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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04799249




Registration number
NCT04799249
Ethics application status
Date submitted
18/02/2021
Date registered
16/03/2021
Date last updated
1/08/2024

Titles & IDs
Public title
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
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)
Secondary ID [1] 0 0
2020-004930-39
Secondary ID [2] 0 0
G1T28-208
Universal Trial Number (UTN)
Trial acronym
PRESERVE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
TNBC - Triple-Negative Breast Cancer 0 0
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effect on Overall Survival (OS)
Timepoint [1] 0 0
Cohort 1:From date of randomization up to 39 months
Primary outcome [2] 0 0
Effect on Overall Survival (OS)
Timepoint [2] 0 0
Cohort 2: From date of randomization up to 28 months
Secondary outcome [1] 0 0
Quality of life/Effects On Chemotherapy-Induced Fatigue
Timepoint [1] 0 0
Cycle 1 Day 1 (each cycle is 21 days) up to 14 months
Secondary outcome [2] 0 0
Myeloprotective Effects
Timepoint [2] 0 0
Cycle 1 Day 1 (each cycle is 21 days) up to 14 months
Secondary outcome [3] 0 0
Progression Free Survival
Timepoint [3] 0 0
From date of randomization up to 14 months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/05/2024
Sample size
Target
Accrual to date
Final
194
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Oncology - East Melbourne
Recruitment hospital [4] 0 0
Cabrini Health - Malvern
Recruitment hospital [5] 0 0
Mater Hospital Sydney - North Sydney
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
08006 - East Melbourne
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
2060 - North Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Burgas
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Sofia
Country [14] 0 0
China
State/province [14] 0 0
Beijing
Country [15] 0 0
China
State/province [15] 0 0
Chongqing
Country [16] 0 0
China
State/province [16] 0 0
Guangzhou
Country [17] 0 0
China
State/province [17] 0 0
Hebei
Country [18] 0 0
China
State/province [18] 0 0
Heilongjiang
Country [19] 0 0
China
State/province [19] 0 0
Henan
Country [20] 0 0
China
State/province [20] 0 0
Jilin
Country [21] 0 0
China
State/province [21] 0 0
Tianjin
Country [22] 0 0
China
State/province [22] 0 0
Zhejiang
Country [23] 0 0
China
State/province [23] 0 0
Shanghai
Country [24] 0 0
France
State/province [24] 0 0
Europe
Country [25] 0 0
France
State/province [25] 0 0
Caen
Country [26] 0 0
France
State/province [26] 0 0
Montpellier
Country [27] 0 0
France
State/province [27] 0 0
Poitiers
Country [28] 0 0
France
State/province [28] 0 0
Toulouse
Country [29] 0 0
France
State/province [29] 0 0
Villejuif
Country [30] 0 0
Georgia
State/province [30] 0 0
Ajaria
Country [31] 0 0
Georgia
State/province [31] 0 0
Tbilisi
Country [32] 0 0
Moldova, Republic of
State/province [32] 0 0
Chisinau
Country [33] 0 0
Poland
State/province [33] 0 0
Malopolskie
Country [34] 0 0
Poland
State/province [34] 0 0
Wielkopolskie
Country [35] 0 0
Poland
State/province [35] 0 0
Lodz
Country [36] 0 0
Poland
State/province [36] 0 0
Skorzewo
Country [37] 0 0
Poland
State/province [37] 0 0
Warszawa
Country [38] 0 0
Poland
State/province [38] 0 0
Lódz
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Balashikha
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Kazan
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Moscow
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Omsk
Country [43] 0 0
Spain
State/province [43] 0 0
Alicante
Country [44] 0 0
Spain
State/province [44] 0 0
Majadahonda
Country [45] 0 0
Spain
State/province [45] 0 0
Badajoz
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Ukraine
State/province [48] 0 0
Kyivska Oblast
Country [49] 0 0
Ukraine
State/province [49] 0 0
Sums'ka Oblast
Country [50] 0 0
Ukraine
State/province [50] 0 0
Ternopil's'ka Oblast
Country [51] 0 0
Ukraine
State/province [51] 0 0
Volyns'ka Oblast
Country [52] 0 0
Ukraine
State/province [52] 0 0
Dnipro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
G1 Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04799249
Trial related presentations / publications
Goel S, Tan AR, Rugo HS, Aftimos P, Andric Z, Beelen A, Zhang J, Yi JS, Malik R, O'Shaughnessy J. Trilaciclib prior to gemcitabine plus carboplatin for metastatic triple-negative breast cancer: phase III PRESERVE 2. Future Oncol. 2022 Oct;18(33):3701-3711. doi: 10.2217/fon-2022-0773. Epub 2022 Sep 22.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Contact
Address 0 0
G1 Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04799249