A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)

This study is testing an experimental vaccine called GLSI-100 to see if it helps prevent breast cancer from coming back. It is designed for patients who have already finished their standard treatments but are still at a high risk for the cancer to return.

You may be eligible if you have HER2-positive breast cancer and have completed your initial treatments, including surgery and trastuzumab. Participants generally need a specific genetic marker called HLA-A*02, though there is an additional group that does not require this.

Participants will receive a series of small injections under the skin over several months to train the immune system to fight cancer cells. You will be compared against a group receiving a placebo (a shot with no medicine) to see how well the vaccine works.

The study is currently recruiting volunteers at several locations in Alabama and Arizona. Since this is an interventional trial, you would need to visit these study centers for your scheduled injections and check-ups.