Open AccessTrilaciclib prior to gemcitabine plus carboplatin for metastatic triple-negative breast cancer: phase III PRESERVE 2
Author(s) -
Shom Goel,
Antoinette R. Tan,
Hope S. Rugo,
Philippe Aftimos,
Zoran Andrić,
Andrew P. Beelen,
Jingshan Zhang,
John S. Yi,
Rajesh Malik,
Joyce O’Shaughnessy
Publication year - 2022
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2022-0773
Subject(s) - medicine , carboplatin , gemcitabine , triple negative breast cancer , metastatic breast cancer , chemotherapy , oncology , breast cancer , cancer , cisplatin
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).