Breast Cancer Clinical Trial
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
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.
Full Description
The posted results represent the final results of Study G1T28-04, a Phase 2 study of the safety, efficacy and pharmacokinetics of trilaciclib (G1T28) in patients with locally recurrent/metastatic triple negative breast cancer receiving gemcitabine and carboplatin chemotherapy.
The final myelopreservation efficacy results are reported from database lock 1 ([DBL1], data cut-off [DCO] date of 30 July 2018). Final anti-tumor efficacy (ORR, PFS), and final summary exposure and safety data are reported from database lock 2 ([DBL2], DCO 28 June 2019) which occurred to support filing of the trilaciclib New Drug Application (NDA). Final overall survival (OS) data are reported from the final database lock which occurred on 17 July 2020 (with a last patient last visit date of 28 February 2020).
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
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There are 51 Locations for this study
Tucson Arizona, 85704, United States
Burbank California, 91505, United States
San Diego California, 92123, United States
Whittier California, 90603, United States
Colorado Springs Colorado, 80909, United States
Lakewood Colorado, 80228, United States
Fort Myers Florida, 33916, United States
Plantation Florida, 33324, United States
Saint Petersburg Florida, 33705, United States
Tampa Florida, 33612, United States
West Palm Beach Florida, 33401, United States
Boise Idaho, 83706, United States
Arlington Heights Illinois, 60005, United States
Indianapolis Indiana, 46250, United States
Baltimore Maryland, 21201, United States
Towson Maryland, 21204, United States
Kansas City Missouri, 64113, United States
Las Vegas Nevada, 89128, United States
Charlotte North Carolina, 28204, United States
Winston-Salem North Carolina, 27103, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Austin Texas, 75231, United States
Austin Texas, 78745, United States
Bedford Texas, 76022, United States
Dallas Texas, 75246, United States
El Paso Texas, 79902, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78217, United States
Tyler Texas, 75701, United States
Tyler Texas, 75702, United States
Charlottesville Virginia, 22908, United States
Fairfax Virginia, 22031, United States
Virginia Beach Virginia, 23456, United States
Tacoma Washington, 98405, United States
Edegem , 10 26, Belgium
Sofia , 1000, Bulgaria
Sofia , 1330, Bulgaria
Sofia , 1756, Bulgaria
Varna , 9000, Bulgaria
Osijek , 31000, Croatia
Varazdin , 42000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Bitola , 7000, North Macedonia
Skopje , 1000, North Macedonia
Belgrade , 11000, Serbia
Belgrade , 11070, Serbia
Kragujevac , 34000, Serbia
Nis , 18000, Serbia
Sremska Kamenica , 21204, Serbia
Banská Bystrica , 974 0, Slovakia
Košice , 040 0, Slovakia
Maribor , 2000, Slovenia
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