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This investigational combination therapy is a triplet regimen being evaluated for the treatment of HR+/HER2- recurrent metastatic breast cancer with visceral metastasis. It consists of dalpiciclib (SHR6390), a highly selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) developed by Jiangsu Hengrui Pharmaceuticals; metronomic capecitabine, an oral chemotherapy agent that acts as a prodrug of 5-fluorouracil; and endocrine therapy (either an aromatase inhibitor or fulvestrant). The regimen is currently the subject of a Phase 3 randomized controlled trial sponsored by Fujian Cancer Hospital. Dalpiciclib interrupts the cell cycle at the G1/S phase transition, while capecitabine provides sustained cytotoxic pressure through metronomic dosing, and endocrine therapy targets the underlying hormonal drivers of the cancer.
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