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TNBC - Triple-Negative Breast CancerPhase 3PRESERVE 2NCT04799249

Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

A Phase 3 study testing Trilaciclib, Gemcitabine and Carboplatin in people with TNBC - Triple-Negative Breast Cancer and Breast Cancer, run by G1 Therapeutics, Inc. at 71 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trilaciclib, Gemcitabine and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
194 participants
Where
71 sitesin 11 countries
Study dates
14 May 2021to 24 May 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >/= 18 years of age with evaluable locally advanced unresectable or metastatic TNBC.
  • Documentation of triple negative breast cancer (estrogen and progesterone receptor <1% and HER2-negative)
  • Prior systemic therapies (Cohort 1 only):
  • No prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, targeted therapy, immunotherapy, or investigational agents.
  • Prior PD-1/PD-L1 inhibitor treatment is not permitted in any setting, including in the neoadjuvant setting.
  • Time between completion of last treatment with curative intent and first metastatic recurrence must be ≥ 6 months.
Show all 13Show fewer
  • Prior systemic therapies (Cohort 2 only):
  • Documentation of PD-L1 positive status
  • 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.
  • 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.
  • Archival tumor tissue must be available or a fresh biopsy must be obtained, unless approved by the Medical Monitor.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function as demonstrated by normal laboratory values

Who cannot join

  • Prior treatment with gemcitabine in any setting.
  • 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.
  • Presence of central nervous system (CNS) metastases and/or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids.
  • Receipt of any cytotoxic chemotherapy within 14 days prior to the first dose of study drugs.
  • QTcF interval >480 msec at Screening (confirmed in triplicate). For patients with ventricular pacemakers, QTcF >500 msec.
Show all 9Show fewer
  • Known hypersensitivity to carboplatin or other platinum-containing compounds, or mannitol
  • Pregnant or lactating women
  • Prior hematopoietic stem cell or bone marrow transplantation

Trial locations and contacts

71 sites in 11 countries.

71 sites in 11 countries

United States16 sites

  • Texas Oncology- Austin Central

    Austin, Texas, 78731

  • Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • Maryland Oncology Hematology, P.A.

    Clinton, Maryland, 20735

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • Banner M.D. Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Saint Luke's Cancer Specialists

    Kansas City, Missouri, 64111

  • Comprehensive Cancer Genetics of Nevada

    Las Vegas, Nevada, 89128

  • Baptist Cancer Cancer - Oncology

    Memphis, Tennessee, 38120

  • Tennessee Oncology (SCRI)

    Nashville, Tennessee, 37203

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • UPC Pinnacle Health Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Florida Cancer Specialists - North (SCRI)

    St. Petersburg, Florida, 33705

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Texas Oncology P.A.

    Tyler, Texas, 75702

  • Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research

    Washington D.C., District of Columbia, 20010

Other trials in United States

China11 sites

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Cancer Hospital Chinese Academy of Medical Sciences

    Chaoyang, Beijing Municipality, 100021

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Anhui Provincial Hospital

    Harbin, Heilongjiang, 150081

  • Fudan University Shanghai Cancer Center

    Shanghai, 450052

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • Sun Yat-sen University Cancer Center

    Yuexiucun, Guangzhou, 510060

  • The First Affiliated Hospital of Chongqing Medical University

    Yuzhong, Chongqing Municipality, 401122

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Georgia7 sites

  • High Technology Hospital MedCenter LTD

    Batumi, Adjara, 6010

  • Acad.Fridon Todua Medical Center - Research Institute of Clinical Medicine

    Tbilisi, 0112

  • ARENSIA Exploratory Medicine Harmony Health

    Tbilisi, 0112

  • LTD Israeli-Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112

  • LTD Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186

  • TIM - Tbilisi Institute of Medicine LTD

    Tbilisi, 0186

  • Institute Of Clinical Oncology LTD

    Tbilisi, 159

Other trials in Georgia

Spain7 sites

  • Hospital Universitario de Badajos

    Badajoz, 06006

  • Hospital Universitario 12 de Octubre

    Barcelona, 08035

  • Vall d'Hebrón University Hospital

    Barcelona, 08035

  • Hospital Clìnic de Barcelona

    Barcelona, 08036

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Puerta de Hierro Majadahonda

    Madrid, Majadahonda, 28222

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

Other trials in Spain

France6 sites

  • Centre Francois Baclesse

    Caen, 14000

  • Centre Jean Bernard

    Le Mans, Europe, 72000

  • ICM-Val d'Aurelle

    Montpellier, 34298

  • Centre Hospitalier de Poitiers

    Poitiers, 86000

  • Pharmacie Essais Cliniques

    Toulouse, 31100

  • Centre Leon Berard

    Villejuif, 94800

Other trials in France

Poland6 sites

  • Pratia MCM Krakow

    Krakow, Lesser Poland Voivodeship, 30-510

  • Instytut MSF Sp. z. o.o.

    Lodz, 90-302

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Chorob Rozrostowych

    Lodz, 93-513

  • Med-Polonia Sp. Z o.o.

