NCT06027268

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

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is an open label, single-arm, phase II trial designed to evaluate the efficacy of trilaciclib, pembrolizumab, gemcitabine and carboplatin in participants with locally advanced unresectable or metastatic triple-negative breast cancer. Pembrolizumab will be given for a maximum of 2 years. Eligible participants will receive the study treatment until disease progression, unacceptable toxicity, or withdrawal for any reason. A tumor biopsy will be collected from participants in which it can be safely obtained before the first dose of treatment, prior to Cycle 3 Day 1, and at the time of disease progression (optional). Blood specimens for correlative studies will be collected pre-treatment Cycle 1 Day 1, prior to treatment Cycle 2 Day 1, prior to treatment Cycle 3 Day 1, 3 months after the start of study treatment, and 6 months after the start of study treatment.

Conditions

• Metastatic Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Trilaciclib	IV infusion Day 1 and Day 8 every 21 days, at dose of 240 mg/m2
DRUG	Pembrolizumab	IV infusion Day 1 every 21 days, at dose of 200 mg
DRUG	Gemcitabine	IV infusion Day 1 and Day 8 every 21 days, at dose 1000 mg/m2
DRUG	Carboplatin	IV infusion Day 1 and Day 8 every 21 days, at dose area under curve (AUC) 2 (maximum of 300 mg)

Timeline

• Start date: 2024-01-10
• Primary completion: 2026-09-01
• Completion: 2027-03-01
• First posted: 2023-09-07
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study