BACKGROUND: lapatinib (TyverbÒ) is an oral small molecule inhibitor of ErbB1 and ErbB2. Lapatinib in combination with capecitabine has been approved for the treatment of patients with HER2+ advanced or metastatic breast cancer (MBC). Since January 2007 prior to its European registration, lapatinib was made available to patients through the (ATU). The full oral course of lapatinib + capecitabine does not require any hospital infusion. This may have a positive impact on care consumption OBJECTIVES: To describe clinical outcomes and health care resource utilisation of patients receiving lapatinib in the scope of the ATU, an everyday practice setting METHODS: Observational, retrospective study in patients who entered the ATU between January 1, 2007 and September 30, 2007. Data were collected from patients’ medical files between February 21, 2008 and April 30, 2008. RESULTS: A total of 198 patients were included (mean age = 55yrs). Most patients had already received 4 prior metastatic regimens. At this time, patients presented liver (53%), bone (52%) and brain (40%) metastases. 49% of patients responded positively to the treatment. The study showed a median TTP of 23 weeks. A median OS of 41.6 weeks was estimated with Kaplan-Meier survival analysis. While receiving lapatinib, 53% of patients had no hospitalization and 19% had only day admissions. In 70% hospitalizations were associated with disease progression while day admissions were associated with treatment follow-up (74%). Only 11% of hospitalizations and 2% of day admissions were associated with toxicity. Sixty-eight of patients had a consultation (inside or outside hospital) CONCLUSIONS: this study provides the first data on health care resource utilisation with lapatinib use in the French current medical practice. Clinical outcomes are consistent with trial results for advanced treatment lines. The study shows a limited care consumption driven by a very low rate of hospitalization