Study on Inavolisib with CDK4/6 Inhibitor and Letrozole vs Placebo for Advanced Breast Cancer with Specific Mutations

Inclusion Criteria

• Men or women with confirmed breast cancer.
• Tumor must be hormone receptor-positive (ER-positive and/or progesterone receptor-positive) and HER2-negative.
• Advanced breast cancer that is either newly diagnosed or has returned after at least two years of previous hormone therapy without progression.
• Both breasts affected with HR-positive and HER2-negative cancer are eligible.
• Must meet specific biomarker requirements.
• Willing to provide a tumor tissue sample.
• Have measurable disease according to standard criteria.
• Good overall health with an ECOG performance status of 0 or 1.
• Adequate blood and organ function within 14 days before starting the study treatment.

Exclusion Criteria

• Pregnant or breastfeeding, or planning to become pregnant during the study or within the required contraception period.
• Have metaplastic breast cancer.
• Have received any prior treatment for advanced breast cancer.
• Have Type 2 diabetes needing ongoing treatment or any history of Type 1 diabetes.
• Have a history of cancer spread to the brain or spinal cord lining.
• Have untreated or active cancer spread to the brain, unless previously treated.
• Have active eye inflammation or a history of certain eye conditions.
• Have active lung disease with symptoms.
• Have a history of or active inflammatory bowel disease.
• Have active bowel inflammation.
• Have had a stem cell or bone marrow transplant.
• Have used certain strong medications affecting liver enzymes within 4 weeks before starting the study treatment.