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
Phase 2
Recruiting
- Conditions
- Metastatic Breast Cancer
- Registration Number
- JPRN-UMIN000022362
- Lead Sponsor
- Shizuoka Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in EMT/MET marker expression between pre- and post-treatment
- Secondary Outcome Measures
Name Time Method Relationship between these changes and the clinical outcome: clinical benefit rate, progression-free survival, and overall survival,