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Recruiting Phase 2

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

NCT07748208 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2026-10-30
Last updated
2026-10-20

Condition(s) studied

Breast CancerDiabetes Type II

Investigational drug(s) / intervention(s)

Inavolisib →Fulvestrant →Palbociclib →

Inavolisib: Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.

Fulvestrant: Participants will receive intramuscular (IM) fulvestrant on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle.

Palbociclib: Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percentage of Participants With Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1 — Up to approximately 21 months
  • Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1 — Up to approximately 21 months
  • Percentage of Participants with AEs After Cycle 1 — Up to approximately 21 months

Trial sites (10)

FacilityCityRegionStatus
MedStar Washington Hosp Center Washington D.C. District of Columbia Recruiting
Grady Memorial Hospital Atlanta Georgia Recruiting
Emory University Hospital Midtown Atlanta Georgia Recruiting
Emory University Hospital Atlanta Georgia Recruiting
Nebraska Cancer Specialists St Francis - Grand Island Grand Island Nebraska Recruiting
Nebraska Cancer Specialists Omaha Nebraska Recruiting
NYU Langone Hospital Long Island Clinical Research Mineola New York Recruiting
NYU Langone?s Perlmutter Cancer Center - 160 E 34th St New York New York Recruiting
West Virginia University Morgantown West Virginia Recruiting
Pan American Center for Oncology Trials, LLC Dorado Puerto Rico Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07748208 on ClinicalTrials.gov ↗ ← All trials in the USA