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

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