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

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06027268
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Triple-Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Sep 7, 2023
Start date
Jan 10, 2024
Status verified
Aug 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin
    Trilaciclib is an agent that helps protect the bone marrow from the side effects of chemotherapy. It is given as an intravenous (IV) infusion over 30 minutes prior to gemcitabine and carboplatin. Gemcitabine is given IV over 30 minutes. Carboplatin is given over 30 minutes. Trilaciclib, gemcitabine and carboplatin are given on Days 1 and 8 every 21 days. Pembrolizumab is given IV over 30 minutes on Day 1 every 21 days.

Primary Outcome Measure

Objective Response [ Time Frame: 6 months (initiation of protocol directed therapy until either a partial response is achieved or treatment discontinuation) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Levine Cancer InstituteCharlotteNorth Carolina28204-

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By research site
Levine Cancer Institute· Charlotte, NC

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