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Dalpiciclib + fulvestrant is a combination therapy used for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer, particularly in patients who have relapsed or progressed on previous endocrine therapy. Dalpiciclib is an oral small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which are key regulators of cell cycle progression. Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to and accelerates the degradation of the estrogen receptor, thereby inhibiting estrogen signaling. The combination has demonstrated significant improvement in progression-free survival compared to fulvestrant alone, with an acceptable safety profile primarily characterized by hematological toxicities such as neutropenia and leukopenia[1][3][6][8]. The recommended phase III dose for dalpiciclib in this combination is 150 mg daily[1][10].
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