Trilaciclib prior to gemcitabine plus carboplatin for metastatic triple-negative breast cancer: phase III PRESERVE 2

Triple-negative breast cancer (TNBC) is an aggressive malignancy for which cytotoxic chemotherapy remains the backbone of treatment. Trilaciclib is an intravenous cyclin-dependent kinase 4/6 inhibitor that induces transient cell cycle arrest of hematopoietic stern and progenitor cells and immune cells during chemotherapy exposure, protecting them from chemotherapy-induced damage and enhancing immune activity. Administration of trilaciclib prior to gemcitabine plus carboplatin (GCb) significantly improved overall survival (OS) compared with GCb alone in an open-label phase II trial in patients with metastatic TNBC, potentially through protection and direct activation of immune function. The randomized, doubleblind, placebo-controlled, phase III PRESERVE 2 trial will evaluate the efficacy and safety of trilaciclib administered prior to GCb in patients with locally advanced unresectable or metastatic TNBC.

Automated summary

Trilaciclib, a cyclin-dependent kinase 4/6 inhibitor, has shown promising results in improving overall survival in patients with triple-negative breast cancer (TNBC) when administered prior to chemotherapy. It protects hematopoietic stem and progenitor cells and immune cells from chemotherapy-induced damage, while enhancing immune activity. The ongoing phase III trial, PRESERVE 2, aims to evaluate the efficacy and safety of Trilaciclib in patients with locally advanced unresectable or metastatic TNBC.