Breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with pathologically confirmed metastatic/reccurent breast cancer. 2) HER2 positive. 3) Age >=20 and 80=< 4) Performance status (PS, ECOG scale): 0-2. 5) History of one or more cytotoxic agent and anti-HER2 therapy. 6) Adequate organ functions, measured as follows: Neutrophils: >= 1,500/mm3 Platelet: >= 100,000/mm3 Total birilbin: <= 1.5 x ULN AST (GOT): <= 3.0 x ULN ALT (GPT): <= 3.0 x ULN Serum creatinine: <= 1.5 x ULN 7) LVEF: >= 50% 8) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Past history of severe hypersensitivity. 2) History of eribulin use during 6 months prior to consent. 3) Active multiple primary malignancy. 4) Patients with uncontrolled infection. 5) Patient with disease requiring emergent intervention. 6) Patients with progressive brain metastasis requiring treatment during 6 months prior to consent. 7) Patients with severe complications. 8) Pregnant or breastfeeding. 9) Patients who deny contraception during this study. 10) Any other cases that the attending doctor judges not appropriate to enroll to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan
Contacts
Mie University Hospital Dep. of Hematology and Oncology