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NCT06027268 · ClinicalTrials.gov record · last posted 2026-08-20

Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer

Study acronym: ToPCourT
StatusActive, Not Recruiting
PhasePhase 2
Started2024-01-10
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The goal of this phase II study is to test the combination of trilaciclib, pembrolizumab, gemcitabine, and carboplatin in locally advanced unresectable or metastatic triple-negative breast cancer. The main questions it aims to answer are: * to evaluate the anti-cancer efficacy (assess how well it works) * to evaluate the safety and tolerability (how well the body can handle the treatment) of this combination of anti-cancer therapy

Protocol amendment history 2 changes detected by DataLookout

2026-08-21
Primary completion pushed: 2026-09 → 2027-08
2026-08-21
Completion pushed: 2027-03 → 2027-08
Trial Details
NCT Number NCT06027268
Lead Sponsor Wake Forest University Health Sciences
Collaborators: Merck Sharp & Dohme LLC, G1 Therapeutics, Inc.
Conditions Metastatic Triple-Negative Breast Cancer
Enrollment 36 participants
Start Date 2024-01-10
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-20