NCT05064085

Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer

A Phase I Trial of Capecitabine in Combination With Cemiplimab in Patients With Hormone Receptor Positive Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, phase I study to assess the safety and efficacy of the oral chemotherapy capecitabine in combination with cemiplimab in patients with hormone-receptor-positive (HR+) metastatic breast cancer.

Conditions

• Hormone Receptor-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab	Participants will be given Cemiplimab 350 mg IV day 1 every 21 days
DRUG	Capecitabine	Participants will take Capecitabine at 2 dose levels: 800 mg/m\^2 and 1000 mg/m\^2 by mouth twice daily 14 days on, 7 days off starting on day 3 every 21 days.

Timeline

• Start date: 2021-10-12
• Primary completion: 2024-09-09
• Completion: 2025-03-13
• First posted: 2021-10-01
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study