A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer

Inclusion Criteria:

- Adult Women (≥ 18 years old).

- Histologically or cytologically confirmed invasive breast carcinoma with local
recurrence or radiological evidence of metastatic disease.

- Must have at least one lesion that can be accurately measured or bone lesions in the
absence of measurable disease.

- HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization
positive).

- Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant
treatment is allowed but should be discontinued > 12 months prior to randomization.

- Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic
settings) is allowed but should be discontinued at randomization. Patients treated
with bisphosphonates at entry or who start bisphosphonates during study may continue
this therapy during protocol treatment.

- Documentation of negative pregnancy test.

Exclusion Criteria:

- Prior mTOR inhibitors for the treatment of cancer.

- Other anticancer therapy for locally advanced or metastatic breast cancer except for
prior hormonal therapy.

- Patients with only non-measurable lesions other than bone metastasis (e.g. pleural
effusion, ascites, etc).

- Radiotherapy to ≥ 25% of the bone marrow within 4 weeks prior to randomization

- History of central nervous system metastasis.

- Impairment of gastrointestinal (GI) function or GI disease or active ulceration of
the upper gastrointestinal tract.

- Serious peripheral neuropathy.

- Cardiac disease or dysfunction.

- Uncontrolled hypertension.

- HIV.

- Pregnant, Other protocol-defined inclusion/exclusion criteria may apply