Phase I clinical trial of the combination of eribulin and everolimus in patients with metastatic triple-negative breast cancer

Table 2 Dosing levels and DLTs

Dosing levels	Number	Evaluable	DLT (%)	DLT type
A1: everolimus 5 mg daily; eribulin 1.4 mg/m² days 1 and 8 every 3 weeks	10	8^†	4 (50%)	1 patient: grade3 mucositis 2 patients: grade 4 neutropenia, including one with febrile neutropenia 1 patient: received less than 75% of planned dose of everolimus due to prolonged grade 2 mucositis
A2: everolimus 7.5 mg daily; eribulin 1.4 mg/m² days 1 and 8 every 3 weeks	4	3*	2 (67%)	1 patient: grade 3 hyperglycemia 1 patient: grade 3 mucositis
B1: everolimus 5 mg daily; eribulin 1.1 mg/m² days 1 and 8 every 3 weeks	13	12‡	4 (33%)	2 patients: grade 4 neutropenia 1 patient: grade 3 mucositis 1 patient: did not receive 75% of everolimus due to persisting grade 2 mucositis

^†One patient progressed without completion of the first 2 cycles of therapy, hence unevaluable for DLT; 1 patient did not receive planned dose due to grade 3 hypoglycemia attributed to diabetes
*One patient was found to be HER2+ on repeat biopsy, deem ineligible
^‡One patient was found to be HER2+ on repeat biopsy, deem ineligible

ISSN: 1465-542X