First or second line therapy for advanced or recurrent HER2-positive breast cancer patients who have received taxane and trasutuzumab as adjuvant or recurrent therapy.
Conditions
Sponsors
JBCRG(Japan Breast Cancer Research Group)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed primary breast cancer 2.Age of 18-70 years and expected survival is more than 6months 3.Histologically confirmed HER2-positive breast cancer in primary lesion or metastatic lesion(Score 3+ by IHC or HER2 Positive by FISH or DISH) 4.First or second line therapy of Stage IIIB,IIIC,IV or recurrent breast cancer 5.ECOG performance status(PS) 0 or 1(Allow PS 2 due to bone metastases) 6.Clinically confirmed measurable or unmeasurable metastatic lesion except ascites or effusion alone 7.Experienced prior chemotherapy including trasutuzumab and taxane(Prior pertuzumab allowed to be use) 8.No prior use of eribulin 9.Adequate organ function shown in physical examinations within 14 days prior to enrollment Neutrophil count >=1500/mm3 Platelet count >=75,000/mm3 Hemoglobin >=9.0g/dL Total serum bilirubin <=2.0mg/dL AST and ALT <100IU/L Serum creatinine <=1.5mg/dL 10.No clinical electrocardiographic abnormality 11.Echocardiographic ejection fraction >=55% 12.Subjects who have submitted written informed consent for study entry
Exclusion criteria
Exclusion criteria: 1.Active infection or fever at risk of infection 2.History of serious drug allergies 3.Spontanous serious renal damage or liver dysfunction(jaundice) 4.Iinterstitial pneumonia or pulmonary fibrosis by chest X-ray 5.Large pleural effusion or ascites requiring repeat drainage 6.Concurrent uncontrolled hypertension or diabetes mellitus 7.Systemic administration of steroid drug 8.Pregnant females or females of child-bearing potential 9.Concurrent active other malignancy 10.Metachronous or spontaneous bilateral breast cancer except ductal carcinoma in situ 11.Clinically important mental disorder or history of central nervous system damage 12.Clinically significant central nervous system metastases 13.Concurrent enrollment of other clinical trial 14.History use of eribulin 15.Reccurence in conserving breast or local recurrence that is appropriate therapy to reoperate 16.HBs antigen positive 17.Not suitable for participation with any other reasons (including rapid progression disease, life threatening status if not successfully treated)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival(PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate(RR),Safety,Overall survival(OS),Efficacy after prior use of pertuzumab,Compliance of eribulin, Efficacy of later therapy | — |
Countries
Japan
Contacts
Public ContactJun Fukase
JBCRG (Japan Breast Cancer Research Group) Head Office
Outcome results
None listed