advanced or reccurent breast cancer
Conditions
Interventions
One cycle consists of 4 weeks. Eribulin will be administrated intravenously on day1 and 15. Administration can be continued until the evidence of desease progression or unacceptable toxcity.
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Administrated 1.4mg/m2 on day1 and skipped on day8 due to administration criteria 2)Satisfied administration criteria on day15 3)Female with hisitologically or citologically confirmed breast cancer 4)Aged 20-years when giving informed consent 5)ECOG perfomance status(PS) 0-2 6)With measurable lesion met the RECIST criteria and evaluated baseline within 30days before Eribulin first treatment 7)Have received anthracycline and taxan 8)Have no carryover of efficacy or no adverse drug reactions from previous therapy 9)With adequate function of major organs 10)With an expected survival of >= 3 months from Eribulin first treatment 11)Planed with eribulin monotherapy 12)Have given wriiten voluntary concent for participation in this study
Exclusion criteria
Exclusion criteria: 1)Systemic infection 2)Dirrea, ileus 3)GI bleeding 4)Sever drug allergy 5)Sever renal and/or liver disfunction 6)Significant interstitial pneumonia or plumonary fibrosis by chest X-P 7)Pleural effusion, peritoneal effusion 8)Uncontrolled hypertension or diabetes mellitus 9)Maintenance therapy with systemic corticosteroids 10)Pregnant women or women with suspected pregnancy 11)Active double cancer 12)Severe psychiatric disorder 13)Active brain metastases 14)Participating in other chemotherapy or study 15) Judeged by the investigator to be unfit for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure Dose intensity(mg/m2/week) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate Progression free survival Clinical benefit rate Safety(AE) Dose | — |
Countries
Japan
Contacts
Public ContactKazutaka Narui
Yokohama City University Medical Center Breast and thyroid surgery
Outcome results
None listed