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

Metastatic Breast Cancer Clinical Trial

Official title: Second Line ERIbulin Followed by CApecitabine or the Reverse Sequence in HER2-negative Metastatic Breast Cancer (MBC) Patients: a Randomized Phase II Study - ERICA Trial

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Patients who are considered eligible for the study treatment, will be randomly allocated within the two study arms.

ARM A:

• Second line Eribulin 1.23 mg/m2 i.v. on day 1, 8 every 21 days

• third line Capecitabine 1250 mg/m2 orally twice per day on days 1 to 14 every 21 days

ARM B:

• Second line Capecitabine 1250 mg/m2 orally twice per day on days 1 to 14 every 21 days

• Third line Eribulin 1.23 mg/m2 i.v. on day 1, 8 every 21 days

Study treatment will be continued until disease progression, death, unacceptable toxicity, Investigator's decision or patient refusal of further treatment. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

• NCT number: NCT05833919
• Study type: Interventional
• Source: Consorzio Oncotech
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 30, 2018
• Completion date: July 2023