drugset / Trial / NCT05064085
Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer
Phase 1
Completed
13 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Regeneron Pharmaceuticals · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-10-12
- Primary completion
- 2024-09-09
- Completion
- 2025-03-13
Publications
- Results Aixa Elena Soyano Muller et al. Phase I trial of capecitabine with cemiplimab in patients with hormone receptor-positive metastatic breast cancer.. JCO 43, e13082-e13082(2025). DOI:10.1200/JCO.2025.43.16_suppl.e13082
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 800 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Cemiplimab | Monoclonal antibody | 350 mg | Intravenous |