A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
