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

NCT06027268 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-22

No results posted yet for this study

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

Conditions

  • Metastatic Triple-Negative Breast Cancer

Interventions

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)

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • G1 Therapeutics, Inc.

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Antoinette Tan, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2026-09-30
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027268 on ClinicalTrials.gov