TACTIVE-U: an interventional safety and efficacy phase 1b/2, open-label umbrella study to investigate tolerability, pk, and antitumor activity of ARV-471 (pf-07850327), an oral proteolysis targeting chimera, in combination with other anticancer treatments in participants aged 18 years and over with er+ advanced or metastatic breast cancer, sub-study b (ARV-471 in combination with Ribociclib)

Description

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: * is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy * is sensitive to hormonal therapy (it is called estrogen receptor positive); and * is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study B: All participants will receive ARV-471 and a medicine called ribociclib. ARV-471 and ribociclib will be given at the same time by mouth, at home, 1 time a day. The experiences of people receiving the study medicine will be examined. This will help determine if the study medicine is safe and effective. Participants will continue to take ARV-471 and ribociclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks.

Resources and Links

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT05573555 Opens a new window