RecruitingPhase 1NCT06139107

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

RADIANT Study: Pre-op Radiation With Abemaciclib Andletrozole in Early Stage Breast Cancer

Sponsor

Mridula George, MD

Enrollment

15 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of pre-surgery radiation therapy with two hormone-type drugs — abemaciclib and letrozole — in post-menopausal women with early-stage, hormone-receptor-positive, HER2-negative breast cancer. The goal is to shrink tumors before surgery and reduce the risk of recurrence. **You may be eligible if...** - You are post-menopausal - You have been diagnosed with early-stage invasive breast cancer (Stage cT1-T2N0) with a tumor at least 1.5 cm that cannot be felt (clinically inapparent) - Your tumor is hormone receptor-positive (ER or PR) and HER2-negative - Your tumor's Oncotype DX recurrence score is less than 25 - Your cancer has not spread to lymph nodes **You may NOT be eligible if...** - You are pre-menopausal - Your tumor is HER2-positive - Your Oncotype DX recurrence score is 25 or higher - Your tumor is palpable or larger than T2 stage - Your cancer has spread to lymph nodes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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