This study is looking at a new treatment approach for advanced metastatic breast cancer (cancer that has spread to other parts of the body) in patients who have already tried other therapies. It compares a treatment called the Bria-IMT regimen (which includes SV-BR-1-GM, Cyclophosphamide, and Interferon) combined with Retifanlimab (a checkpoint inhibitor, a type of drug that helps your immune system fight cancer) against treatments chosen by your doctor. The study aims to see if the Bria-IMT regimen with Retifanlimab helps people live longer. You might be able to join if you are 18 or older, have metastatic breast cancer, and have already received other treatments that were not successful. The study plans to enroll 404 participants, but its current status is unclear.

Study design

This is a multicenter, randomized, open-label study comparing the Bria-IMT regimen plus Retifanlimab to physician's choice treatments, and initially to the Bria-IMT regimen alone. It plans to enroll 404 participants.

What's involved

Treatment cycles occur every 3 weeks for the Bria regimen arms, with imaging assessments every 6 weeks for the first two assessments, then every 8 weeks thereafter. Treatment continues as long as the disease does not worsen or major safety issues do not arise.

Compensation

Not stated in the trial record.

Follow-up

Overall survival will be measured for up to 60 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.