Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
Condition: Triple-Negative Breast Neoplasms; Breast Neoplasm; Breast Cancer; Triple-Negative Breast Cancer
MeSH terms: Breast Neoplasms; Neoplasms; Triple Negative Breast Neoplasms
Intervention: Trilaciclib; Gemcitabine; Carboplatin
Intervention description: G1T28; Gemcitabine; Carboplatin
Intervention MeSH terms: Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; CDK 4/6 Inhibitor; Triple Negative Breast Cancer; Metastatic

Summary:

      This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in
      preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor
      efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for participants
      with metastatic triple negative breast cancer.

      The study was an open-label and 102 participants were randomly assigned (1:1:1 fashion) to 1
      of the 3 following treatment groups:

        -  Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=34)

        -  Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day
           cycles (n=33)

        -  Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of
           21-day cycles (n=35)

      The study included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up
      Phase. The Treatment Phase begins on the day of first dose with study treatment and completes
      at the Post-Treatment Visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of hormone receptor (HR)-negative, human epidermal growth factor
             receptor 2 (HER2)-negative (locally recurrent or metastatic TNBC) breast cancer

          -  Available TNBC diagnostic tumor tissue (archived tissue allowed)

          -  Evaluable disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

          -  Adequate organ function

          -  Predicted life expectancy of 3 or more months

        Exclusion Criteria:

          -  More than 2 prior chemotherapy regimens for locally recurrent or metastatic TNBC. If >
             12 months have elapsed between the date of last adjuvant/neoadjuvant chemotherapy
             administration and first documented local or distant disease recurrence the therapy
             will not be considered a line of therapy in the locally recurrent or metastatic TNBC
             setting.

          -  CNS metastases or leptomeningeal disease requiring immediate treatment with radiation
             therapy or steroids.

          -  Investigational drug within 30 days of first trilaciclib (G1T28) dose

          -  Concurrent radiotherapy, radiotherapy within 14 days of first trilaciclib (G1T28) dose

          -  Cytotoxic chemotherapy within 3 weeks of first trilaciclib (G1T28) dose

          -  Prior hematopoietic stem cell or bone marrow transplantation