Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer

Exclusion Criteria

• •1. Previous treatment with Vinorelbine or an inhibitor of mTOR
• •2. Treatment with other study medication within 28 days before start of treatment
• •3. Patients who have received prior radiotherapy to ≥ 25% of the bone marrow
• •4. Other tumours in the previous 5 years with exception of an adequately treated basal cell carcinoma of the skin or a preinvasive cervix carcinoma
• •5. Simultaneous use of known CYP3A4 inducers (e.g. Phenytoin, Rifampicin) or inhibitors of this enzyme (e.g. Itraconazole, Ketoconazole), therefore also use of mistletoe, St John's wort or grapefruit juice
• •6. Patients to whom at least one of the conditions applies:
• •* Substance abuse
• •* medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
• •* Legal incapacity or limited legal capacity
• •* Subjects who are unable to take oral medication
• •* Any condition that could jeopardise the safety of the patient and their compliance in the study as judged by the investigator
• •7. History of cardiac dysfunction including one of the following:
• •* Myocardial infarction by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function
• •* History of documented congestive heart failure (NYHA ≥ 3)
• •* Documented cardiomyopathy
• •8. Known HIV infection or chronic hepatitis B or C or history of hepatitis B / C
• •9. Active clinically relevant infection (\> grade 2 NCI-CTC Version 4.03)
• •10. Clinical or radiological detection of CNS metastases
• •11. Patients receiving concomitant immunosuppressive agents or chronic use of corticosteroids at the time of study entry except in cases outlined below:
• •* topical applications (e.g. rash,) inhaled sprays, (e.g. obstructive airway diseases) eye drops or local injections (e.g. intraarticular) are allowed
• •12. Active bleeding diathesis or an oral anti-vitamin K medication (except low-dose warfarin and aspirin or equivalent, as long as the INR ≤ 2)
• •13. Kidney function disorder requiring dialysis
• •14. Seriously impaired liver function (Child-Pugh, class C)
• •15. Known hypersensitivity reaction to Vinorelbine or Everolimus
• •16. Pregnant or breast-feeding subjects