HER2-negative metastatic breast cancer
Conditions
Interventions
Patients were included in the run-in phase (three cycles of Bevacizumab plus paclitaxel). After induction chemotherapy, patients who did not have progressive disease receive Eriburin
Sponsors
Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)female patients who were histologically or pathologically confirmed as breast cance 2)The patient who fills following either about diagnosis of transition and recurrent breast cancer -I have a distant metastases that do not surgery at the time of the first visit -After treatment (after surgery and the before and after treatment) is a breast cancer that has progressed or recurrence at distant metastasis. However, local recurrence (operated side of upward subclavian edge, downward costal arch, inside sternum midline, outside refers to the chest wall is surrounded by latissimus dorsi leading edge) is excluded. Even in local recurrence, to qualify if they are a surgery outside in diffuse lesions, etc. 3)aged more than 20years and less than 75 years 4)ECOG PS of 0-2 5)having measurable lesion according to RECIST 6)adequate organ functions confirmed with following major examination: neutrophil count more than 1500/mcl platelet count more than 80,000/mcl hemoglobin more than 9.0g/dL AST,ALT less than 2.5 times the upper limit of nomal (ULN) AST,ALT of the patient with the metastasis to liver less than 5.0 times the upper limit of nomal (ULN) total bilirubin less than 1.5 times the upper limit of nomal (ULN) serum creatinine less than 1.5 times the upper llimit of nomal (ULN) 7)Persistent Grade <=1 sensory neuropathy at enrollment 8)HER2 negative disease 9)life expectancy of at least 3 months from enrolment 10)no problem in clinical at electrocardiogram 11)no prior therapy with eribulin, paclitael and bevacizumab 12)obtained written informed consent
Exclusion criteria
Exclusion criteria: 1)having systemic infection with a fever of 38 degrees or more 2)protocol treatment of drug, and a history of hypersensitivity to the solvent 3)patients with brain metastases in need of treatment to the brain hypertension and emergency brain radiation 4)patients with following serious complication ischaemic heart disease or heart disease such as arrhythmia not controllable by treatment myocardial infarction < 6 months prior to study entry hepatic cirrhosis interstitial pneumonia or pulmonary fibrosis bleeding tendency Uncontrolable hypertension Uncontrolable proteinuria 5)having active double cancer 6)patients with a history of radiation therapy to the measurable lesions 7)history of mental disorder, a central nervous system damage, and cerebral blood vessel neuropathy 8)pregnancy, breast-feeding or women with childbearing potential 9)patients undergoing continuous systemic administration of steroids 10)HBs antigen is positive 11)judged by the investigator not to be appropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Treament Failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival/ Objective Response Rate/ Overall Survival/ Safety/ FACT-GOG-NTX | — |
Countries
Japan
Contacts
Public ContactKenichi Inoue
Saitama Cancer Center Division of Breast Oncology
Outcome results
None listed