Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

Inclusion criteria: * Female or male patients ≥18 years with WHO performance status ≤ 1 * HER-2 overexpressing metastatic breast cancer cells confirmed by histology * Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy * Patients neurologically stable with adequate bone marrow, liver and renal function Exclusion criteria: * Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start * Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start * Patients who have previously received vinorelbine or mTOR inhibitors Other protocol-defined inclusion/exclusion criteria may apply