APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)

Inclusion Criteria: * Females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (HER2/neu+) breast cancer * Have progressed after treatment with chemotherapy including a taxane and trastuzumab * Must have measurable disease by RECIST * ECOG PS of 0,1, or 2 * MUGA scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50% Exclusion Criteria: * Radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment * Evidence of New York Heart Association class III or greater cardiac disease * History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality * History of congenital QT prolongation * Concurrent severe or uncontrolled medical disease * Symptomatic central nervous system metastases * Pregnant or nursing women * Hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-FU, sulfonamides, aspirin, or NSAIDs * Severe renal insufficiency * History of upper GI bleeding, ulceration, or perforation- Concurrent use of potent CYP3A4 inhibitors and CYP3A4 inducers * Prior treatment with capecitabine * Patients on anti-arrhythmic treatment * Prior lapatinib therapy