MAP Treatment Plan With Afinitor for Postmenopausal Women With Advanced HR+ Breast Cancer

Exclusion Criteria

• •Patients eligible for this Treatment Plan must not meet any of the following criteria:
• •History of hypersensitivity to any drugs or metabolites of similar chemical classes as the product.
• •1. Patient has HER2- overexpression confirmed by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
• •2. Patient requires chemotherapy for symptomatic visceral disease.
• •3. Patient is currently receiving hormone replacement therapy.
• •4. Patient has had prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus).
• •5. Patient has a known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus).
• •6. Patient is receiving treatment with systemic corticosteroids or other immunosuppressive agents.
• •7. Patient with a known history of HIV seropositivity.
• •8. Patient has uncontrolled diabetes as defined by fasting serum glucose \>1.5× ULN despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout participation in the program and adjusted as necessary.
• •9. Patient has any severe and/or uncontrolled medical conditions such as:
• •* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to randomization, serious uncontrolled cardiac arrhythmia,
• •* Active or uncontrolled severe infection,
• •* Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),
• •* Known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air),
• •* Active, bleeding diathesis.
• •10. Patient is unwilling to or unable to comply with the treatment plan.