ERBB2 and breast carcinoma: The global lapatinib expanded access programme (LEAP) study was a single-arm open-label clinical trial that allowed access to lapatinib in combination with capecitabine for patients with HER2 overexpressing breast cancers, who had previously received anthracycline, taxane and trastuzumab, with the aim of providing clinical benefit while awaiting regulatory approval in individual countries, and further validating safety data observed in EGF100151 in a larger population (Ryan et al, 2008).