Bria-IMT + CPI for Advanced Breast Cancer
(BRIA-ABC Trial)
Trial Summary
What is the purpose of this trial?
This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot be on certain prohibited medications. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What data supports the effectiveness of the treatment Bria-IMT + CPI for Advanced Breast Cancer?
The research highlights that modern immunotherapy strategies, like checkpoint blockade, have shown promising results in breast cancer treatment, particularly when combined with other therapies. For example, combining atezolizumab with nab-paclitaxel improved progression-free survival in metastatic triple negative breast cancer, suggesting that similar combination strategies could enhance the effectiveness of treatments like Bria-IMT + CPI.12345
What makes the Bria-IMT + CPI treatment for advanced breast cancer unique?
The Bria-IMT + CPI treatment is unique because it combines Retifanlimab, a checkpoint inhibitor that helps the immune system attack cancer cells, with SV-BR-1-GM, a vaccine designed to stimulate an immune response specifically against breast cancer cells. This combination aims to enhance the body's immune response to target and control advanced breast cancer more effectively than traditional treatments.13678
Research Team
Giuseppe Del Priore, MD MPH
Principal Investigator
BriaCell Therapeutics
Eligibility Criteria
This trial is for adults over 18 with advanced metastatic or locally recurrent breast cancer who have no other treatment options. Eligible patients must have failed prior therapy, not be suitable for local treatments, and meet specific criteria if they have brain metastases. They cannot join if they've had recent chemotherapy, radiotherapy, surgery, certain abnormal lab values, a history of other malignancies or immune conditions, unresolved toxicity from previous therapies, or are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Bria-IMT regimen with or without CPI, or Treatment of Physician's Choice (TPC) in cycles every 3 weeks
Imaging Assessment
Imaging assessments occur every 6 weeks for the first two cycles, then every 8 weeks thereafter
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- Interferon infiltration of the inoculation site
- Retifanlimab
- SV-BR-1-GM
Retifanlimab is already approved in United States for the following indications:
- Merkel cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
BriaCell Therapeutics Corporation
Lead Sponsor