Study Comparing Inavolisib Plus Fulvestrant with Alpelisib Plus Fulvestrant for Advanced Breast Cancer with Specific Mutations

Inclusion Criteria

• If you are a premenopausal woman or a man, you must start hormone therapy at least 2 weeks before the study begins.
• You must have a confirmed diagnosis of advanced breast cancer that cannot be treated with surgery or radiation.
• Your cancer must be hormone receptor-positive and HER2-negative, as per specific guidelines.
• Your cancer must have a specific PIK3CA mutation, confirmed by a test.
• Your cancer must have progressed after or during treatment with CDK4/6 inhibitors and hormone therapy, with no more than two previous treatments for advanced cancer.
• You must have measurable or evaluable cancer according to specific criteria.
• You should be suitable for hormone-based therapy and not need chemotherapy at the start of the study.
• You must have a performance status score of 0, 1, or 2, indicating your ability to carry out daily activities.
• You should have a life expectancy of more than 6 months.
• You must have adequate blood and organ function before starting the study treatment.

Exclusion Criteria

• You have a type of breast cancer called metaplastic breast cancer.
• You have previously been treated with drugs that target the PI3K/AKT/mTOR pathway in advanced cancer.
• Your cancer returned more than 12 months after completing CDK4/6 inhibitor therapy without treatment for advanced cancer.
• You are pregnant, breastfeeding, or planning to become pregnant during the study or within 60 days after the last dose.
• You have Type 2 diabetes requiring ongoing treatment or a history of Type 1 diabetes.
• You cannot or do not want to swallow pills.
• You have a condition that affects how your body absorbs medication.
• You have a history of cancer spreading to the brain or spinal cord.
• You have untreated or active cancer in the central nervous system.
• You have an active infection or a major infection requiring treatment within 7 days before starting the study.
• You have an eye condition that may need treatment during the study.
• You need daily supplemental oxygen.
• You have active lung disease or inflammation.
• You have inflammatory bowel disease or active bowel inflammation.
• You have significant liver disease or current alcohol abuse.
• You have HIV and do not meet specific criteria.
• You have taken an investigational drug recently.
• You have had another cancer within the last 5 years, except for those with a low risk of recurrence.
• You are on chronic therapy with high doses of corticosteroids or immunosuppressants.
• You have allergies to the study drugs.
• You have a history of severe skin reactions.
• You have ongoing osteonecrosis of the jaw.