BriaCell Expands Phase 3 Metastatic Breast Cancer Study With Major New Clinical Sites

Prominent Institutions Join as Study Grows to 79 Sites Across 23 States

BriaCell Therapeutics Corp. (NASDAQ: BCTX, TSX: BCT) announced a significant milestone in its pivotal Phase 3 clinical trial for metastatic breast cancer (MBC) by welcoming leading centers Dartmouth Cancer Center, Cedars-Sinai Medical Center, and the Winship Cancer Institute of Emory University. With their addition, the trial now actively enrolls patients across 79 sites in 23 states—a substantial expansion aimed at accelerating patient recruitment and gathering robust clinical data.

Study Overview: Targeting Unmet Medical Needs in MBC

This large-scale national effort focuses on BriaCell’s lead candidate, Bria-IMT, in combination with an immune checkpoint inhibitor. The trial pits this combination against physician's choice of treatment in patients with advanced metastatic breast cancer. The ultimate goal is to measure improvements in overall survival (OS) as the primary endpoint, comparing Bria-IMT’s performance to existing therapies once 144 patient events are reached.

Broader Clinical Support Reflects Confidence in Bria-IMT Regimen

The list of active participants already included notable centers such as Mayo Clinic, Smilow Cancer Hospital at Yale, Sylvester Comprehensive Cancer Center, and Texas Oncology-Baylor Charles A. Sammons Cancer Center. The engagement from both major academic and community clinics signals growing trust in BriaCell’s novel immunotherapy platform. As Dr. William V. Williams, President & CEO, stated, “The strong engagement... underscores confidence in BriaCell's novel technology.”

Regulatory Progress: Fast Track Designation and Approval Pathway

BriaCell’s trial is especially noteworthy given that the Bria-IMT combination has already received FDA Fast Track designation. Should the interim analysis—triggered once 144 patient events are recorded—demonstrate positive results, BriaCell could move swiftly toward seeking full approval and marketing authorization, bringing a new option to patients facing advanced metastatic breast cancer.

What’s Next? Data on the Horizon and Market Implications

BriaCell expects to report top line results from the trial as early as the first half of 2026. This timeline, coupled with the broadened network of clinical partners, puts the company in a strong position to generate meaningful evidence and potentially shift the landscape for metastatic breast cancer treatment.

Takeaway: Momentum Grows in Immunotherapy for Breast Cancer

With a widened clinical footprint and imminent data catalysts, BriaCell’s Phase 3 trial of Bria-IMT in metastatic breast cancer continues to gather steam. While uncertainties and regulatory hurdles remain—as with any late-stage trial—the breadth of support from major institutions highlights the medical community’s keen interest in the potential of novel immunotherapies. For those following oncology breakthroughs or looking ahead to emerging treatments, this is a story worth watching as results near in 2026.

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