Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
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ClinicalTrials.gov Identifier: NCT02978716 |
Recruitment Status :
Active, not recruiting
First Posted : December 1, 2016
Last Update Posted : January 27, 2021
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This is 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 patients with metastatic triple negative breast cancer.
The study is open-label and approximately 90 patients will be 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=30)
- Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=30)
- Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=30)
The study will include 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.
Condition or disease | Intervention/treatment | Phase |
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Triple-Negative Breast Neoplasms Breast Neoplasm Breast Cancer Triple-Negative Breast Cancer | Drug: Trilaciclib Drug: Gemcitabine Drug: Carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy |
Actual Study Start Date : | February 7, 2017 |
Actual Primary Completion Date : | July 30, 2018 |
Estimated Study Completion Date : | May 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1: Gemcitabine/Carboplatin
GC chemotherapy (gemcitabine 1000 mg/m2 and carboplatin AUC = 2 administered IV) on Days 1 and 8 in 21-day cycles.
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Drug: Gemcitabine
Gemcitabine Drug: Carboplatin Carboplatin |
Experimental: Group 2: Trilaciclib (G1T28) + Gemcitabine/Carboplatin
Trilaciclib (G1T28) IV prior to GC chemotherapy (gemcitabine 1000 mg/m2 and carboplatin AUC = 2 administered IV) on Days 1 and 8 in 21-day cycles.
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Drug: Trilaciclib
G1T28
Other Names:
Drug: Gemcitabine Gemcitabine Drug: Carboplatin Carboplatin |
Experimental: Group 3: Trilaciclib (G1T28) + Gemcitabine/Carboplatin
Trilaciclib (G1T28) IV on Days 1, 2, 8 and 9. GC chemotherapy (gemcitabine 1000 mg/m2 and carboplatin AUC = 2 administered IV) on Days 2 and 9 in 21-day cycles.
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Drug: Trilaciclib
G1T28
Other Names:
Drug: Gemcitabine Gemcitabine Drug: Carboplatin Carboplatin |
- Number of Treatment Related Adverse Event, including Abnormal Laboratory Events [ Time Frame: 18 months ]All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all patients receiving study drug from from the signing of the informed consent until 30 days after the last dose of study medication up to 18 months
- Tumor response based on RECIST, Version 1.1 [ Time Frame: 18 months ]
- Progression free survival (PFS) [ Time Frame: 27 months ]
- Overall survival (OS) [ Time Frame: 36 months ]
- Hematologic parameters [ Time Frame: 18 months ]Number of patients with treatment related abnormal laboratory assessments. Laboratory toxicities will be assessed using NCI CTCAE, Version 4.03
- Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Maximum Plasma Concentration (Cmax) [ Time Frame: 24 hours ]The observed peak plasma concentration determined from the plasma (Cmax)
- Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Area under Curve - plasma concentration (AUC) [ Time Frame: 24 hours ]Area under the plasma concentration-time curve (AUC)
- Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Plasma: terminal half life (T1/2) [ Time Frame: 24 hours ]Plasma- terminal half life (T1/2)
- Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Plasma - Volume of distribution [ Time Frame: 24 hours ]Volume of distribution in the terminal elimination phase (Vz)
- Incidence of chemotherapy dose reductions [ Time Frame: 18 months ]
- Incidence of dose interruptions overall [ Time Frame: 18 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed diagnosis of HR-negative, HER2-negative (locally recurrent or metastatic TNBC) breast cancer
- Available TNBC diagnostic tumor tissue (archived tissue allowed)
- Evaluable disease
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978716

Study Director: | Clinical Contact | G1 Therapeutics, Inc. |
Responsible Party: | G1 Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02978716 |
Other Study ID Numbers: |
G1T28-04 2016-004466-26 ( EudraCT Number ) |
First Posted: | December 1, 2016 Key Record Dates |
Last Update Posted: | January 27, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Cancer CDK 4/6 Inhibitor Triple Negative Breast Cancer Metastatic |
Breast Neoplasms Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Gemcitabine Carboplatin Antineoplastic Agents |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |