Overview
This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.
Eligibility
Inclusion Criteria:
- Type 2 diabetes with laboratory fasting blood glucose \< 185 milligrams per deciliter (mg/dL) and HbA1c \<= 8% on any stable anti-hyperglycemic regimen excluding insulin short-term insulin dosing
- Eligible for triplet of inavolisib, fulvestrant and palbociclib: no prior systemic therapy for locally advanced unresectable or metastatic disease
- Confirmed diagnosis of HR+/HER2- breast cancer
- Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclusion Criteria:
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
- Metaplastic breast cancer
- Any history of Type 1 diabetes
- Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment
- Any history of leptomeningeal disease or carcinomatous meningitis
- Known and untreated, or active central nervous system (CNS) metastases Participants with a history of treated CNS metastases are eligible
- Active inflammatory or conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
- Symptomatic active lung disease
- History of active bowel inflammation or active inflammatory bowel disease
