Statement: Patients with end-stage liver disease are excluded from the primary trial.
Primary_evidence: Inclusion Criteria:   Histological confirmation of invasive carcinoma of the breast.   HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ hybridization (FISH) (+).   Stage IV breast cancer with measurable disease.   Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin alone. No more than two Herceptin containing regimens.   Zubrod performance status 0 or 1.   Adequate hematological parameters (White Blood cells-WBC > 3,000/mm3, platelet count > 100,000/mm3), adequate renal function (serum creatinine < 2.0 mg/dl), adequate liver function (total bilirubin, aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) < 3 x normal). Exclusion Criteria:   Active Brain metastasis.   No measurable disease at the time of registration (e.g. bone only, leptomeningeal disease alone or pleural effusion alone).   More than 2 Herceptin containing regimens in metastatic breast cancer.   Known history of HIV positive.   Chronic active hepatitis or cirrhosis.   Symptomatic pulmonary disease.   Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week prior to registration.