dalpiciclib + endocrine therapy + trastuzumab

This combination therapy is an experimental treatment regimen being investigated by Fudan University in the Phase III Cinderella trial (NCT06104111). It consists of the CDK4/6 inhibitor dalpiciclib, the anti-HER2 monoclonal antibody trastuzumab, and standard endocrine therapy (such as aromatase inhibitors or tamoxifen). The regimen is specifically designed for patients with stage I, hormone receptor-positive (HR+), and HER2-positive (HER2+) breast cancer with lymph node-negative disease. The primary objective of the study is to evaluate whether this targeted combination can effectively replace traditional cytotoxic chemotherapy, thereby reducing treatment-related toxicity while maintaining high rates of invasive disease-free survival. Dalpiciclib inhibits the cyclin-dependent kinases 4 and 6 to induce cell cycle arrest, while trastuzumab targets the HER2 receptor to inhibit downstream proliferative signaling, and endocrine therapy suppresses estrogen-mediated tumor growth.

Other names

CDK4/6 inhibitor combined therapy-Fudan University-breast cancerCDK 4/6 inhibitor combined therapy (omit chemo)Cinderella trial regimen