NCI-2022-03768

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 focused on a specific protein called HER2/neu that is found in some breast cancers. They want to test a new treatment called GLSI-100, which is made from a combination of two things: a peptide called GP2 and a protein called GM-CSF. They are looking at people who have breast cancer with this HER2/neu protein and have finished some initial treatments. These treatments include Trastuzumab, which is a kind of medicine used to target the HER2/neu protein. The people in this study either have a small amount of leftover cancer (called residual disease) or are at high risk for the cancer coming back. This might be because they still have some cancer-related genetic material (PCR) even after their treatments. The study wants to see if GLSI-100 can help people who still have some cancer left or are at high risk of the cancer returning, even after they've had treatments like Trastuzumab. They'll be checking how well the treatment works and whether it's safe.

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT05232916

NCI-2022-03768

Clinical Trial Site: Columbia

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