Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed invasive breast carcinoma with locally
recurrent or radiological evidence of metastatic disease. Locally recurrent disease
must not be amenable to resection with curative intent.

- HER2+ status defined as IHC 3+ staining or in situ hybridization positive

- Patients with resistance to trastuzumab

- Prior taxane therapy

- Patients with an ECOG performance status of 0 - 2

- Patients with measurable disease as per RECIST criteria

- Documentation of negative pregnancy test for patients of child bearing potential
prior to enrollment within 7 days prior to randomization. Sexually active
pre-menopausal women must use adequate contraceptive measures, excluding estrogen
containing contraceptives, while on study;

- Patients must meet laboratory criteria defined in the study within 21 days prior to
randomization

Exclusion Criteria:

- Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer

- More than three prior chemotherapy lines for advanced disease.

- Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated
asymptomatic CNS metastases are allowed provided that the last treatment for CNS
metastases was completed >8 weeks prior to randomization

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of oral everolimus

- Peripheral neuropathy ≥ grade 2 at randomization

- Active cardiac disease

- History of cardiac dysfunction

- Any malignancy within 5 years prior to randomization, with the exception of
adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell
carcinoma or non-melanomatous skin cancer

- Known hypersensitivity to any study medication

- Breastfeeding or pregnant

Other protocol-defined inclusion/exclusion criteria may ap