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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)

    Summary
    EudraCT number
    		 2020-004930-39
    Trial protocol
    		 FR   BG   PL   ES  
    Global end of trial date
    24 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2025
    First version publication date
    19 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    G1T28-208
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04799249
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    G1 Therapeutics, Inc.
    Sponsor organisation address
    700 Park Offices Dr. Suite 200 PO Box 110341 Research Triangle Park, North Carolina, United States, 27709
    Public contact
    Clinical Trial Information, G1 Therapeutics, Inc., 000 1919 213 9835, clinicalinfo@g1therapeutics.com
    Scientific contact
    Clinical Trial Information, G1 Therapeutics, Inc., 000 1919 213 9835, clinicalinfo@g1therapeutics.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Cohort 1: First-Line, programmed cell death protein 1 (PD-1)/ programmed death-ligand 1(PD-L1) Inhibitor-Naïve Population: To evaluate the effect of trilaciclib on overall survival (OS) compared with placebo Cohort 2: Second-line, Previously Treated with a PD-1/PD-L1 Inhibitor Population: To evaluate the effect of trilaciclib on OS compared with placebo
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles of Good Clinical Practice (GCP), including archiving of essential documents, and according to the International Council for Harmonisation (ICH) Harmonised Tripartite Guideline.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 May 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 22
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    United States: 22
    Country: Number of subjects enrolled
    Ukraine: 13
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Moldova, Republic of: 4
    Country: Number of subjects enrolled
    Georgia: 43
    Country: Number of subjects enrolled
    China: 37
    Country: Number of subjects enrolled
    Australia: 9
    Worldwide total number of subjects
    187
    EEA total number of subjects
    52
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    132
    From 65 to 84 years
    55
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 80 sites in Australia, Bulgaria, China, France, Georgia, Moldova, Poland, Russia, Spain, Ukraine, and the US, from 08 June 2021 (first subject enrolled) to 24 May 2024 (last subject last visit).

    Pre-assignment
    Screening details
    		 Subjects who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment. Of the 252 subjects screened, 65 were screen failures and 187 subjects were randomized to treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo + Gemcitabine + Carboplatin
    Arm description
    		 Subjects received placebo matching with Trilaciclib prior to chemotherapy on Day 1 and Day 8 of each 21-day cycles.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Chemotherapy
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg/m2 was administered intravenously (IV) on Day 1 and Day 8 of each 21-day cycle.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo matching with Trilaciclib was administered IV over 30 minutes prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Chemotherapy
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin with a target area under the curve (AUC)=2 was administered IV on Day 1 and Day 8 of each 21-day cycle.

    Arm title
    		 Trilaciclib + Gemcitabine + Carboplatin
    Arm description
    		 Subjects received Trilaciclib prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trilaciclib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trilaciclib 240 mg/m2 was administered IV over 30 minutes prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Chemotherapy
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg/m2 was administered IV on Day 1 and Day 8 of each 21-day cycle.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Chemotherapy
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin with a target area under the curve (AUC)=2 was administered IV on Day 1 and Day 8 of each 21-day cycle.

    Number of subjects in period 1
    		Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Started
    91
    96
    Completed
    0
    0
    Not completed
    91
    96
         Consent withdrawn by subject
    11
    16
         Death
    54
    50
         Other
    -
    1
         Study Terminated by Sponsor
    23
    25
         Lost to follow-up
    3
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + Gemcitabine + Carboplatin
    Reporting group description
    		 Subjects received placebo matching with Trilaciclib prior to chemotherapy on Day 1 and Day 8 of each 21-day cycles.

    Reporting group title
    Trilaciclib + Gemcitabine + Carboplatin
    Reporting group description
    		 Subjects received Trilaciclib prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.

    Reporting group values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin Total
    Number of subjects
    		 91 96 187
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 65 67 132
        From 65-84 years
    		 26 29 55
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.1 ( 11.40 ) 58.6 ( 11.10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 90 95 185
        Male
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo + Gemcitabine + Carboplatin
    Reporting group description
    		 Subjects received placebo matching with Trilaciclib prior to chemotherapy on Day 1 and Day 8 of each 21-day cycles.

