Statement: Patients with end-stage liver disease are excluded from the primary trial and the secondary 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.
Secondary_evidence: Inclusion Criteria:   Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.   Been treated for early breast cancer with standard of care duration of trastuzumab.   Could have been treated neoadjuvantly but have not reached pathologic complete response. Exclusion Criteria:   Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.   History of heart disease.   Corrected QT (QTc) interval >0.45 seconds   History of gastrointestinal disease with diarrhea as the major symptom.