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RECRUITING
NCT07748208
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Inavolisib

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

DRUG

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.

DRUG

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