    Reporting group title
    Trilaciclib + Gemcitabine + Carboplatin
    Reporting group description
    		 Subjects received Trilaciclib prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    The OS defined as time from randomization to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases). The effect of Trilaciclib on OS compared with placebo was evaluated. The intent-to-treat (ITT) population included all randomized subjects.
    End point type
    Primary
    End point timeframe
    From the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Months
        median (confidence interval 95%)
    17.8 (13.3 to 22.5)
    17.4 (12.4 to 21.3)
    Statistical analysis title
    		 Trilaciclib vs Placebo
    Statistical analysis description
    The hazard ratio (HR) and its confidence interval (CI) were generated using the Cox regression model accounting for stratification factors of PD-L1 status, disease-free interval, and region.
    Comparison groups
    Placebo + Gemcitabine + Carboplatin v Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.33
    Statistical analysis title
    		 Trilaciclib vs Placebo
    Statistical analysis description
    The HR and its CI were generated using the Cox regression model without accounting for stratification factors of PD-L1 status, disease-free interval, and region.
    Comparison groups
    Placebo + Gemcitabine + Carboplatin v Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.38

    Secondary: OS in PD-L1-positive subgroup

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    End point title
    		 OS in PD-L1-positive subgroup
    End point description
    The OS defined as time from randomization to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases). The effect of Trilaciclib on OS as compared with placebo in the PD-L1-positive subgroup was assessed. The ITT population included all randomized subjects. Only subjects with PD-L1-positive were analyzed. Here, 99999 indicates that the upper limit of 95% CI was not estimable due to small number of events.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    37
    37
    Units: Months
        median (confidence interval 95%)
    21.8 (14.9 to 26.0)
    23.1 (9.1 to 99999)
    No statistical analyses for this end point

    Secondary: OS in PD-L1-negative subgroup

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    End point title
    		 OS in PD-L1-negative subgroup
    End point description
    The OS defined as time from randomization to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases). The effect of Trilaciclib on OS as compared with placebo in the PD-L1-negative subgroup was assessed. The ITT population included all randomized subjects. Only subjects with PD-L1-negative were analyzed.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    54
    59
    Units: Months
        median (confidence interval 95%)
    14.9 (9.9 to 22.4)
    15.7 (11.9 to 20.9)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    The PFS using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), defined as time from randomization to disease progression or death due to any cause, whichever occurred first. The effect of Trilaciclib on PFS as compared with placebo was assessed. The ITT population included all randomized subjects. Only subjects with PFS event were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    65
    58
    Units: Months
        median (confidence interval 95%)
    6.4 (5.2 to 8.1)
    6.3 (4.4 to 8.3)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    Confirmed ORR [confirmed complete response (CR) or partial response (PR)] is defined as the percentage of subjects who achieved confirmed objective response based on the Response evaluable population. The anti-tumor activity of Trilaciclib as compared with placebo was assessed. The Response evaluable population included those subjects in the ITT population and had measurable (target) tumor lesion(s) at the baseline tumor assessment.
    End point type
    Secondary
    End point timeframe
    Up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    89
    95
    Units: Percentage of subjects
        number (confidence interval 95%)
    38.2 (28.1 to 49.1)
    29.5 (20.6 to 39.7)
    No statistical analyses for this end point

    Secondary: Clinical Benefit Rate (CBR)

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    End point title
    		 Clinical Benefit Rate (CBR)
    End point description
    The CBR is defined as the percentage of subjects with best overall response of confirmed CR, confirmed PR, or stable disease lasting 24 weeks or longer, based on the Response evaluable population. The anti-tumor activity of trilaciclib as compared with placebo was assessed. The Response evaluable population included those subjects in the ITT population and had measurable (target) tumor lesion(s) at the baseline tumor assessment.
    End point type
    Secondary
    End point timeframe
    Up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    89
    95
    Units: Percentage of subjects
        number (confidence interval 95%)
    52.8 (41.9 to 63.5)
    42.1 (32.0 to 52.7)
    No statistical analyses for this end point

    Secondary: Duration of objective response (DOR)

