breast cancer
Conditions
Interventions
administration of eribulin 1.4mg/m2 on day1 and day8 every 3 weeks
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed breast cancer. 2)ECOG performance status 0-2 3)Measurable disease 4)Three or less regimens of chemotherapy for breast cancer and one or less regimen of chemotherapy for locally advanced or metastatic breast cancer 5)No history of eribulin treatment 6) Meet the cirteria of baseline labolatory parameters as below. Netrophils count 1500/mm3 or more, Plt 100,000/mm3 or more, Hb 9g/dl or more, T.Bil 2mg/dl or less, GOT and GPT within 2.5ULN, CRN 1.5mg/dL or less, 7)Expected to have more than 3 months of survival 8)Normal ECG 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients with infection or fever 2)History of severe allergy 3)History of renal or liver failure 4)Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X ray 5)Patients with pleural effusion of ascites that needs to be treated 6)Patients with hypertention or diabetes that are not controlled by medication 7)Administration of systemic steroids 8)Pregnancy 9)Patients who had transfusion or injection of G-CSF within 7 days before the treatment 10)Other active malignancies 11)Clinically significant mental disorder 12)CNS involvement 13)Participants of other treatment protocol 14)Other medical conditions that could limit a patient's ability to undertake study therapy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, overall survival, safety | — |
Primary
| Measure | Time frame |
|---|---|
| objective response rate | — |
Countries
Japan
Contacts
Public ContactChisato Saito
Keio University School of Medicine Department of surgery
Outcome results
None listed