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

RecruitingPhase 2

A Phase II Prospective, Open-Label Safety Study of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer and Type 2 Diabetes

Who can join

Ages 18 and older · All sexes

Full 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

About the 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.

What is being tested

Sponsor: Hoffmann-La Roche · Participants: 40 · Started: Nov 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07748208

Locations in the U.S.

CaliforniaCommunity Cancer Institute (CCI), Clovis
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente, Torrance
District of ColumbiaMedStar Washington Hosp Center, Washington D.C.
GeorgiaEmory University Hospital, Atlanta
Emory University Hospital Midtown, Atlanta
Grady Memorial Hospital, Atlanta
NebraskaNebraska Cancer Specialists St Francis - Grand Island, Grand Island
Nebraska Cancer Specialists, Omaha
New YorkNYU Langone Hospital Long Island Clinical Research, Mineola
NYU Langone?s Perlmutter Cancer Center - 160 E 34th St, New York
TennesseeWest Cancer Center & Research Institute, Germantown
West VirginiaWest Virginia University, Morgantown

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.