Phase II study of eribulin in combination with gemcitabine for the treatment of patients with locally advanced or metastatic triple negative breast cancer (ERIGE trial). Clinical and pharmacogenetic results on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC).

ABSTRACT:

Background

The combination of a microtubule inhibitor (eribulin) with a nucleoside analog (gemcitabine) may synergistically induce tumor cell death, particularly in triple negative breast cancer (TNBC) characterized by high cell proliferation, aggressive behavior, and chemo-resistance.

Patients and methods

This is an open-label, multicenter phase II study evaluating the combination of eribulin (0.88 mg/m²) plus gemcitabine (1000 mg/m²) on days 1 and 8 of a 21-day cycle as either first- or second-line treatment of locally advanced or metastatic TNBC. The primary endpoint was the objective response for evaluable patients. A prospective, molecular correlative study was carried out to assess the role of germinal BRCA pathogenic variants and single nucleotid

SUBMITTER: Pellegrino B 

PROVIDER: S-EPMC7808100 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature