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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04799249
Registration number
NCT04799249
Ethics application status
Date submitted
18/02/2021
Date registered
16/03/2021
Date last updated
16/01/2024
Titles & IDs
Public title
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
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Scientific title
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)
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Secondary ID [1]
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2020-004930-39
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Secondary ID [2]
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G1T28-208
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Universal Trial Number (UTN)
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Trial acronym
PRESERVE 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
TNBC - Triple-Negative Breast Cancer
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Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Trilaciclib
Treatment: Drugs - Placebo
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin
Experimental: Trilaciclib + gemcitabine + carboplatin - Trilaciclib (240mg/m2) + gemcitabine (1000 mg/m2) and carboplatin (AUC 2)
Placebo Comparator: Placebo + gemcitabine + carboplatin - The subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib.
Treatment: Drugs: Trilaciclib
Trilaciclib administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
Treatment: Drugs: Placebo
Placebo administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
Treatment: Drugs: Gemcitabine
Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle.
Treatment: Drugs: Carboplatin
Carboplatin administered IV on Day 1 and Day 8 of each 21-day cycle.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Effect on Overall Survival (OS)
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Assessment method [1]
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(Cohort 1):To evaluate the effect of trilaciclib on overall survival (OS) compared with placebo in patients receiving first-line gemcitabine and carboplatin.
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Timepoint [1]
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Cohort 1:From date of randomization up to 39 months
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Primary outcome [2]
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Effect on Overall Survival (OS)
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Assessment method [2]
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(Cohort 2): To evaluate the effect of trilaciclib on OS compared with placebo in patients receiving gemcitabine and carboplatin as second-line therapy after treatment with a PD-1/PD-L1 inhibitor in the locally advanced unresectable/metastatic setting
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Timepoint [2]
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Cohort 2: From date of randomization up to 28 months
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Secondary outcome [1]
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Quality of life/Effects On Chemotherapy-Induced Fatigue
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Assessment method [1]
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To assess the effect of trilaciclib on patients' quality of life as measured by time to first confirmed deterioration of fatigue compared with placebo in patients receiving gemcitabine and carboplatin
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Timepoint [1]
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Cycle 1 Day 1 (each cycle is 21 days) up to 14 months
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Secondary outcome [2]
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Myeloprotective Effects
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Assessment method [2]
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Occurrence of cytopenias, febrile neutropenia, hospitalization due to chemotherapy-induced myelosuppression, RBC and platelet transfusions, growth factor administration, and dose reductions and delays
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Timepoint [2]
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Cycle 1 Day 1 (each cycle is 21 days) up to 14 months
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Secondary outcome [3]
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Progression Free Survival
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Assessment method [3]
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To evaluate the effect of trilaciclib on progression-free survival (PFS) compared with placebo in patients receiving gemcitabine and carboplatin.
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Timepoint [3]
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From date of randomization up to 14 months)
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Eligibility
Key inclusion criteria
1. Age >/= 18 years of age with evaluable locally advanced unresectable or metastatic
TNBC.
2. Documentation of triple negative breast cancer (estrogen and progesterone receptor <1%
and HER2-negative)
3. Prior systemic therapies (Cohort 1 only):
1. No prior systemic therapy in the locally advanced unresectable/metastatic setting
including chemotherapy, targeted therapy, immunotherapy, or investigational
agents.
2. Prior PD-1/PD-L1 inhibitor treatment is not permitted in any setting, including
in the neoadjuvant setting.
3. Time between completion of last treatment with curative intent and first
metastatic recurrence must be = 6 months.
4. Prior systemic therapies (Cohort 2 only):
1. Documentation of PD-L1 positive status
2. Treated with a PD-1/PD-L1 inhibitor for a minimum duration of 4 months in the
locally advanced unresectable/metastatic setting and as the most recent therapy.
5. Radiation therapy for metastatic disease is permitted. There is no required minimum
washout period for radiation therapy. Patients should be recovered from the effects of
radiation.
6. Archival tumor tissue must be available or a fresh biopsy must be obtained, unless
approved by the Medical Monitor.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Adequate organ function as demonstrated by normal laboratory values
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior treatment with gemcitabine in any setting.
2. Prior treatment with carboplatin in the locally advanced unresectable/metastatic
setting.
Prior carboplatin in the (neo)adjuvant/curative setting is permitted as long as it was
completed = 6 months prior to the first metastatic recurrence.
3. Presence of central nervous system (CNS) metastases and/or leptomeningeal disease
requiring immediate treatment with radiation therapy or steroids.
4. Receipt of any cytotoxic chemotherapy within 14 days prior to the first dose of study
drugs.
5. QTcF interval >480 msec at Screening (confirmed in triplicate). For patients with
ventricular pacemakers, QTcF >500 msec.
6. Known hypersensitivity to carboplatin or other platinum-containing compounds, or
mannitol
7. Pregnant or lactating women
8. Prior hematopoietic stem cell or bone marrow transplantation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/10/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
194
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre - Oncology - East Melbourne
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Cabrini Health - Malvern
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Recruitment hospital [5]
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Mater Hospital Sydney - North Sydney
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4575 - Birtinya
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Recruitment postcode(s) [3]
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08006 - East Melbourne
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Recruitment postcode(s) [4]
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3144 - Malvern
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Recruitment postcode(s) [5]
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2060 - North Sydney
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Recruitment outside Australia
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United States of America
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Arizona
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District of Columbia
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Florida
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Sofia
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Beijing
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China
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Chongqing
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China
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Jilin
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Caen
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Dnipro
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
G1 Therapeutics, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating
the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and
carboplatin in patients receiving first- or second-line treatment for locally advanced
unresectable/metastatic TNBC.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04799249
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Contact
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Address
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G1 Therapeutics, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04799249
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