A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes

NCT ID
NCT07748208
Registry status
Not yet recruiting
Study type
Not specified in the registry data
Phase
Phase 2
Sponsor
Hoffmann-La Roche

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 40 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

No study locations are listed in the registry data.

Study details

Start date
October 30, 2026
Primary completion date
June 15, 2029
First posted
August 5, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07748208
Registry last updated
September 16, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07748208 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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