    Poznan, Greater Poland Voivodeship, 60-569

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej - Curie - Panstwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

Australia5 sites

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Peter MacCallum Cancer Centre - Oncology

    East Melbourne, Victoria, 08006

  • Cabrini Health

    Malvern, Victoria, 3144

  • Mater Hospital Sydney

    North Sydney, 2060

Other trials in Australia

Russia5 sites

  • SAHI Republcx Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republix

    Kazan', 420029

  • Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Dispensary"

    Moscow, Balashikha, 143900

  • FSBI Russian Scientific Center of Roentgenoradiology of the MoH of Russia

    Moscow, 117997

  • State Budgetary Healthcare Institution of Moscow Region "Moscow Reginoal Oncology Dispensary"

    Moscow, 143900

  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"

    Omsk, 644013

Other trials in Russia

Ukraine5 sites

  • Komunalne nekomertsiine pidpryiemstvo Miska klinichna likarnia No 4 Dniprovskoi miskoi rady

    Dnipro, 49102

  • Yuri Prokopovich Spizhenko

    Kapitanivka, Kyivska Oblast, 08112

  • Volynskyi oblasnyi medychnyi tsentr onkolohii

    Lutsk, Volyn Oblast, 63000

  • Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady Sumskyi oblasnyi onkolohichnyi dyspanser

    Sumy, Sumska Oblast, 40022

  • Komunalne nekomertsiine pidpryiemstvo Ternopilskyi oblasnyi klinichnyi onkolohichnyi dyspanser Ternopilskoi oblasnoi rady

    Ternopil, Ternopil Oblast, 46023

Other trials in Ukraine

Bulgaria2 sites

  • Complex Oncology Center - Burgas

    Burgas, 8000

  • Medical Ctr Nadezhda Clinical

    Sofia, 1330

Other trials in Bulgaria

Moldova1 site

  • IMSP Institutul Oncologic, ARENSIA Exploratory Medicine

    Chisinau, MD-2025

Other trials in Moldova

About this study

Official 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)

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.

Read the detailed description

This study will have two separate cohorts (Cohort 1 and Cohort 2). Both cohorts will follow the same general study conduct/design with similar primary and key secondary endpoints and identical treatment arms.

  • Cohort 1 will evaluate patients receiving first-line therapy, regardless of programmed death-ligand 1 (PD-L1) status, who are programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy naïve.
  • Cohort 2 will evaluate PD-L1 positive patients receiving second-line therapy following prior PD-1/PD-L1 inhibitor therapy in the locally advanced unresectable/metastatic setting.
Being tested
Trilaciclib, Placebo, Gemcitabine, Carboplatin
Keywords
breast cancer, gemcitabine, carboplatin, solid tumors, breast, chemotherapy, TNBC, trilaciclib, cyclin-dependent kinase 4/6 inhibitor, CDK 4/6 Inhibitor, triple-negative breast cancer, metastatic, chemotherapy-induced fatigue, HER2-negative, immunotherapy, immune checkpoint inhibitor therapy, chemotherapy-induced myelosuppression, myeloprotection, myeloprotective, PD-1/PD-L1 inhibitor therapy
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrilaciclibDrug

    Also called G1T28, COSELA

    Trilaciclib administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.

  • PlaceboDrug

    Also called 0.9% normal saline, 5 % Dextrose in water (D5W)

    Placebo administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.

  • GemcitabineDrug

    Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle.

  • CarboplatinDrug

    Carboplatin administered IV on Day 1 and Day 8 of each 21-day cycle.

Study groups in NCT04799249
Study groupRoleWhat they receive
Trilaciclib + gemcitabine + carboplatinExperimentalTrilaciclib (240mg/m2) + gemcitabine (1000 mg/m2) and carboplatin (AUC 2)
Receives: Drug: Trilaciclib; Drug: Gemcitabine; Drug: Carboplatin
Placebo + gemcitabine + carboplatinPlacebo comparatorThe subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib.
Receives: Drug: Placebo; Drug: Gemcitabine; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect on Overall Survival (OS)

    (Cohort 1):To evaluate the effect of trilaciclib on overall survival (OS) compared with placebo in patients receiving first-line gemcitabine and carboplatin.

    Measured: Cohort 1:From date of randomization up to 39 months

  2. Effect on Overall Survival (OS)

    (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

    Measured: Cohort 2: From date of randomization up to 28 months

Secondary outcomes (3)

  1. Quality of life/Effects On Chemotherapy-Induced Fatigue

    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

    Measured: Cycle 1 Day 1 (each cycle is 21 days) up to 14 months

  2. Myeloprotective Effects

    Occurrence of cytopenias, febrile neutropenia, hospitalization due to chemotherapy-induced myelosuppression, RBC and platelet transfusions, growth factor administration, and dose reductions and delays

    Measured: Cycle 1 Day 1 (each cycle is 21 days) up to 14 months

  3. Progression Free Survival

    To evaluate the effect of trilaciclib on progression-free survival (PFS) compared with placebo in patients receiving gemcitabine and carboplatin.

    Measured: From date of randomization up to 14 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start14 May 2021
  3. Primary completion24 May 2024
  4. Study completion24 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04799249
Sponsor's protocol ID
G1T28-208
Other IDs
2020-004930-39
Acronym
PRESERVE 2
Status last verified
Jul 2024
First submitted
18 Feb 2021
Last updated
1 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 36135712

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trilaciclib, Gemcitabine and Carboplatin in people with TNBC - Triple-Negative Breast Cancer and Breast Cancer, run by G1 Therapeutics, Inc. at 71 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, China, Georgia, Spain, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on Overall Survival (OS) (time frame: Cohort 1:From date of randomization up to 39 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04799249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.

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