Second Line ERIbulin Followed by CApecitabine or the Reverse Sequence in HER2-negative Metastatic Breast Cancer Patients

Summary

GIM22-ERICA is a clinical trial investigating the efficacy of two different strategies in HER2 negative MBC treatment. The study will include MBC patients with histologically documented HER2 negative disease, who have progressed to one prior regimen for metastatic disease and are eligible for a second-line chemotherapy with either eribulin or capecitabine. This study design should answer to different questions: * What is the correct placement of Eribulin in the context of a long term treatment strategy? * Is an early use of Eribulin the best approach for MBC pts treatment? * May early use of Eribulin impact on subsequent treatment outcomes? The correlated biomarkers analysis, evaluating angiogenic, epithelial and mesenchymal markers should confirm the results observed in preclinical studies ad support the clinical findings. Liquid biopsies and ctDNA evaluation could help to monitor the course of the disease and to identify novel biomarkers of drug resistance.

Timeline

Start

2018-07-30

Primary completion

2023-07

Completion

2023-07

Drugs

Indications