Advanced or metastatic breast cancer
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. histlogically or cytologically confirmed breast cancer 2. advanced or metastatic breast cancer patient treated with Eribulin 3. required baseline laboratory parameters (within 1 weeks before registration) WBC >3,000/mm3 neutrophi > 1,500/mm3 Plt > 100,000/mm3 Hb >9.0g/dL AST <2.0 times ULN and ALT <2.0 times ULN serum creatinine <1.5 time ULN normal cardiac function 4. with life expectancy greater than 3 months 5. written informed consent was obtained
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between change of serum epithelium mesenchymal system marker and clinical response after 3 cycles of Eribulin | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, Duration of Response, Progression free survival, Overall survival, Safety | — |
Countries
Japan
Contacts
Osaka medical college Breast Surgery