Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Ne⦠(NCT06027268) | Clinical Trial Compass
Active β Not RecruitingPhase 2
Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer
United States36 participantsStarted 2024-01-10
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
β. Written informed consent and HIPAA authorization for release of personal health information signed by the patient
β. Male or female with locally advanced unresectable or metastatic TNBC
β. Age β₯ 18 years at the time of consent
β. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 evaluated within 28 days prior to day 1 of study treatment
β. 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.
β. Measurable disease according to response evaluation criteria in solid tumors
β. Demonstrate adequate organ function
β. Female patients: All females of childbearing potential must have a negative serum Ξ²-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.
Exclusion criteria
β. More than 3 prior lines of chemotherapy for locally advanced unresectable or triple-negative metastatic disease
β. Prior therapy with the concurrent combination of gemcitabine and carboplatin in the metastatic setting
What they're measuring
1
Objective Response
Timeframe: 6 months (initiation of protocol directed therapy until either a partial response is achieved or treatment discontinuation)
. Active, symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis or CNS metastases that are progressing on screening magnetic resonance imaging (MRI) brain.
β. Prior systemic anti-cancer therapy within 3 weeks, prior stereotactic radiotherapy within 1 week, and radiation within 2 weeks of day 1 of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation to non-CNS disease.
β. Major surgery, defined by the investigator's discretion, within 3 weeks of day 1 of study treatment
β. Not recovered from all reversible acute toxic effects of prior therapy, including non-hematologic toxicities related to prior systemic therapy to β€ Grade 1. Participants with less than Grade 2 neuropathy or alopecia of any grade are an exception