Breast Cancer
Conditions
Interventions
vinorelbine 25mg/m2,IV, Day1,8 Gemcitabine 1200mg/m2,IV,Day1,8 Every21 days
Sponsors
Kinki Multidisciplinary Breast Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patient who confirmed histologically HER2 negative as Metastatic breast cancer 2)ECOG PS 0-1 3)Mesurable disease as per RECIST criteria 4)Patients who have been taxans refractory and don't have recieved vinorelbine and Gemcitabine 5)Adequate organ functions confirmed with following major examination conducted within 14 days before each patient's registration leukocyte>=3000mm3 or neutrophil>=1500mm3 hemoglobin>=9.0g/dL platelet count>=100,000/mm3 AST,ALT<=100IU/L total bilirubin=<1.5mg/dL serum creatinine<=1.5mg/dL 6)Expected survival time : more than 3 months 7)Clinically no problem with an electrocardiogram 8) Given written informed concent
Exclusion criteria
Exclusion criteria: 1) Pulmonary fibrosis or pneumonia 2) body cavity fluid whichi needs to be treated 3)Symptomatic brain metastasis 4) Active double cancer 5) The diabetes that is impossible of control and high blood pressure case 6)HBs antigen positive 7)Heart diseases with the following items History of myocardial infarction ,unstable angina,post status of PTCA or CABG occurred within past 6 months Congestive heart failure Arrhythmia which needed to be treated 8)Apparently/possibly during pregnancy or lactation expectant 9) Serious drug allergy 10) Judged by the investigator to be unfit to be enrolled into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Overall survival, Time to treatment failure, Safety profiles | — |
Countries
Japan
Contacts
Public ContactNorikazu Masuda
Kinki Multidisciplinary Breast Oncology Group Executive office
Outcome results
None listed