Stony Brook Cancer Center trials vaccine for HER2-positive breast cancer recurrence prevention
Updated
Updated · Newsday · Apr 25
Stony Brook Cancer Center trials vaccine for HER2-positive breast cancer recurrence prevention
9 articles · Updated · Newsday · Apr 25
Stony Brook is the only Long Island site among 160 worldwide in the FLAMINGO-01 Phase III trial, enrolling patients for a vaccine involving six initial injections and five boosters over several months.
The experimental vaccine, developed by Greenwich LifeSciences, aims to reduce the risk of metastatic disease in early-stage HER2-positive breast cancer patients by preventing cancer from returning and spreading beyond the breast.
Participants are closely monitored throughout the trial, and doctors emphasize the importance of clinical trial involvement for advancing breast cancer treatments and improving patient outcomes.
After a decade of treatment, what does it feel like to get a cancer vaccine?
If this cancer vaccine works, who will actually be able to afford it?
Beyond breast cancer, which major cancers are closest to having a preventive vaccine?
Is the new vaccine's 83% recurrence reduction based on gold-standard data?
How are scientists 'supercharging' the immune system for long-term cancer memory?
Why did the promising cancer vaccine company receive a Nasdaq non-compliance notice?
FLAMINGO-01 Phase III Trial Shows Up to 80% Reduction in HER2-Positive Breast Cancer Recurrence with GLSI-100 Vaccine
Overview
The FLAMINGO-01 Phase III trial for the GLSI-100 breast cancer vaccine has advanced significantly in 2026, building on the FDA Fast Track designation granted in 2024 and positive Phase 2b results showing up to 80% recurrence reduction in high-risk patients. Key milestones include FDA approval in January 2026 of the first commercial-scale vaccine batch, which enabled broader trial deployment across 40 US sites, and European regulatory approval in late 2025 to expand the trial to Ireland. The trial’s open-label arm for non-HLA-A*02 patients is fully enrolled and showing encouraging early trends. Final results are expected by 2027-2028 and could transform the standard of care for HER2-positive breast cancer.