Trastuzumab and pertuzumab based regimen are the standard of care for patients with human
epidermal growth factor receptor 2 (HER2) -positive metastatic breast cancer (MBC),
significantly improving survival outcomes. However, an unmet medical need remain for patients
with disease refractoriness and recurrence. Interestingly, HER2 over-expression is associated
with upregulation of vascular endothelial growth factor (VEGF) in cancer cells in vitro and
in vivo. Preclinical studies indicated that VEGF expression is positively regulated by HER2
signaling. In the clinical setting, HER2 over-expression correlated significantly with VEGF
over- expression in samples from patients with breast cancer. There is, therefore, a biologic
rationale for targeting both HER2 and VEGF pathways in patients with HER2-positive breast
cancer.
PURPOSE: The hypothesis that justifies this research is that the addition of Thero2-01S22 as
add-on therapy on top of first line anti-HER2 targeted treatment will improve the efficacy of
anti-HER2 targeted containing regimen at the metastatic setting for breast cancer.