ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)
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
• Written informed consent and HIPAA authorization for release of personal health information signed by the patient
• Male or female with locally advanced unresectable or metastatic TNBC
• Age ≥ 18 years at the time of consent
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 evaluated within 28 days prior to day 1 of study treatment
• Histological or cytological confirmation of estrogen negative and progesterone negative tumor, defined as \< 10% staining on immunohistochemistry (IHC) and human epidermal growth factor receptor type 2 (HER2)-negative, defined as HER 2 IHC 0 or 1+ or IHC 2+ with no amplification. Patients may be enrolled regardless of their PD-L1 (programmed death ligand-1) status.
• Measurable disease according to response evaluation criteria in solid tumors
• Demonstrate adequate organ function
• Female patients: All females of childbearing potential must have a negative serum β-human chorionic gonadotropin (hCG) test result at Screening and negative serum or urine pregnancy test results within 72 hours prior to day 1 of study treatment.
• Subject agrees to use contraception
⁃ As determined by the enrolling physician, the ability of the subject to understand and comply with study procedures for the entire length of the study
⁃ Tumor tissue: Willing to provide tumor tissue for research purposes
⁃ Subject has a life expectancy of ≥ 12 weeks