BriaCell Expands Phase 3 Breast Cancer Trial to Major U.S. Centers, Targets Enrollment Completion by 2026
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ; TSX: BCT), a clinical-stage biotechnology company pioneering targeted immunotherapies for advanced cancer, has announced the expansion of its pivotal Phase 3 clinical trial for advanced metastatic breast cancer (MBC) with the addition of two major cancer centers: Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven. Each institution brings with it an extensive network of 15 satellite locations, further extending the study’s reach and improving patient accessibility.
The ongoing Phase 3 trial, registered on ClinicalTrials.gov under identifier NCT06072612, is designed to evaluate the efficacy of BriaCell’s lead therapeutic candidate, Bria-IMT™, when combined with an immune checkpoint inhibitor (CPI), compared to standard-of-care treatments selected by physicians. The study aims to enroll patients with advanced metastatic breast cancer—an area with significant unmet clinical need despite existing therapeutic advancements.
According to BriaCell, patient enrollment for the study is progressing steadily and is anticipated to be completed by late 2025 or early 2026. The company projects that top-line data could be available as early as the first half of 2026, positioning Bria-IMT as a potential breakthrough in the management of late-stage breast cancer.
Dr. Giuseppe Del Priore, Chief Medical Officer of BriaCell, emphasized the strong interest among clinical investigators as a critical driver in expanding the trial footprint. “Clinical investigator interest in our Phase 3 study has exceeded our expectations, which has significantly expanded patient access to our treatment,” he noted. “This strong engagement reflects both the urgent unmet need in metastatic breast cancer and the dedication of our clinical partners.”
The trial’s primary endpoint is overall survival (OS), comparing the Bria-IMT plus CPI regimen against the physician’s choice of therapy. Interim data analysis will be conducted once 144 patient events (deaths) have occurred. A statistically significant survival benefit in the Bria-IMT arm could lead to full regulatory approval and commercial launch of the therapy.
BriaCell’s Phase 3 study builds on encouraging data from earlier clinical stages. Most recently, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the company reported positive survival outcomes from its Phase 2 study of Bria-IMT in a similar MBC population. The Phase 2 findings demonstrated promising overall survival results, contributing to heightened interest from the oncology research community.
Bria-IMT, BriaCell’s proprietary immunotherapy candidate, is an engineered, off-the-shelf, allogeneic cell line that stimulates the patient’s immune system to recognize and destroy cancer cells. The combination with immune checkpoint inhibitors, which block the cancer’s ability to evade immune detection, is designed to maximize anti-tumor activity by engaging multiple immune pathways.
This investigational regimen has already attracted attention from regulators. The U.S. Food and Drug Administration (FDA) has granted the Bria-IMT combination Fast Track designation, underscoring its potential to address an unmet medical need in a serious condition. Fast Track designation enables more frequent communication with the FDA and provides eligibility for accelerated approval and priority review, assuming positive clinical outcomes.
The inclusion of prestigious centers such as Smilow Cancer Hospital at Yale New Haven, a part of Yale New Haven Health and affiliated with Yale School of Medicine, along with the Los Angeles Cancer Network, known for its integrated oncology services across Southern California, marks a significant step forward for the trial. With each center supporting multiple satellite clinics, BriaCell now benefits from a geographically diverse and patient-accessible network, potentially reducing recruitment barriers and speeding up data collection.
Metastatic breast cancer remains one of the most challenging cancers to treat. Despite the introduction of targeted therapies and immunotherapies, many patients with advanced disease ultimately progress after multiple lines of treatment. BriaCell’s immunotherapeutic strategy aims to redefine the standard of care by providing a more personalized and immune-driven approach.
As the Phase 3 study progresses, BriaCell will continue to provide updates on enrollment milestones and interim data as they become available. If the final results confirm the survival benefit observed in earlier trials, Bria-IMT could become a vital new option for patients who currently have limited choices following disease progression on standard therapies.
With a promising clinical profile, regulatory momentum, and now an expanded trial footprint, BriaCell is positioning itself as a serious contender in the race to deliver next-generation immunotherapy solutions for breast cancer patients.
