Investigators Initiate Post-Trastuzumab Trial of GLSI-100 in Patients With Invasive Breast Cancer
Investigators hope to duplicate promising phase 2b trial results with an experimental peptide vaccine in a population of nearly 500 patients with human epidermal growth factor receptor 2 breast cancer.
Patients who have progressed on trastuzumab, including trastuzumab biosimilars, will be enrolled in a phase 3 trial of a promising immunotherapy for the treatment of breast cancer recurrence, according to an
The trial will evaluate the safety and efficacy of human epidermal growth factor receptor 2 (HER2)/neu peptide GLSI-100 in patients with residual disease or high-risk pathologic complete response (pCR) after neo-adjuvant and postoperative adjuvant anti-HER2 therapy.
GLSI-100 incorporates granulocyte-macrophage colony-stimulating factor and sargramostim, which contribute to the development of white blood cells and cells that become platelets; and GP2, which is a 9 amino acid transmembrane peptide of the HER2/neu protein. This combination is believed to stimulate an immune response targeting HER2/neu–expressing cancers.
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