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