Study on Inavolisib and Phesgo for Treating Advanced HER2-Positive Breast Cancer with PIK3CA Mutation

Inclusion Criteria

• Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a confirmed diagnosis of breast cancer that is either metastatic (spread to other parts of the body) or locally advanced and cannot be removed by surgery.
• Have HER2-positive cancer confirmed by specific tests.
• Have a PIK3CA mutation in the tumor confirmed by specific tests.
• Have been free of cancer for at least 6 months after completing previous non-hormonal cancer treatments.
• Have a heart function of at least 50% as measured by specific heart tests.
• Have adequate blood and organ function before starting the study treatment.

Exclusion Criteria

• Have previously been treated with drugs that target the PI3K-AKT-mTOR pathway for advanced breast cancer.
• Have received any non-hormonal cancer treatment for advanced HER2-positive breast cancer before starting the study treatment.
• Have a history of inflammatory bowel disease.
• Have cancer that progressed within 6 months of receiving any HER2-targeted therapy.
• Have Type 2 diabetes requiring ongoing treatment or a history of Type 1 diabetes.
• Have an active hepatitis B infection.
• Have significant liver disease, including severe liver problems, hepatitis, alcohol abuse, or cirrhosis.
• Have active lung disease, such as pneumonitis or interstitial lung disease.
• Have a history of cancer spread to the brain or spinal cord lining.
• Have had a serious infection requiring IV antibiotics within 7 days before starting the study.
• Have any eye condition that might need medical or surgical treatment during the study to prevent vision loss.
• Have active inflammatory or infectious conditions in the eyes or a history of certain types of eye inflammation.