BriaCell Therapeutics Corp. is advancing its pivotal Phase 3 clinical trial investigating Bria-IMT™ in combination with immune checkpoint inhibitors for patients with metastatic breast cancer (MBC). The study, designed to enroll up to 354 patients, is actively enrolling participants across 35 clinical sites.
The Phase 3 trial randomizes patients 1:1 to either the Bria-IMT™ combination regimen or the physician's choice of treatment. A smaller cohort (n=50) will receive Bria-IMT™ monotherapy. The primary endpoint of the study is overall survival (OS). An interim data analysis is scheduled to occur after 144 events (deaths) have been recorded.
Enrollment on Track
Dr. William V. Williams, President and CEO of BriaCell, stated, "We are very pleased to report that patient enrollment is on track for expected completion by mid-2025. We anticipate the interim data analysis of the ongoing pivotal Phase 3 study will confirm the effectiveness of the Bria-IMT™ combination regimen in patients with metastatic breast cancer who failed approved therapies."
Addressing Unmet Needs in Breast Cancer Treatment
Despite advancements in breast cancer therapies, it remains a leading cause of cancer-related deaths among women in the United States. Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer, emphasized the need for novel treatments, stating, "Despite multiple approved drugs, breast cancer remains the second-leading cause of cancer death in American women. We are determined to make our novel immunotherapy available to breast cancer patients whose medical needs remain unmet."
Trial Design and Endpoints
The Phase 3 study, identified as NCT06072612 on ClinicalTrials.gov, is designed to assess the efficacy and safety of the Bria-IMT™ combination therapy. The primary endpoint is overall survival. Secondary analyses will compare the Bria-IMT™ combination regimen against Bria-IMT™ monotherapy.
BriaCell recently reported positive Phase 2 survival data in a similar MBC patient population. The Bria-IMT™ combination regimen has been granted Fast Track designation by the FDA.
