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A Phase II, Open-label, Multicenter, Translational Study for Biomarkers of Eribulin Mesylate: Evaluation of the Utility of Monitoring Epithelial-to-Mesenchymal Transition (EMT) Markers on Tumor Cells in the Malignant Plural Effusion of Patients with Metastatic Breast Cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Metastatic Breast Cancer
Date of first enrollment	2016/04/13
Target sample size	48
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Eribulin will be administered at 1.4 mg/m2 on Days (D) 1 and 8 for a 3-week cycle (C) until disease progression or appearance of unmanageable side effect. Concurrent use of anti-HER2 monoclonal antibody will be allowed.

Outcome(s)

Primary Outcome	Changes in EMT/MET marker expression between pre- and post-treatment
Secondary Outcome	Relationship between these changes and the clinical outcome: clinical benefit rate, progression-free survival, and overall survival,

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	1) History of eribulin therapy 2) Pregnant, lactating or woman not agree with contraception within the study period 3) CNS metastasis with symptom or require treatment 4) Active infection excluding well-controlled chronic hepatitis B infection