Background: Alteration of the PI3K/AKT/mTOR pathway is a common genomic abnormality detected in triplenegative\nbreast cancer (TNBC). Everolimus acts synergistically with eribulin in TNBC cell lines and xenograft models.\nThis phase I trial was designed to test the safety and tolerability of combining eribulin and everolimus in patients\nwith metastatic TNBC.\nMethods: The primary objective of this study was to evaluate the safety and toxicities of the combination. Patients\nwith metastatic TNBC who had up to four lines of prior chemotherapies were enrolled. The combination of eribulin\nand everolimus was tested using three dosing levels: A1 (everolimus 5 mg daily; eribulin 1.4 mg/m2 days 1 and 8\nevery 3 weeks), A2 (everolimus 7.5 mg daily; eribulin 1.4 mg/m2, days 1 and 8 every 3 weeks), and B1 (everolimus 5\nmg daily; eribulin 1.1 mg/m2 days 1 and 8 every 3 weeks).\nResults: Twenty-seven patients with median age 55 years were enrolled. Among 8 evaluable patients who received\ndose level A1, 4 had dose-limiting toxicities (DLTs). Among 3 evaluable patients treated with dose level A2, 2 had\nDLTs. Among 12 evaluable patients who received dose level B1, 4 had DLTs. The DLTs were neutropenia, stomatitis,\nand hyperglycemia. ................................
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