To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer

To be able to join this study, you would generally need to have a solid tumour, including breast cancer, that has spread locally or to other parts of the body, and your cancer cells must have a specific genetic change called a PIK3CA mutation. Your general health should be good enough to take part, measured by your ability to carry out daily activities, and you should be expected to live for at least 12 weeks. Important blood tests, and checks on your liver and kidney function, must also be within healthy ranges. For some parts of the study, you'll need to have had previous treatment, for example, with a CDK4/6 inhibitor for certain breast cancers, or have specific heart health. This study is for both men and women aged 18 or over.

However, there are reasons why you might not be able to join. For instance, if you have a rare type of breast cancer called metaplastic breast cancer, or if your cancer has spread to the fluid around your brain or spinal cord. Other reasons include having uncontrolled diabetes that needs medication, difficulty swallowing pills, or problems absorbing food, as these could affect how the study drug works. You also wouldn't be able to join if you have uncontrolled infections, a history of certain heart problems, or if you've had another type of cancer within the last five years (excluding some very early-stage cancers like certain skin or cervical cancers).

Taking part in this study would involve regular visits to the clinic for assessments. These will likely include physical examinations, blood tests, and scans to check on your overall health and how your cancer is responding. You'll be given the study drug, Inavolisib, usually as a pill you take by mouth, either on its own or in combination with other approved cancer medicines. You'll need to report any side effects or changes in your health to the study team. The total duration of your participation will depend on which part of the study you are in and how you respond to the treatment, with ongoing follow-up to monitor your health. More specific details about the number of visits and exact tests would be provided by the study team.