OBJECTIVES: To assess the burden of illness associated with advanced breast cancer treated with vinorelbine oral (VinO) or IV (VinIV) from the perspective of patients and caregivers in 5 European countries. METHODS: This was an observational, prospective, international, multicentric study. Patients were included in the study at the beginning of their 2nd cycle of chemotherapy with vinorelbine and categorized in 2 groups depending on whether they are receiving VinO or VinIV. At baseline (V0) and at the end of the 2nd cycle of chemotherapy (V1), patients and caregivers were asked to complete self-administered questionnaires: SF-12, EORTC-QLQ-C30 (only for patients) and burden of illness. RESULTS: At  baseline, there were no major differences in demographic and clinical characteristics between the two groups. VinIV was prescribed monotherapy in 56.9% and 62.5% for VinO.  Patients receiving VinO were predominantly treated with monotherapy. In addition, as measured with SF-12, patients with VinO (n=128) had, at end of cycle 1 and end of cycle 2, significantly more favourable outcomes in physical summary score, role physical, role emotional and mental health (all p<0.05) than those treated with VinIV (n=51). Trends for a better caregiver mental score and social functioning were also observed with VinO (cycle 1 and 2; p<0.10). From a patient perspective, no major difference was reported on the burden of illness between the two groups, however, a trend for a better ”overall impact on daily life” was observed in VinO patients. Major significant differences, showing a lower burden of illness with VinO, were also reported from caregivers (Social functioning, Overall impact on daily life). CONCLUSIONS: Oral vinorelbine showed some benefits over the IV form for both patients and caregivers, particularly in health related QoL and burden of illness.