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    End point title
    		 Duration of objective response (DOR)
    End point description
    The DoR is defined as the time from the date when the objective response of CR or PR was first documented to the date that radiographic progressive disease is documented, or death, whichever comes first. The anti-tumor activity of Trilaciclib as compared with placebo was assessed. The Response evaluable population included those subjects in the ITT population and had measurable (target) tumor lesion(s) at the baseline tumor assessment.
    End point type
    Secondary
    End point timeframe
    Up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    89
    95
    Units: Months
        median (confidence interval 95%)
    8.3 (4.5 to 12.8)
    7.6 (6.2 to 17.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE is any unwanted medical occurrence that happens during or after the use of a treatment, regardless of its relation to the treatment. AEs can include side effects, abnormal test results, or other health issues. These events can vary in severity, from mild symptoms to more serious conditions. An SAE is a specific, more severe type of AE. It includes events that result in death, life-threatening situations, hospitalization, significant disability, or birth defects. An SAE may also involve events that require intervention to prevent these outcomes. The safety and tolerability of Trilaciclib compared with placebo were assessed. The safety population included all randomized subjects in the ITT population who received at least 1 dose of study drug. Common terminology criteria for adverse events = CTCAE; Discontinuation = DC; Adverse event of special interest = AESI; Trilaciclib/Placebo = t/p
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) through last dose + 30 days (Safety Follow-up Visit) (approximately 32.5 months)
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    89
    93
    Units: Subjects
        Any AE
    82
    86
        Any AE of CTCAE Grade ≥3
    73
    70
        Any AE of CTCAE Grade ≥4
    28
    14
        Any study drug-related AE
    78
    81
        Trilaciclib/placebo (t/p)-related AE
    53
    56
        Gemcitabine-related AE
    78
    78
        Carboplatin-related AE
    77
    80
        Any serious adverse event (SAE)
    12
    16
        Any t/p-related SAE
    3
    6
        Any gemcitabine-related SAE
    8
    10
        Any carboplatin-related SAE
    7
    10
        AE leading to DC of any study drug
    23
    21
        AE leading to t/p DC
    8
    15
        AE leading to gemcitabine DC
    11
    18
        AE leading to carboplatin DC
    20
    18
        T/p-related AE leading to DC of t/p
    5
    5
        AE leading to death
    1
    0
        AESI for trilaciclib
    10
    12
    No statistical analyses for this end point

    Secondary: Number of subjects with Trilaciclib infusion interruptions

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    End point title
    		 Number of subjects with Trilaciclib infusion interruptions
    End point description
    The safety and tolerability of Trilaciclib compared with placebo were assessed. The safety population included all randomized subjects in the ITT population who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    89
    93
    Units: Subjects
    0
    7
    No statistical analyses for this end point

    Secondary: Number of subjects with chemotherapy dose modifications

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    End point title
    		 Number of subjects with chemotherapy dose modifications
    End point description
    The safety and tolerability of Trilaciclib compared with placebo was assessed. The safety population included all randomized subjects in the ITT population who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    89
    93
    Units: Subjects
        Overall (any chemotherapy)
    57
    46
        Gemcitabine
    57
    46
        Carboplatin
    53
    42
    No statistical analyses for this end point

    Secondary: Relative dose intensity for gemcitabine and carboplatin

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    End point title
    		 Relative dose intensity for gemcitabine and carboplatin
    End point description
    The safety and tolerability of Trilaciclib compared with placebo was assessed. The safety population included all randomized subjects in the ITT population who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    89
    93
    Units: Percentage
    median (full range (min-max))
        Gemcitabine
    71.84 (27.10 to 99.55)
    75.50 (27.79 to 109.87)
        Carboplatin
    73.86 (23.32 to 119.47)
    76.75 (31.36 to 106.31)
    No statistical analyses for this end point

    Secondary: Duration of severe (Grade 4) neutropenia in Cycle 1

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    End point title
    		 Duration of severe (Grade 4) neutropenia in Cycle 1
    End point description
    The effects of trilaciclib on the neutrophil lineage compared with placebo was assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 (each cycle was 21 days)
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Days
        arithmetic mean (standard deviation)
    0.9 ( 2.74 )
    0.4 ( 1.91 )
    No statistical analyses for this end point

