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Giredestrant + samuraciclib is an investigational combination therapy for hormone receptor-positive (HR+), HER2-negative advanced breast cancer. Giredestrant is an oral selective estrogen receptor degrader (SERD) that antagonizes and degrades the estrogen receptor, thereby inhibiting estrogen-driven tumor growth. Samuraciclib is a first-in-class, oral small molecule inhibitor of cyclin-dependent kinase 7 (CDK7), which plays a key role in cell cycle regulation and transcriptional control of oncogenes. The combination aims to overcome resistance to prior CDK4/6 inhibitor therapies by targeting both the estrogen signaling pathway and cell cycle progression. Clinical trials have shown improved progression-free survival in biomarker-selected populations—specifically patients without TP53 mutations or liver metastases—suggesting this regimen may be particularly effective for these subgroups[1][3][5]. The combination is being developed by Carrick Therapeutics in collaboration with Roche.
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