Title: A phase I trial of capecitabine in combination with cemiplimab in patients with hormone receptor-positive metastatic breast cancer

Principal Investigator: Hung T. Khong, MD, of Moffitt Cancer Center and Research Institute in Tampa, Florida

Description: Researchers are conducting a phase 1 study to test the safety and efficacy of capecitabine in combination with cemiplimab in patients with hormone receptor (HR)-positive metastatic breast cancer.

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The study has 2 dosing arms. Patients in both arms will receive cemiplimab at 350 mg intravenously on day 1 of each 21-day cycle. 

Patients in the first arm will also receive capecitabine at 800 mg/m2 orally twice daily, 14 days on and 7 days off, starting on day 3 of each cycle. Patients in the second arm will receive capecitabine on the same schedule but at a dose of 1000 mg/m2.

The primary outcome is the recommended phase 2 dose. Secondary outcome measures include objective response rate, clinical benefit rate, and progression-free survival.

To be eligible for this study, patients must be 18 years of age and older. They must have a confirmed diagnosis of HR-positive breast cancer. For a complete list of eligibility criteria, please see the reference.

Status: Recruiting

This study is sponsored by Moffitt Cancer Center in collaboration with Regeneron Pharmaceuticals.


ClinicalTrials.gov. Capecitabine in combination with cemiplimab in patients with metastatic breast cancer. NCT05064085. Accessed November 22, 2022.