NCT06678269

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer
• Stage IV Breast Cancer
• Breast Cancer
• Breast Cancer Stage IV
• Breast Cancer Metastatic
• HER2-negative Breast Cancer
• HER2 Negative Breast Carcinoma
• Hormone-receptor-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Abemaciclib	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
RADIATION	Radiation Therapy	27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed entirely within 28 days of simulation via stereotactic body radiotherapy (SBRT).

Timeline

• Start date: 2024-11-15
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2024-11-07
• Last updated: 2026-02-12

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study