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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Rani
Bansal
Protocol Number
PRO00118609
NCT ID
NCT06790693
Phase
III
Enrollment Status
Pending Open to Enrollment