Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
Stopped early · Phase 2
Conditions studied: Triple-Negative Breast Neoplasms, Breast Neoplasm, Breast Cancer, Triple-Negative Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02978716
- Run by
- G1 Therapeutics, Inc.
- People needed
- 102
- Starts
- 2017-02-02
- Expected to finish
- 2020-02-28
- Last updated by the study team
- 2022-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Disney Family Cancer Center — Burbank, California, United States
- Sharp Clinical Oncology — San Diego, California, United States
- Innovative Clinical Research Institute — Whittier, California, United States
- Memorial UC Health — Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers — Lakewood, Colorado, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Florida Cancer Research Institute, LLC. — Plantation, Florida, United States
- Florida Cancer Specialists - North (FCS North) — St. Petersburg, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Florida Cancer Specialists - East (FCS East) — West Palm Beach, Florida, United States
- Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
- Illinois Cancer Specialists — Arlington Heights, Illinois, United States
- Community Health Network — Indianapolis, Indiana, United States
- University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
- The University of Maryland St. Joseph Medical Center — Towson, Maryland, United States
- Saint Luke's Cancer Institute — Kansas City, Missouri, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Levine Cancer Center — Charlotte, North Carolina, United States
- Forsyth Memorial Hospital, Novant Health Oncology Specialists — Winston-Salem, North Carolina, United States
- Tennessee Oncology — Chattanooga, Tennessee, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- Texas Oncology-Dallas Presbyterian Hospital — Austin, Texas, United States
- Texas Oncology, P.A. — Austin, Texas, United States
- Texas Oncology, P.A. — Bedford, Texas, United States
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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