Inavolisib + Fulvestrant ± Palbociclib for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for adults with advanced HR-positive, HER2-negative breast cancer that has a PIK3CA mutation and type 2 diabetes (well-controlled without insulin). Participants must not have had prior treatment for advanced disease, need to be in good general health, and have working major organs.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Fulvestrant
- Inavolisib
- Palbociclib
Trial Overview
The study tests the safety of combining inavolisib and fulvestrant, with or without palbociclib. All participants receive these drugs in different combinations to see how safe they are together for people with this specific type of breast cancer and diabetes.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive inavolisib and fulvestrant (and some participants palbociclib) as outlined in the intervention section.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
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