    Secondary: Number of subjects with severe (Grade 4) neutropenia

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    End point title
    		 Number of subjects with severe (Grade 4) neutropenia
    End point description
    The effects of trilaciclib on the neutrophil lineage compared with placebo was assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 (each cycle is 21 days) up to 14 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    26
    8
    No statistical analyses for this end point

    Secondary: Number of subjects with febrile neutropenia AEs

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    End point title
    		 Number of subjects with febrile neutropenia AEs
    End point description
    The effects of trilaciclib on the neutrophil lineage compared with placebo was assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with granulocyte-colony stimulating factor (G-CSF) administration

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    End point title
    		 Number of subjects with granulocyte-colony stimulating factor (G-CSF) administration
    End point description
    The effects of trilaciclib on the neutrophil lineage compared with placebo was assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    56
    56
    No statistical analyses for this end point

    Secondary: Number of subjects with Grade 3 or 4 decreased hemoglobin laboratory values

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    End point title
    		 Number of subjects with Grade 3 or 4 decreased hemoglobin laboratory values
    End point description
    The effects of trilaciclib on the red blood cell (RBC) lineage compared with placebo was assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    21
    17
    No statistical analyses for this end point

    Secondary: Number of subjects with red blood cell (RBC) transfusions

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    End point title
    		 Number of subjects with red blood cell (RBC) transfusions
    End point description
    The effects of Trilaciclib on the RBC lineage compared with placebo was assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    On or after Week 5 up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    12
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with erythropoiesis stimulating agent (ESA) administration

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    End point title
    		 Number of subjects with erythropoiesis stimulating agent (ESA) administration
    End point description
    The effects of Trilaciclib on the RBC lineage compared with placebo were assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    6
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with Grade 3 or 4 decreased platelet count laboratory values

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    End point title
    		 Number of subjects with Grade 3 or 4 decreased platelet count laboratory values
    End point description
    The effects of trilaciclib on the platelet lineage compared with placebo were assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    15
    14
    No statistical analyses for this end point

    Secondary: Number of subjects with platelet transfusions

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    End point title
    		 Number of subjects with platelet transfusions
    End point description
    The effects of trilaciclib on the platelet lineage compared with placebo were assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    3
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with at least one hospitalization due to chemotherapy-induced myelosuppression

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    End point title
    		 Number of subjects with at least one hospitalization due to chemotherapy-induced myelosuppression
    End point description
    The effects of trilaciclib on hospitalizations due to chemotherapy-induced myelosuppression compared with placebo were assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    5
    5
    No statistical analyses for this end point

    Secondary: Number of subjects with all-cause dose reductions

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    End point title
    		 Number of subjects with all-cause dose reductions
    End point description
    The effects of trilaciclib on chemotherapy dosing compared with placebo were assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    57
    46
    No statistical analyses for this end point

    Secondary: Number of subjects with all-cause cycle delays

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    End point title
    		 Number of subjects with all-cause cycle delays
    End point description
    The effects of trilaciclib on chemotherapy dosing compared with placebo were assessed. The ITT population included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 (first dose administration) up to 32.5 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    91
    96
    Units: Subjects
    56
    49
    No statistical analyses for this end point

    Secondary: Time to First Confirmed Deterioration of Fatigue (TTCD-fatigue)

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    End point title
    		 Time to First Confirmed Deterioration of Fatigue (TTCD-fatigue)
    End point description
    The effect of trilaciclib on subjects’ quality of life as measured by time to first confirmed deterioration of fatigue compared with placebo as measured by the functional assessment of chronic illness therapy - fatigue (FACIT-F) was planned to be assessed. Data was not collected due to insufficient subjects at the end of the study.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 (each cycle is 21 days) up to 14 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: Months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [1] - Data was not collected due to insufficient subjects at the end of the study
    [2] - Data was not collected due to insufficient subjects at the end of the study
    No statistical analyses for this end point

