WO45654 (INAVO123)

What is the Purpose of this Study?

People in this study will be placed into two groups. One group will take three medicines, and the other group will take two medicines and a fake pill. All pills are taken by mouth. At first, visits happen every week, then every month. Some visits may take a long time. The study has different parts and can last up to 5 years, depending on how well the treatment works.

What is the Condition Being Studied?

This study is for people with advanced breast cancer that has not spread too far. Their cancer must have certain features: it responds to hormones, does not have HER2, and has a gene change called PIK3CA.

Who Can Participate in the Study?

You may be able to join this study if you are an adult with advanced breast cancer that has certain features. Your cancer must respond to hormones, not have HER2, and have a gene change called PIK3CA. You must be able to take two cancer medicines and follow birth control rules. You cannot join if you are pregnant or breastfeeding.

Age Group
Adults

What is Involved?

This study is testing a new medicine called inavolisib to see if it works better than a fake pill when used with two other cancer medicines. Doctors want to know if this mix helps people with a certain kind of advanced breast cancer. They are also checking if the treatment is safe and how well people respond to it.

Study Details

Full Title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy And Safety Of Inavolisib Plus A CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients with Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, Her2-Negative Advanced Breast Cancer
Principal Investigator
Assistant Professor of Medicine
Protocol Number
IRB: PRO00118609
NCT: NCT06790693
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF