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Table 2 Dosing levels and DLTs

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

Dosing levelsNumberEvaluableDLT (%)DLT type
A1: everolimus 5 mg daily; eribulin 1.4 mg/m2 days 1 and 8 every 3 weeks1084 (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 weeks43*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 weeks1312‡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
  1. 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
  2. *One patient was found to be HER2+ on repeat biopsy, deem ineligible
  3. One patient was found to be HER2+ on repeat biopsy, deem ineligible