total Bilirubin <1.5 x Upper Limit of Normal (ULN) Alanine Aminotransferase (ATL) and Aspartate Aminotransferase (AST) <3 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- RWJBarnabas Health Clara Maas Medical Center · Belleville, New Jersey
- Cooperman Barnabas Medical Center · Livingston, New Jersey
- Rutgers Cancer Institute of New Jersey · New Brunswick, New Jersey
- RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset · Somerville, New Jersey
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06139107 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CDK4/6 inhibitor, aromatase inhibitor, radiation therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative expression is a required biomarker for enrollment.
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