NCT04799249

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

A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: G1 Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will have two separate cohorts (Cohort 1 and Cohort 2). Both cohorts will follow the same general study conduct/design with similar primary and key secondary endpoints and identical treatment arms. * Cohort 1 will evaluate patients receiving first-line therapy, regardless of programmed death-ligand 1 (PD-L1) status, who are programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy naïve. * Cohort 2 will evaluate PD-L1 positive patients receiving second-line therapy following prior PD-1/PD-L1 inhibitor therapy in the locally advanced unresectable/metastatic setting.

Conditions

• TNBC - Triple-Negative Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trilaciclib	Trilaciclib administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
DRUG	Placebo	Placebo administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
DRUG	Gemcitabine	Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle.
DRUG	Carboplatin	Carboplatin administered IV on Day 1 and Day 8 of each 21-day cycle.

Timeline

• Start date: 2021-05-14
• Primary completion: 2024-05-24
• Completion: 2024-05-24
• First posted: 2021-03-16
• Last updated: 2024-08-01

Locations

71 sites across 11 countries: United States, Australia, Bulgaria, China, France, Georgia, Moldova, Poland, Russia, Spain, Ukraine

Regulatory

• FDA-regulated drug study