metastatic breast cancer
Conditions
Interventions
Eribulin (1.4 mg/m2) is administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. Dose reductions and dose delays are allowed according to eribulin'
s prescribing information or physician'
s choice.
Sponsors
Fujita Health University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed breast cancer 2)ECOG performance status(PS)0~2 3)Discontinuation of previous treatment chemotherapy: 4 weeks (If previous chemotherapy is not effective, 2 weeks is possible for inclusion) radiation: 2 weeks 4)Measurable disease 5)No history of eribulin treatment 6)Adequate organ function Meet the criteria of baseline laboratory parameters as bellows. WBC:3,000/mm3 or more, or neutrophils:1,500/mm3 or more platelets:100,000mm3 or more Hb:9.0g/dL or more Total bilirubin:2.0 mg/dL or less AST (GOT), ALT (GPT):within 2.5 ULN in patients with liver metastasis, within 5 ULN creatinine:1.5 mg/dL or less 7)Expected to have more than 3 months of survival 8)without medical problem in ECG 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients with infection or patients with fever and suspected infection 2)Patient with watery diarrhea, bowel paralysis or ileus 3)Patients with fresh bleeding from gastrointestinal tract 4)History of severe drug allergy 5)Patients with severe renal dysfunction or liver dysfunction 6)Patients with interstitial pneumonia or pulmonary fibrosis revealed on chest X-rays 7)Patients with massive pleural effusion or ascites that need to be drained 8)Patients with poorly controlled hypertension or diabetes 9)Patients administrated continuously steroids for long term 10)Pregnant 11)Other active malignancies excluding carcinoma in situ cured by local treatment 12)History of severe mental disorder or central nervous system disorder 13)Patients who are judged to be inappropriate as an object for this treatment by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline to day 15+-4 in expression of EMT related markers and vitamin D receptor in tumor tissue | — |
Countries
Japan
Contacts
Public ContactToshiaki Utsumi
Fujita Health University Department of breast surgery
Outcome results
None listed