Breast Cancer
Conditions
Interventions
Sponsors
Dept of surgical oncology, Hiroshima university hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed breast cancer. 2) Unresectable metastatic breast cancer. 3)Previously treated with chemotherapeutic regimens including an anthracycline and a taxane first-line chemotherapy 4)Having evaluable disease according to RECIST 5)Prior chemotherapy 0-2 regimens for unresectable metastatic status 6)Having an adequate interval from prior therapy 1.chemotherapy:21days 2.endocrine therapy:7days 3.radiation therapy:14days 4.major surgery:28days 5.minor surgery:14days 6)PS (ECOG) 0-2 7)Eligible patient for eribulin therapy 8)Peripheral neuropathy G1 or G0(experienced peripheral neuropathy caused from previous chemotherapy) 9)Adequate organ functions 1.neutrophil=>1000mm3 2.platelet count=>75000mm3 3.AST,ALT=<2.5 times ULN(<5.0 with liver metastasis) 4.total bilirubin=<1.5 times ULN serum creatinine=<1.5mg/dL 10)Female over 20 years old 11)Obtained written informed consent
Exclusion criteria
Exclusion criteria: 1)Forbidden case to use eribulin 2)Serious bone marrow suppression 3)Allergy to component of eribulin 4)Pregnant or like be pregnant 5)Serious liver or renal disorder 6)Inadequate interval from prior therapy 7)Symptomatic brain metastasis 8)Patient with CNS disease, DM, RA, or bone metastasis (possible involvement peripheral neropathy) 9)Peripheral neuropathy caused from surgery 10)With doctors decision for exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rates of peripheral neuropathy G3(CTCAE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Overall Survival FACT-NTX EQ-5D Safety PNQ | — |
Countries
Japan
Contacts
Public ContactHideo Shigematsu
Hiroshima Unversity Hospital Department of surgical oncology
Outcome results
None listed