RecruitingBreast CancerDiabetes Type II
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
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.
Sponsor: Hoffmann-La Roche
You may qualify 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 qualify 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
Where it's recruiting
District of Columbia
Washington D.C.
Georgia
Atlanta
Nebraska
Grand Island · Omaha
New York
Mineola · New York
West Virginia
Morgantown
Source: ClinicalTrials.gov · NCT07748208 · last updated 2026-10-20