Trilaciclib prior to gemcitabine plus carboplatin for metastatic triple-negative breast cancer: phase III PRESERVE 2
Shom Goel, Antoinette R Tan, Hope S Rugo, Philippe Aftimos, Zoran Andrić, Andrew Beelen, Jingshan Zhang, John S Yi, Rajesh Malik, Joyce O'Shaughnessy, Shom Goel, Antoinette R Tan, Hope S Rugo, Philippe Aftimos, Zoran Andrić, Andrew Beelen, Jingshan Zhang, John S Yi, Rajesh Malik, Joyce O'Shaughnessy
Abstract
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 stem 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, double-blind, 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. Clinical Trial Registration: NCT04799249 (ClinicalTrials.gov).
Keywords: CDK4/6 inhibitor; carboplatin; gemcitabine; immunotherapy; metastatic; overall survival; patient-reported outcome; phase III; trilaciclib; triple-negative breast cancer.
Source: PubMed