breast cancer
Conditions
Interventions
eriburin 1.4mg/m2 day1,8 iv every 3 weeks.1.4mg/m2 biweekly iv is performed when not meeting the entry criteria by 2nd cycle Day1.
Sponsors
NPO Advanced Clinical Reserch Organization
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) advanced or recurrent breast cancer (2) previous treatment with anthracyclines and taxanes (3) aged 20 and over (4) HER2-negative breast cancer (5) ECOG performance status 0-2 (6) having measurable lesion according to RECIST version 1.1 (7) suffient organ function(e.g. marrow,liver, kidney,bone) (8) expected survival time more than 3 months (9) written informed consent
Exclusion criteria
Exclusion criteria: (1) infectious disease with fever (2) heart failure with clinically problem. significant interstitial pneumonia or pulmonary fibrosis by chest radiograph (3) pleural effusion, peritoneal effusion (4) presence of the active other malignancies (5) poorly controlled diabetes mellitus(6) brain metastasis with symptom (7) pregnant or nursing women (8) physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical benefit rate of biweekly iv | — |
Secondary
| Measure | Time frame |
|---|---|
| safety of biweekly iv time to treatment failure of biweekly iv overall survival of biweekly iv clinical benefit rate of 1.4mg/m2 day1,8 iv every 3 weeks safety of 1.4mg/m2 day1,8 iv every 3 weeks time to treatment failure of 1.4mg/m2 day1,8 iv every 3 weeks overall survival of 1.4mg/m2 day1,8 iv every 3 weeks | — |
Countries
Japan
Outcome results
None listed