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

ABSTRACT:

Background

Alteration of the PI3K/AKT/mTOR pathway is a common genomic abnormality detected in triple-negative breast cancer (TNBC). Everolimus acts synergistically with eribulin in TNBC cell lines and xenograft models. This phase I trial was designed to test the safety and tolerability of combining eribulin and everolimus in patients with metastatic TNBC.

Methods

The primary objective of this study was to evaluate the safety and toxicities of the combination. Patients with metastatic TNBC who had up to four lines of prior chemotherapies were enrolled. The combination of eribulin and everolimus was tested using three dosing levels: A1 (everolimus 5 mg daily; eribulin 1.4 mg/m² days 1 and 8 every 3 weeks), A2 (everolimus 7.5 mg daily; eribulin 1.4 mg/m²,

SUBMITTER: Lee JS 

PROVIDER: S-EPMC6839083 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature