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A Phase II Study of Eribulin Evaluating Efficacy and Safety as first or secondary line chemotherapy for advanced or metastatic breast cancer without HER2 overexpressing

Not Applicable
Conditions
Advanced or metastatic breast cancer
Registration Number
JPRN-UMIN000009568
Lead Sponsor
General and Gastroenterological Surgery, Osaka Medical College
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
35
Inclusion Criteria

Not provided

Exclusion Criteria

1. serious complication or past history: with symptomatic heart failure, ischemic heart disease within 6 months, liver cirrhosis, psychological disorder treated by antipsychotic drug, uncontrolable diabetes, etc 2. active infection 3. The anamnesis of the hypersensitivity to Eribulin 4. peripheral neuropathy greater than Grade 3 5. male breast cancer 6. under pregnancy or breast-feeding, and possibility (will) of pregnancy. 7. with doctors decision for exclusion

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Objective Response Rate
Secondary Outcome Measures
NameTimeMethod
Duration of Response, Progression free survival, Overall survival, Safety, QO
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