Eribulin Mesylate in Treating Patients with Brain Metastases from Breast Cancer

Inclusion Criteria

• Female with histologically confirmed breast cancer
• Patients must have evidence of metastatic disease (non measurable disease is eligible)
• Radiologically confirmed metastatic brain lesion by magnetic resonance imaging (MRI)
• Brain metastases from breast cancer with or without prior treatment; whole brain radiotherapy (WBRT), stereotactic radiosurgery (SRS) or surgical resection permitted through progression; progression must be documented in an at least one lesion untreated by SRS or in any site after surgery or WBRT
• Patients must be neurologically stable and with stable dose steroids and anticonvulsants for at least 1 week prior to obtaining the baseline MRI of the brain, and/or at least 1 week prior to beginning study treatment
• No presence of uncontrolled systemic disease or tumor related complication which, in opinion of the investigator, might restrict life expectancy to less than 3 months
• Patients may not be on any cytotoxic chemotherapy or hormonal treatment for breast cancer during protocol treatment; (trastuzumab is allowed in HER2 positive patients)
• Able to comprehend and willing to sign an Informed Consent Form (ICF)
• Karnofsky performance status >= 60
• No brain radiation therapy > 4 weeks before planned start of protocol treatment
• No chemotherapy for > 3 weeks before planned start of protocol treatment
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin >= 9 g/dL
• Calculated creatinine clearance (CrCl) >= 30 mL/min (Cockcroft-Gault method)
• Patients with normal, mild or moderate hepatic dysfunction are eligible
• Calcium < 10.1 mg/dL (corrected to serum albumin)
• Females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment
• Able to undergo MRI evaluation with gadolinium contrast

Exclusion Criteria

• Patients with the presence of an active infection, abscess or fistula
• Known leptomeningeal disease or CNS midline shifts
• Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease
• Severe conduction abnormality including significant corrected QT (QTc) prolongation > 450 ms
• Patients with grade 3/4 peripheral neuropathy
• Patients with pacemaker or an implantable cardioverter defibrillator (ICD) devices
• Previous treatment with eribulin mesylate