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

Inclusion Criteria:

Female or male patients ≥ 18 years old with WHO performance status ≤ 1
HER-2 over-expressing 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 (phase l)
Patient resistance to trastuzumab and taxanes (Phase ll)
Measurable disease according to RECIST (Phase ll)
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 mTOR inhibitors

Other protocol-defined inclusion/exclusion criteria may apply