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A Phase I Trial of Capecitabine in Combination with Cemiplimab in Patients with Hormone Receptor Positive Metastatic Breast Cancer
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.
- To evaluate the safety and tolerability of capecitabine in combination with cemiplimab and to determine the recommended phase II dose (RP2D) Secondary Objective: 1. To evaluate the objective response rate (ORR) 2. To evaluate the clinical benefit rate (CBR) 3. To evaluate progression-free survival (PFS)
Cemiplimab (); REGN2810 (Cemiplimab); Xeloda (capecitabine); capecitabine ()
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