An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory

Inclusion Criteria

• •Patient's oncologist must have documented experience in a prior eribulin clinical trial
• •Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy
• •Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:
• •1. Anthracyclines, taxanes, and capecitabine
• •2. Ixabepilone, in countries where this agent is marketed
• •3. Trastuzumab, for Her-2 positive disease
• •4. Hormonal therapy, in hormone receptor-positive disease
• •5. All other commercially available therapies, e.g. gemcitabine or vinorelbine, used for the treatment of advanced breast cancer (see NCCN guidelines)
• •ECOG performance status greater than or equal to 2
• •Adequate kidney function: serum creatinine less than or equal to 2.0 mg/dL or creatinine clearance greater than or equal to 40 mL/min
• •Adequate bone marrow function: absolute neutrophil count greater than or equal to 1.5 x 10\^9/L, hemoglobin greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10\^9/L
• •Adequate liver function: total bilirubin less than or equal to 1.5 x upper limit of normal (ULN), alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase less than or equal to 3 x ULN (or less than or equal to 5 x ULN in case of liver metastases). If alkaline phosphatase is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND patient also is known to have bone metastases, the liver specific alkaline phosphatase must be used to assess liver function instead of total alkaline phosphatase
• •Willing and able to comply with all aspects of the treatment protocol
• •Provision of written informed consent
• •Female, aged at least 18 years
• •Patients of childbearing potential must agree to be abstinent or to use a highly effective method of contraception