Breast cancer
Conditions
Interventions
eriburin 1.4mg/m2 day1,8 iv every 3 weeks, until progressive
Sponsors
Kyushu Breast Cancer Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.advanced or recurrent breast cancer 2.ECOG performance status 0-2 3.Her2 negative 4.aged from 20 years to 75 years 5.no treatment period prior to study chemotherapy- 4 weeks(two weeks of no treatment are acceptable if prior treatment is not considered to affect the study, e.g. antimetabolites) endocrinethrapy, radiation therapy- 2 weeks 6.having measurable lesion according to RECIST 7.previous treatment with anthracyclines and taxanes 8.previously untreated with eribulin 9.suffient organ function(e.g. bone marrow, cardiac, liver and kidney) 10.no significant abnormal EKG 11.written informed consent
Exclusion criteria
Exclusion criteria: 1 ineligible patients complicated with infectious diseases or who suspected infectious diseases with fever 2. diarrheal , ileus 3. GI bleeding 4.severe drug allergy 5. severe renal and/ or liver dysfunction 6.significant interstitial pneumonia or pulmonary fibrosis by chest radiograph 7.pleural effusion, peritoneal effusion 8.poorly controlled hypertension or diabetes mellitus 9.maintenance therapy with systemic corticosteroids 10.pregnant women or women with suspected pregnancy 11.patients who received blood transfusion, blood products or G-CSF within 7 days prior to this study 12.presence of the active other malignancies 13.severe psychiatric disorder 14 brain metastases 15.patients judged by the investigator to be unfit for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of response progression- free survival overall survival | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Kyushu Breast Cancer Study Group Exective office
Outcome results
None listed