Managed Access Program to Provide Alpelisib for Patients With HR+ Advanced or Metastatic Breast Cancer

Exclusion Criteria

• •1. Patient has history of hypersensitivity to any drugs or metabolites of PI3K inhibitor.
• •2. Patient has not recovered to grade 1 or better (except alopecia) from side effects of any prior antineoplastic therapy
• •3. Patient has had major surgery within 14 days prior to starting treatment with alpelisib or has not recovered from major side effects
• •4. Patient is currently receiving high doses of systemic corticosteroids ≤ 2 weeks prior to starting treatment with alpelisib, or has not fully recovered from side effects of such treatment. (Note: low dose corticosteroids are permitted: single doses, topical applications, inhaled sprays, eye applications or local injections, stable low dose, for patients with CNS tumors, for at least 2 weeks prior to start of alpelisib treatment.)
• •5. Patient with uncontrolled diabetes mellitus.
• •6. Patient is being treated at start of treatment with alpelisib with any of the following drugs:
• •Drugs known to be strong inhibitors or inducers of isoenzyme CYP3A4 including herbal medications (list of prohibited CYP3A4 inhibitors and inducers provided in Table 13-2 in Appendix) Note: The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment with alpelisib is initiated. Switching to a different medication prior to starting treatment with alpelisib is allowed.
• •7. Patient is currently receiving warfarin or other coumarin derived anti-coagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed. Patients receiving therapies listed in Table 13-2 would not be allowed.
• •8. Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the Treating Physician's judgment, contraindicate patient participation in the individual patient program (eg. active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.)
• •9. Patient has a known history of Steven Johnson's syndrome or toxic epidermal necrolysis
• •10. Patient with active HIV infection (testing not mandatory) infection
• •11. Patient has any of the following cardiac abnormalities:
• •1. symptomatic congestive heart failure
• •2. history of documented congestive heart failure (New York Heart Association functional classification III-IV), documented cardiomyopathy
• •3. Left Ventricular Ejection Fraction (LVEF) \<50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
• •4. myocardial infarction ≤ 6 months prior to enrolment
• •5. unstable angina pectoris
• •6. serious uncontrolled cardiac arrhythmia
• •7. symptomatic pericarditis
• •12. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of alpelisib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)