Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
NCT ID: NCT04799249
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
194 participants
INTERVENTIONAL
2021-05-14
2024-05-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
NCT02978716
Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer
NCT05112536
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
NCT05113966
Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-Negative Breast Cancer
NCT01964924
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
NCT01881230
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Trilaciclib + gemcitabine + carboplatin
Trilaciclib (240mg/m2) + gemcitabine (1000 mg/m2) and carboplatin (AUC 2)
Trilaciclib
Trilaciclib administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
Gemcitabine
Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle.
Carboplatin
Carboplatin administered IV on Day 1 and Day 8 of each 21-day cycle.
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.
Placebo
Placebo administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
Gemcitabine
Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle.
Carboplatin
Carboplatin administered IV on Day 1 and Day 8 of each 21-day cycle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Trilaciclib
Trilaciclib administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
Placebo
Placebo administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
Gemcitabine
Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle.
Carboplatin
Carboplatin administered IV on Day 1 and Day 8 of each 21-day cycle.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
G1 Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Contact
Role: STUDY_DIRECTOR
G1 Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Banner M.D. Anderson Cancer Center
Gilbert, Arizona, United States
Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research
Washington D.C., District of Columbia, United States
Florida Cancer Specialists - North (SCRI)
St. Petersburg, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Maryland Oncology Hematology, P.A.
Clinton, Maryland, United States
Saint Luke's Cancer Specialists
Kansas City, Missouri, United States
Comprehensive Cancer Genetics of Nevada
Las Vegas, Nevada, United States
Duke Cancer Center
Durham, North Carolina, United States
UPC Pinnacle Health Cancer Institute
Pittsburgh, Pennsylvania, United States
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Baptist Cancer Cancer - Oncology
Memphis, Tennessee, United States
Tennessee Oncology (SCRI)
Nashville, Tennessee, United States
Texas Oncology- Austin Central
Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology P.A.
Tyler, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Peter MacCallum Cancer Centre - Oncology
East Melbourne, Victoria, Australia
Cabrini Health
Malvern, Victoria, Australia
Mater Hospital Sydney
North Sydney, , Australia
Complex Oncology Center - Burgas
Burgas, , Bulgaria
Medical Ctr Nadezhda Clinical
Sofia, , Bulgaria
Cancer Hospital Chinese Academy of Medical Sciences
Chaoyang, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Yuzhong, Chongqing Municipality, China
Sun Yat-sen University Cancer Center
Yuexiucun, Guangzhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Anhui Provincial Hospital
Harbin, Heilongjiang, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Fudan University Shanghai Cancer Center
Shanghai, , China
Centre Jean Bernard
Le Mans, Europe, France
Centre Francois Baclesse
Caen, , France
ICM-Val d'Aurelle
Montpellier, , France
Centre Hospitalier de Poitiers
Poitiers, , France
Pharmacie Essais Cliniques
Toulouse, , France
Centre Leon Berard
Villejuif, , France
High Technology Hospital MedCenter LTD
Batumi, Adjara, Georgia
Acad.Fridon Todua Medical Center - Research Institute of Clinical Medicine
Tbilisi, , Georgia
ARENSIA Exploratory Medicine Harmony Health
Tbilisi, , Georgia
LTD Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
LTD Multiprofile Clinic Consilium Medulla
Tbilisi, , Georgia
TIM - Tbilisi Institute of Medicine LTD
Tbilisi, , Georgia
Institute Of Clinical Oncology LTD
Tbilisi, , Georgia
IMSP Institutul Oncologic, ARENSIA Exploratory Medicine
Chisinau, , Moldova
Med-Polonia Sp. Z o.o.
Poznan, Greater Poland Voivodeship, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, Poland
Instytut MSF Sp. z. o.o.
Lodz, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Chorob Rozrostowych
Lodz, , Poland
Centrum Medyczne Pratia Poznan
Skorzewo, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej - Curie - Panstwowy Instytut Badawczy
Warsaw, , Poland
Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Dispensary"
Moscow, Balashikha, Russia
SAHI Republcx Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republix
Kazan', , Russia
FSBI Russian Scientific Center of Roentgenoradiology of the MoH of Russia
Moscow, , Russia
State Budgetary Healthcare Institution of Moscow Region "Moscow Reginoal Oncology Dispensary"
Moscow, , Russia
Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"
Omsk, , Russia
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Puerta de Hierro Majadahonda
Madrid, Majadahonda, Spain
Hospital Universitario de Badajos
Badajoz, , Spain
Hospital Universitario 12 de Octubre
Barcelona, , Spain
Vall d'Hebrón University Hospital
Barcelona, , Spain
Hospital Clìnic de Barcelona
Barcelona, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Yuri Prokopovich Spizhenko
Kapitanivka, Kyivska Oblast, Ukraine
Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady Sumskyi oblasnyi onkolohichnyi dyspanser
Sumy, Sumska Oblast, Ukraine
Komunalne nekomertsiine pidpryiemstvo Ternopilskyi oblasnyi klinichnyi onkolohichnyi dyspanser Ternopilskoi oblasnoi rady
Ternopil, Ternopil Oblast, Ukraine
Volynskyi oblasnyi medychnyi tsentr onkolohii
Lutsk, Volyn Oblast, Ukraine
Komunalne nekomertsiine pidpryiemstvo Miska klinichna likarnia No 4 Dniprovskoi miskoi rady
Dnipro, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-004930-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
G1T28-208
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.