Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

Phase 3 Completed 194 enrolled G1 Therapeutics, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNBC.

Timeline

Start: 2021-05-14
Primary completion: 2024-05-24
Completion: 2024-05-24

Publications

Goel S, Tan AR, Rugo HS, Aftimos P, Andric Z, Beelen A, Zhang J, Yi JS, Malik R, O'Shaughnessy J. Trilaciclib prior to gemcitabine plus carboplatin for metastatic triple-negative breast cancer: phase III PRESERVE 2. Future Oncol. 2022 Oct;18(33):3701-3711. doi: 10.2217/fon-2022-0773. Epub 2022 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trilaciclib	Unknown	240 mg/m2	Intravenous
Background	Carboplatin	Small molecule	2 unknown	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

Summary

Timeline

Publications

Drugs

Indications