RecruitingPhase 1NCT06678269

A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

28 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Cancer Metastatic Metastatic Breast Cancer HER2-negative Breast Cancer Stage IV Breast Cancer Breast Cancer Stage IV

Summary

The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining abemaciclib — a pill used to treat hormone-positive breast cancer — with ablative (high-dose, targeted) radiation to a bone metastasis can boost the immune response and improve outcomes in people with metastatic breast cancer. **You may be eligible if...** - You are 18 or older with confirmed stage IV (metastatic) breast cancer - Your cancer is estrogen receptor-positive and HER2-negative - You have a bone metastasis that is planned for high-dose targeted radiation (SBRT) - Your overall health is adequate for treatment **You may NOT be eligible if...** - Your cancer is HER2-positive or triple-negative - You have uncontrolled brain metastases - Your bone marrow function is severely compromised - You have had prior CDK4/6 inhibitor treatment that you cannot continue - You are pregnant or breastfeeding 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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Interventions

DRUGAbemaciclib

The dose escalation portion of the study, a 3+3 design will be used. Once the MTD of Abemaciclib is reached, the phase Ib expansion portion will enroll up to 10 additional patients also requiring palliation to bone metastases

RADIATIONRadiation Therapy

27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed entirely within 28 days of simulation via stereotactic body radiotherapy (SBRT).