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

Journal Article (Journal Article;Review)

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 (

Full Text

Duke Authors

Cited Authors

  • Goel, S; Tan, AR; Rugo, HS; Aftimos, P; Andrić, Z; Beelen, A; Zhang, J; Yi, JS; Malik, R; O'Shaughnessy, J

Published Date

  • September 22, 2022

Published In

PubMed ID

  • 36135712

Electronic International Standard Serial Number (EISSN)

  • 1744-8301

Digital Object Identifier (DOI)

  • 10.2217/fon-2022-0773


  • eng

Conference Location

  • England