Trilaciclib prior to gemcitabine plus carboplatin for metastatic triple-negative breast cancer: phase III PRESERVE 2
- Author(s)
- Goel, S; Tan, AR; Rugo, HS; Aftimos, P; Andric, Z; Beelen, A; Zhang, J; Yi, JS; Malik, R; O'Shaughnessy, J;
- Details
- Publication Year 2022-10,Volume 18,Issue #33,Page 3701-3711
- Journal Title
- Future Oncology
- Publication Type
- Protocol
- 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
- Humans; Antineoplastic Combined Chemotherapy Protocols/adverse effects; Carboplatin/therapeutic use; *Gemcitabine; Pyrimidines/therapeutic use; Randomized Controlled Trials as Topic; *Triple Negative Breast Neoplasms/pathology; CDK4/6 inhibitor; carboplatin; gemcitabine; immunotherapy; metastatic; overall survival; patient-reported outcome; phase III; trilaciclib; triple-negative breast cancer
- Department(s)
- Laboratory Research; Medical Oncology
- PubMed ID
- 36135712
- Publisher's Version
- https://doi.org/10.2217/fon-2022-0773
- Open Access at Publisher's Site
https://doi.org/10.2217/fon-2022-0773- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2024-10-31 04:55:09
Last Modified: 2024-10-31 04:56:11