Phase II Study of Inavolisib Plus Ribociclib and Fulvestrant Compared to Placebo Plus Ribociclib and Fulvestrant in Adults With Endocrine-Resistant HR-Positive, HER2-Negative Advanced Breast Cancer with Specific Genetic Features

What this Trial Is About

This research aims to evaluate the effectiveness and safety of a combination of three drugsinavolisib, ribociclib, and fulvestrantcompared to a placebo combined with ribociclib and fulvestrant. It focuses on people with advanced breast cancer that is resistant to endocrine therapy, specifically those with hormone receptor-positive, HER2-negative disease who have certain genetic markers related to chromosome 8p loss and no PIK3CA mutation. The study is conducted as a phase II, randomized, double-blind, placebo-controlled trial to explore treatment options in this patient group. Participants are randomly assigned to receive either inavolisib along with ribociclib and fulvestrant or a placebo with ribociclib and fulvestrant. Each drug is given according to a specific schedule outlined in the study protocol, though exact dosing details are not provided here. This setup allows researchers to compare the results and safety profiles of the combination treatment against the placebo combination over the course of the study. Throughout the trial, participants undergo regular assessments to measure treatment response, including the percentage of participants with confirmed objective response, progression-free survival, overall survival, duration of response, and clinical benefit rate. The study also tracks adverse events and patient-reported side effects using validated questionnaires. These evaluations may continue for up to approximately two years, ensuring thorough monitoring of both effectiveness and safety during the participants involvement.

A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer