HER2-negative metastatic breast cancer
Conditions
Interventions
To reintroduce Eribulin for Metastatic Breast Cancer patients who received prior Eribulin treatment and had effect
Sponsors
Toho university
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1,Pathologically confirmed primary breast cancer 2,Inoperable or recurrent breast cancer 3,HER2-negative by IHC or FISH 4,ECOG performance status 0-2 at the registration 5,Metastatic Breast Cancer patients who received prior Eribulin treatment and had effect(SD or more) 6,Patients at least 1 year after prior Eribulin treatment 7,Patients with measurable lesions 8,Patients in whom the major organ functions have been maintained (The criteria listed below are all met within 14 days before enrollment) Neutrophil count: At least 1,500/mm3 Platelet count: At least 75,000 mm3 Hemoglobin: At least 8.0 g/dL Total bilirubin: Not exceeding 2.0 mg/dL AST and ALT: Under 100 IU/L(Under 300 IU/L for patients who has hepatic metastasis) 9,Age of 20-75 years 10,Duration of survival is expected more than 3 months 11,Patients from whom written consent for participation in the study has been obtained in person
Exclusion criteria
Exclusion criteria: 1.Patient with active infection 2.Pregnant, lactating, or intends to become pregnant 3.brain metastasis with clinical symptoms 4.Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival(retreatment of Eribulin) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate and Safety | — |
Countries
Japan
Contacts
Public ContactFumi Saito
Toho University Omori Medical Center Breast and Endocrine Surgery
Outcome results
None listed