OncRef

Clinical Trial: NCT06027268

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Wake Forest University Health Sciences
Information Provided By:Wake Forest University Health Sciences
Last Update Posted:2026-08-20

Study Overview

Brief 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

Official Title

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

Conditions

Metastatic Triple-Negative Breast Cancer

Intervention / Treatment

  • Drug: Trilaciclib
  • Drug: Pembrolizumab
  • Drug: Gemcitabine
  • Drug: Carboplatin

Other Study ID Numbers

  • IRB00095334
  • LCI-BRE-MTN-TPGC-001

Start Date (Actual)

2024-01-10

Primary Completion Date (Estimated)

2027-08

Study Completion Date (Estimated)

2027-08

Enrollment (Estimated)

36

Study Type

Interventional

Phase

Phase 2