Statement: Men suffering from Ulcerative colitis are excluded from the primary trial, but eligible for the secondary trial.
Primary_evidence: 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.   Organ functions at time of inclusion. 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,
Secondary_evidence: Inclusion Criteria:   The subject must be female and 18 years of age or older.   The subject must be a preoperative clinical Tis, T1, T2, T3, T4, as well as clinical N0 and clinical M0 breast cancer   The subject must have a diagnosis of primary breast cancer.   The subject must be a candidate for surgical intervention, either with lumpectomy and SLNB or with mastectomy and SLNB, as the treatment of her breast cancer.   The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 - 2   The subject must provide written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study Exclusion Criteria:   The subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.   The subject has a known hypersensitivity to vital blue dye (VBD) in a case where vital blue dye was planned for use during SLNB.   The subject has a positive pregnancy test or is lactating.   The subject has had prior surgery to the indicated breast or axilla.