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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
Sponsor: Hoffmann-La Roche
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-10-30
Completion Date
2029-09-30
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (10)
MedStar Washington Hosp Center
Washington D.C., District of Columbia, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Nebraska Cancer Specialists St Francis - Grand Island
Grand Island, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
NYU Langone Hospital Long Island Clinical Research
Mineola, New York, United States
NYU Langone?s Perlmutter Cancer Center - 160 E 34th St
New York, New York, United States
West Virginia University
Morgantown, West Virginia, United States
Pan American Center for Oncology Trials, LLC
Dorado, Puerto Rico