Access Program for Alpelisib in Patients with Advanced Breast Cancer

Inclusion Criteria

• Must be 18 years or older with advanced hormone receptor-positive, HER2-negative breast cancer.
• Must have a mutation in the PIK3CA gene, confirmed by a lab test.
• If female, must be postmenopausal, which can be due to age, surgery, or natural menopause.
• Cancer must have progressed during or after treatment with aromatase inhibitors like letrozole or anastrozole.
• Must have a confirmed diagnosis of ER+ and/or PgR+ breast cancer.
• Must have adequate blood sugar levels and organ function as shown by specific lab tests.

Exclusion Criteria

• Cannot have had previous treatment with PI3K, mTOR, or AKT inhibitors.
• Cannot have allergies to Alpelisib or its ingredients.
• Cannot have had major surgery within 14 days before starting treatment.
• Cannot have uncontrolled diabetes or certain gastrointestinal issues.
• Cannot have lung disease or certain heart conditions.
• Cannot have uncontrolled high blood pressure or severe heart disease.
• Cannot be pregnant or breastfeeding.
• Must not have other severe medical conditions that would interfere with treatment.
• Must not be taking certain medications that interact with Alpelisib.
• Must not have had recent pancreatitis or unresolved jaw issues.
• Must not have had recent severe skin reactions.
• Must not have had recent radiotherapy or be on systemic corticosteroids.
• Must not have other cancers within the last 3 years, except for certain skin or cervical cancers.
• Must not have untreated brain metastases or be on certain medications for brain issues.
• Must be able to understand and follow treatment instructions.
• Women of childbearing potential must use effective contraception during and after treatment. Men must use condoms and not donate sperm during and after treatment.