    Secondary: Change in Quality of Life, Fatigue, and Patient-Reported Outcomes

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    End point title
    		 Change in Quality of Life, Fatigue, and Patient-Reported Outcomes
    End point description
    The effect of Trilaciclib on chemotherapy-induced myelosuppression-related symptoms and functional limitations compared with placebo was planned to be assessed. Data was not collected due to insufficient subjects at the end of the study
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 (each cycle is 21 days) up to 14 months
    End point values
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: Score
        number (not applicable)
    Notes
    [3] - Data was not collected due to insufficient subjects at the end of the study
    [4] - Data was not collected due to insufficient subjects at the end of the study
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs are collected starting from the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 32.5 months
    Adverse event reporting additional description
    The safety population included all randomized subjects in the ITT population who received at least 1 dose of study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Placebo + Gemcitabine + Carboplatin
    Reporting group description
    		 Subjects received placebo matching with Trilaciclib prior to chemotherapy on Day 1 and Day 8 of each 21-day cycles.

    Reporting group title
    Trilaciclib + Gemcitabine + Carboplatin
    Reporting group description
    		 Subjects received Trilaciclib prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.

    Serious adverse events
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 93 (13.98%)
    17 / 96 (17.71%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 93 (0.00%)
    2 / 96 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Superior vena cava syndrome
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 93 (0.00%)
    2 / 96 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 93 (2.15%)
    4 / 96 (4.17%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 93 (1.08%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary thrombosis
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 93 (1.08%)
    2 / 96 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo + Gemcitabine + Carboplatin Trilaciclib + Gemcitabine + Carboplatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 93 (92.47%)
    88 / 96 (91.67%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    37 / 93 (39.78%)
    41 / 96 (42.71%)
         occurrences all number
    172
    166
    Alanine aminotransferase increased
         subjects affected / exposed
    38 / 93 (40.86%)
    23 / 96 (23.96%)
         occurrences all number
    104
    51
    White blood cell count decreased
         subjects affected / exposed
    24 / 93 (25.81%)
    33 / 96 (34.38%)
         occurrences all number
    113
    190
    Aspartate aminotransferase increased
         subjects affected / exposed
    34 / 93 (36.56%)
    22 / 96 (22.92%)
         occurrences all number
    84
    51
    Platelet count decreased
         subjects affected / exposed
    26 / 93 (27.96%)
    25 / 96 (26.04%)
         occurrences all number
    83
    88
    Lymphocyte count decreased
         subjects affected / exposed
    10 / 93 (10.75%)
    9 / 96 (9.38%)
         occurrences all number
    41
    40
    Blood alkaline phosphatase increased
         subjects affected / exposed
    9 / 93 (9.68%)
    9 / 96 (9.38%)
         occurrences all number
    15
    22
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    10 / 93 (10.75%)
    8 / 96 (8.33%)
         occurrences all number
    17
    13
    Weight decreased
         subjects affected / exposed
    5 / 93 (5.38%)
    1 / 96 (1.04%)
         occurrences all number
    9
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 93 (5.38%)
    0 / 96 (0.00%)
         occurrences all number
    5
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 93 (16.13%)
    7 / 96 (7.29%)
         occurrences all number
    16
    14
    Dizziness
         subjects affected / exposed
    7 / 93 (7.53%)
    6 / 96 (6.25%)
         occurrences all number
    8
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    59 / 93 (63.44%)
    57 / 96 (59.38%)
         occurrences all number
    211
    203
    Neutropenia
         subjects affected / exposed
    30 / 93 (32.26%)
    33 / 96 (34.38%)
         occurrences all number
    94
    109
    Thrombocytopenia
         subjects affected / exposed
    27 / 93 (29.03%)
    16 / 96 (16.67%)
         occurrences all number
    81
    47
    Leukopenia
         subjects affected / exposed
    11 / 93 (11.83%)
