Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy

Exclusion Criteria

• •1. Any local, or regional recurrence or metastatic disease
• •2. Any clinical or radiological suspicion of malignant or pre-malignant disease in the contralateral breast
• •3. Patients with pN1mi as sole nodal involvement
• •4. Previous cancer (excepted basal cell carcinoma of the skin or in situ carcinoma of the cervix) in the preceding 5 years, including invasive contralateral breast cancer
• •5. Patient already included in another ongoing therapeutic trial involving an unlicensed drug for which follow-up is required
• •6. Patient who is pregnant or breast-feeding. Adequate birth control measures should be taken during the study treatment phase
• •7. Patient with significantly impaired lung function (e.g. Chronic Obstructive Pulmonary Disease, respiratory insufficiency, Interstitial Lung Disease)
• •8. Positive serology for HIV infection or hepatitis C
• •9. Chronic carrier of HBV (positive Antigen HbsAg positive in the blood)
• •10. Patient with chronic infection
• •11. Uncontrolled diabetes defined as glycated haemoglobin , HbA1c \>7%
• •12. Uncontrolled hypercholesterolemia (cholesterol \>300 mg/dl under adequate therapy)
• •13. Known hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients
• •14. Patient with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study (e.g. patient who regularly require systemic steroids to control co-morbid disease)
• •15. Patient with any psychological, familial, social or geographical condition which could potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial