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This combination therapy consists of pyrotinib maleate, dalpiciclib isethionate, and standard endocrine therapy. Pyrotinib is an irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) that targets the intracellular kinase domains of EGFR (HER1), HER2, and HER4. Dalpiciclib (also known as darcilib or SHR6390) is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which are key regulators of the cell cycle. Standard endocrine therapy typically involves aromatase inhibitors or estrogen receptor antagonists. This triplet regimen is being evaluated as a neoadjuvant treatment for patients with hormone receptor-positive (HR+) and HER2-low expression breast cancer to improve pathological complete response rates. The development is primarily associated with Jiangsu Hengrui Pharmaceuticals (the drug manufacturer) and clinical investigation by The First Affiliated Hospital of Xiamen University.
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