Advanced and recurrent breast cancer
Conditions
Interventions
Combination therapy of Eribulin and S-1
Sponsors
Advanced Clinical Research Organization
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.histlogically or cytologically confirmed breast cancer 2.patients with unresectable stage 3C or 4 3.patients with history of prior treatment with anthracycline and taxane as pre/post-operative treatment or treatment to prevent recurrence. 4.HER2 negative 5.patients previously treated with no more than 2 chemotherapy regimen for recurrent/metastasis breast cancer 6.patients with more than one of the following (1)ER negative (<10%) (2)internal metastasis (3)more than 3 metastatic sites (4)DFI<= 2years 7.patients at least 20 years of age but not older than 75 at the time of informed 8.ECOG performance status 0-1 9.patients with evaluable lesion(identified within 28 days before the entry) by RECIST 1.1 criteria 10.Required baseline laboratory parameters (within 14 days before the entry) neutrophil >=1,500/mm3 Plt >=100,000/mm3 Hb >=9.0g/dL AST and ALT <=100IU/L, (AST and ALT<=150IU/L, if patients have liver metastasis) total bilirubin <=1.5mg/dL creatinine clearance <=60 ml/min 11.no carry-over effect or side effect that could affect the study outcome of prior treatment washout period; 1) >=4weeks: antibody-drug, chemotherapy,operative treatment 2) >=2weeks:radiotherapy, endocrine therapy, immunotherapy, oral fluoride pyrimidine-based drug, molecular target drug, blood transfusion, blood products, G-CSF 12.written informed consent was obtained 13.with life expectancy greater than 3 months.
Exclusion criteria
Exclusion criteria: 1.patients with history of prior treatment with eribulin and S1 2.patients with infection or HBs antigen positive 3.pleural effusion, peritoneal effusion which needs drainage 4.brain metastasis with clinical symptoms 5.patients with following serious complication (1)ischemic heart disease and arrhythmic cardiac disease with poor control. (2)ischemic heart disease within 6 months, (3)liver cirrhosis, (4)watery diarrhea (5)interstitial pneumonia or pulmonary fibrosis by chest radiograph (6)bleeding tendency (7)another serious complication 6.patients with active double cancer 7.patients who need to receive continuous corticosteroid administration 8.patients with a history of widespread radiation therapy 9.pregnant or nursing women 10.patients with serious drug allergy 11.patients who are participating in the other clinical trial 12.patients judged improper to entry this trial by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Duration of response, Progression free survival, Disease control rate, Clinical benefit rate, Overall survival, New metastasis-free survival | — |
Countries
Japan
Contacts
Public ContactAdvanced Clinical Research Organization
Advanced Clinical Research Organization ERIS STUDY OFFICE
Outcome results
None listed