Study on the Safety of Inavolisib and Fulvestrant, With or Without Palbociclib, for Advanced Breast Cancer and Type 2 Diabetes

Inclusion Criteria

• Have type 2 diabetes with stable blood sugar levels, not requiring insulin.
• Eligible to receive the combination of inavolisib, fulvestrant, and palbociclib, with no prior treatment for advanced breast cancer.
• Have a confirmed diagnosis of HR+/HER2- breast cancer.
• Have a specific genetic mutation in the PIK3CA gene.
• Have measurable cancer according to standard criteria.
• Be in good overall health with an ECOG performance status of 0 or 1.
• Have adequate blood and organ function as determined by tests within 14 days before starting the study treatment.

Exclusion Criteria

• Pregnant or breastfeeding, or planning to become pregnant during the study.
• Have a type of breast cancer called metaplastic breast cancer.
• Have a history of type 1 diabetes.
• Have had severe blood sugar problems in the last 6 months.
• Have a history of cancer spreading to the brain or spinal cord.
• Have untreated or active cancer in the central nervous system, unless previously treated.
• Have active eye inflammation or a history of certain eye conditions.
• Have active lung disease causing symptoms.
• Have a history of active bowel inflammation or inflammatory bowel disease.