Clinical trial NCT00496379 (phase 2, status: terminated)
Conditions: breast cancer, cns disease
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: zk219477
SMILES: C[C@H]1CCC[C@@]2(C)O[C@H]2C[C@H](OC(=O)C[C@H](O)C(C)(C)C(=O)[C@H](CC=C)[C@H]1O)C1=CC=C2SC(C)=NC2=C1
Reason stopped: 
    this study has closed to accrual early due to slow accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically invasive breast cancer, with
             metastatic disease at the time of screening

          -  Measurable Central Nervous System (CNS) disease, as defined as at least one lesion >
             or equal too 10mm in longest dimension

          -  New or progressive CNS lesions after at least one prior standard CNS-directed therapy
             for treatment of brain metastases, which could include surgical resection, whole brain
             radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have
             received prior WBRT, SRS or both.

          -  Patient has been evaluated by a radiation oncologist, who feels that the plan to
             evaluate systemic chemotherapy in place of additional brain radiotherapy is an
             acceptable option

          -  No increase in corticosteroid use in the week prior to study entry

          -  Any number prior lines of chemotherapy for metastatic breast cancer

          -  18 years of age of older

          -  Life expectancy of greater than 12 weeks

          -  ECOG Performance Status 0-2

          -  Patients must have normal organ function as outlined in the protocol

        Exclusion Criteria:

          -  Patients who have had chemotherapy within 3 weeks prior to entering the study or those
             who have not recovered from adverse events due to agents administered more than 3
             weeks earlier

          -  Patients who have had XRT within 3 weeks prior to entering the study or those who have
             not recovered from adverse events due to XRT

          -  Patients may not be receiving any other investigational agent

          -  Patients may not be receiving any cancer-directed therapy

          -  Prior treatment with investigational chemotherapy for brain metastases

          -  Prior treatment with epothilone for metastatic breast cancer

          -  Leptomeningeal carcinomatosis as the only site of CNS involvement.

          -  Concurrent treatment with an enzyme inducing antiepileptic drug, including phenytoin,
             carbamezepine, phenobarbital, or oxacarbazepine

          -  More than 2 seizures over the last four weeks prior to study entry

          -  Known contraindication to MRI or gadolinium contrast, such as cardiac pacemaker,
             ocular foreign body, or shrapnel

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant or breastfeeding women.