    3 / 96 (3.13%)
         occurrences all number
    62
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    19 / 93 (20.43%)
    24 / 96 (25.00%)
         occurrences all number
    27
    41
    Asthenia
         subjects affected / exposed
    18 / 93 (19.35%)
    20 / 96 (20.83%)
         occurrences all number
    39
    42
    Pyrexia
         subjects affected / exposed
    12 / 93 (12.90%)
    3 / 96 (3.13%)
         occurrences all number
    16
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    33 / 93 (35.48%)
    26 / 96 (27.08%)
         occurrences all number
    47
    64
    Constipation
         subjects affected / exposed
    13 / 93 (13.98%)
    17 / 96 (17.71%)
         occurrences all number
    16
    24
    Vomiting
         subjects affected / exposed
    14 / 93 (15.05%)
    15 / 96 (15.63%)
         occurrences all number
    24
    33
    Diarrhoea
         subjects affected / exposed
    11 / 93 (11.83%)
    17 / 96 (17.71%)
         occurrences all number
    19
    19
    Stomatitis
         subjects affected / exposed
    2 / 93 (2.15%)
    5 / 96 (5.21%)
         occurrences all number
    3
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 93 (13.98%)
    6 / 96 (6.25%)
         occurrences all number
    15
    9
    Dyspnoea
         subjects affected / exposed
    7 / 93 (7.53%)
    9 / 96 (9.38%)
         occurrences all number
    7
    11
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    8 / 93 (8.60%)
    15 / 96 (15.63%)
         occurrences all number
    10
    15
    Rash
         subjects affected / exposed
    4 / 93 (4.30%)
    12 / 96 (12.50%)
         occurrences all number
    4
    12
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 93 (5.38%)
    3 / 96 (3.13%)
         occurrences all number
    7
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 93 (5.38%)
    6 / 96 (6.25%)
         occurrences all number
    7
    13
    Pain in extremity
         subjects affected / exposed
    4 / 93 (4.30%)
    6 / 96 (6.25%)
         occurrences all number
    4
    6
    Bone pain
         subjects affected / exposed
    7 / 93 (7.53%)
    1 / 96 (1.04%)
         occurrences all number
    7
    1
    Spinal pain
         subjects affected / exposed
    5 / 93 (5.38%)
    0 / 96 (0.00%)
         occurrences all number
    5
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    10 / 93 (10.75%)
    9 / 96 (9.38%)
         occurrences all number
    10
    9
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 93 (9.68%)
    7 / 96 (7.29%)
         occurrences all number
    13
    8
    Urinary tract infection
         subjects affected / exposed
    3 / 93 (3.23%)
    5 / 96 (5.21%)
         occurrences all number
    3
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 93 (8.60%)
    10 / 96 (10.42%)
         occurrences all number
    10
    12
    Hypokalaemia
         subjects affected / exposed
    5 / 93 (5.38%)
    11 / 96 (11.46%)
         occurrences all number
    11
    16
    Hypomagnesaemia
         subjects affected / exposed
    4 / 93 (4.30%)
    6 / 96 (6.25%)
         occurrences all number
    4
    8
    Hyperglycaemia
         subjects affected / exposed
    4 / 93 (4.30%)
    5 / 96 (5.21%)
         occurrences all number
    9
    11
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 93 (1.08%)
    6 / 96 (6.25%)
         occurrences all number
    2
    6
    Hypocalcaemia
         subjects affected / exposed
    0 / 93 (0.00%)
    6 / 96 (6.25%)
         occurrences all number
    0
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jan 2021
    Amendment 2 v3.0 − Revised disease-free interval to ≥6 months and <12 months.
    02 Mar 2021
    Amendment 3 v4.0 − Updated language regarding regions to include China and account for regional differences in other countries such as in Eastern Europe, Russia, and China. − Updated Inclusion criterion to include language regarding red blood cell transfusion or erythropoiesis stimulating agent administration. − Changed gemcitabine/carboplatin dose calculation form “adjusted” to actual body weight. − Added language to Section 'Measures to Minimize Bias' to provide clarity on the definition of disease-free interval. − Added language to Section 'Definitions of Tumor Response and Disease Progression' to provide clarification for the use of PET scans in this study.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to change in treatment landscape for the second-line TNBC patients, planned analyses for Cohort 2 was not conducted and data of few selective efficacy parameters for Cohort 1 were collected and analyzed.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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