Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
Condition: Metastatic Breast Cancer; Brain Metastases
MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms
Intervention: Eribulin Mesylate; MRI; Pre-Medication: Zofran; Pre-Medication: Decadron
Intervention description: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.; An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate; Zofran at 8mg orally. Given at the discretion of the treating physician; decadron at 8mg orally. Given at the discretion of the treating physician
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: eribulin; central nervous system; CNS; Eribulin Mesylate; Halaven

Summary:

      Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug.
      Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by
      the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is
      FDA approved for use in patients with metastatic breast cancer but the effect it may or may
      not have on brain metastases has not been studied.
    

Eligibility criteria:

        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 MRI.

          -  Brain metastases from breast cancer with or without prior WBRT, STS of surgical
             resection. 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

          -  No chemotherapy for > 3 weeks before planned start of protocol treatment

          -  Adequate bone marrow, renal, and hepatic function, per local reference laboratory
             ranges as follows:

               -  Absolute neutrophil count (ANC) ≥ 1,500/mm3

               -  Platelet count ≥ 100,000/mm3

               -  Hemoglobin ≥ 9 g/dL

               -  Calculated creatinine clearance (CrCl) ≥ 30mL/min (Cockcroft-Gault method)

               -  Patients with normal, mild or moderate hepatic dysfunction are eligible.

               -  Calcium <10.1 mg/dL (corrected to serum albumin as follows: Corrected Calcium =
                  (0.8 x (4 - patient albumin)) + serum Ca

          -  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 and without 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 QTc prolongation >450ms.

          -  Patients with grade 3/4 peripheral neuropathy.

          -  Patients with pacemaker or an ICD devices.

          -  Previous treatment with eribulin mesylate.