Advanced or metastatic breast cancer
Conditions
Interventions
Eribulin
Sponsors
Dept. Surgical Oncology, Osaka City University Graduate School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)patient who confirmed histologically HER2 negative as metastatic breast cancer 2)ferst-line chemotherapy 3)ECOG PS 0-1 4)having measureable lesion according to RECIST 5)adequate organ functions confermed with following major examination neutrophil=>1500mm3 platelet count=>100,000/mm3 hemoglobin=>9.0g/dL AST,ALT=<75IU/L total bilirubin=<1.5mg/dL serum creatinine=<1.5mg/dL 6)Expected survival time : more than 3 months 7)obtained written informed consent
Exclusion criteria
Exclusion criteria: 1)having systemic infection 2)pleural effusion,ascites,hydropericardium that is not good control 3)symptomatic brain metastasis 4)patient with following serious complication heart disease that is not good control myocardial infarction in the latest 6th months cirrhosis interstitial pneumonia,pulmonary fibrosis bleeding tendency 5)having active multiple cancers 6)menopausal women patients having possibility pregnancy 7)systemic steroid therapy 8)widespread radiation therapy 9)patient who reject supportive therapy for myelosuppresion 10)judged by the investigator to be unfit to be enrolled into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Countries
Japan
Contacts
Public ContactTsutomu Takashima
Osaka Breast Cancer Chemo-Endocrine Therapy Study Group Executive office
Outcome results
None listed