OncoMatch/Clinical Trials/NCT06139107
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
Is NCT06139107 recruiting? Yes, currently enrolling (May 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
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)
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 →
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