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