Evaluation of lapatinib (Lap) plus capecitabine (Cap) in patients with brain metastases (BM) from HER2+ breast cancer (BC) enrolled in the Lapatinib Expanded Access Program (LEAP) and French Authorisation Temporaire d'Utilisation (ATU)

1094 Background: Lap has single agent activity against BM in patients (pts) with HER2+ (ErbB2+) BC. Lap + Cap increases response rate, time to progression, and progression-free survival when compared with Cap alone in pts with refractory HER2+ BC. An exploratory analysis of the latter study (EGF100151) showed fewer pts on Lap + Cap developed BM at first relapse compared with Cap alone. The LEAP and ATU were designed to provide access to Lap before commercial availability and were initiated after EGF100151 enrollment was halted. Eligibility requirements for these programs were similar to EGF100151, i.e., pts had disease progression following prior taxane, anthracycline, and trastuzumab therapy. Although data were not formally collected via case report forms, we surveyed LEAP and ATU sites to ascertain the percent of pts with progressive BM at entry and response to Lap + Cap. Methods: LEAP/ATU sites that enrolled 15 or more pts were queried to provide data via worksheets or narratives regarding progressive ...