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

PHASE3CompletedINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

May 14, 2021

Primary Completion Date

May 24, 2024

Study Completion Date

May 24, 2024

Conditions
TNBC - Triple-Negative Breast CancerBreast Cancer
Interventions
DRUG

Trilaciclib

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

DRUG

Placebo

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

DRUG

Gemcitabine

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

DRUG

Carboplatin

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

Trial Locations (71)

159

Institute Of Clinical Oncology LTD, Tbilisi

1330

Medical Ctr Nadezhda Clinical, Sofia

2050

Chris O'Brien Lifehouse, Camperdown

2060

Mater Hospital Sydney, North Sydney

3144

Cabrini Health, Malvern

4575

Sunshine Coast University Hospital, Birtinya

6010

High Technology Hospital MedCenter LTD, Batumi

8000

Complex Oncology Center - Burgas, Burgas

14000

Centre Francois Baclesse, Caen

15232

UPC Pinnacle Health Cancer Institute, Pittsburgh

20010

Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research, Washington D.C.

20735

Maryland Oncology Hematology, P.A., Clinton

23502

Virginia Oncology Associates, Norfolk

27710

Duke Cancer Center, Durham

28034

Hospital Universitario Ramón y Cajal, Madrid

28222

Hospital Puerta de Hierro Majadahonda, Madrid

31100

Pharmacie Essais Cliniques, Toulouse

33612

Moffitt Cancer Center, Tampa

33705

Florida Cancer Specialists - North (SCRI), St. Petersburg

34298

ICM-Val d'Aurelle, Montpellier

37203

Tennessee Oncology (SCRI), Nashville

37404

Tennessee Oncology Chattanooga, Chattanooga

38120

Baptist Cancer Cancer - Oncology, Memphis

40022

Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady Sumskyi oblasnyi onkolohichnyi dyspanser, Sumy

46023

Komunalne nekomertsiine pidpryiemstvo Ternopilskyi oblasnyi klinichnyi onkolohichnyi dyspanser Ternopilskoi oblasnoi rady, Ternopil

49102

Komunalne nekomertsiine pidpryiemstvo Miska klinichna likarnia No 4 Dniprovskoi miskoi rady, Dnipro

63000

Volynskyi oblasnyi medychnyi tsentr onkolohii, Lutsk

64111

Saint Luke's Cancer Specialists, Kansas City

72000

Centre Jean Bernard, Le Mans

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

75702

Texas Oncology P.A., Tyler

78731

Texas Oncology- Austin Central, Austin

85234

Banner M.D. Anderson Cancer Center, Gilbert

86000

Centre Hospitalier de Poitiers, Poitiers

89128

Comprehensive Cancer Genetics of Nevada, Las Vegas

94800

Centre Leon Berard, Villejuif

100021

Cancer Hospital Chinese Academy of Medical Sciences, Chaoyang

117997

FSBI Russian Scientific Center of Roentgenoradiology of the MoH of Russia, Moscow

130021

Jilin Cancer Hospital, Changchun

The First Hospital of Jilin University, Changchun

143900

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

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

150081

Anhui Provincial Hospital, Harbin

300060

Tianjin Cancer Hospital, Tianjin

310022

Zhejiang Cancer Hospital, Hangzhou

401122

The First Affiliated Hospital of Chongqing Medical University, Yuzhong

420029

SAHI Republcx Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republix, Kazan'

450052

First Affiliated Hospital of Zhengzhou University, Zhengzhou

Fudan University Shanghai Cancer Center, Shanghai

510060

Sun Yat-sen University Cancer Center, Yuexiucun

644013

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

08006

Peter MacCallum Cancer Centre - Oncology, East Melbourne

050011

The Fourth Hospital of Hebei Medical University, Shijiazhuang

0112

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

ARENSIA Exploratory Medicine Harmony Health, Tbilisi

LTD Israeli-Georgian Medical Research Clinic Helsicore, Tbilisi

0186

LTD Multiprofile Clinic Consilium Medulla, Tbilisi

TIM - Tbilisi Institute of Medicine LTD, Tbilisi

MD-2025

IMSP Institutul Oncologic, ARENSIA Exploratory Medicine, Chisinau

60-569

Med-Polonia Sp. Z o.o., Poznan

30-510

Pratia MCM Krakow, Krakow

90-302

Instytut MSF Sp. z. o.o., Lodz

93-513

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

60-185

Centrum Medyczne Pratia Poznan, Skorzewo

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej - Curie - Panstwowy Instytut Badawczy, Warsaw

03203

Hospital General Universitario de Elche, Elche

06006

Hospital Universitario de Badajos, Badajoz

08035

Hospital Universitario 12 de Octubre, Barcelona

Vall d'Hebrón University Hospital, Barcelona

08036

Hospital Clìnic de Barcelona, Barcelona

08112

Yuri Prokopovich Spizhenko, Kapitanivka

Sponsors
All Listed Sponsors
lead

G1 Therapeutics, Inc.

INDUSTRY

NCT04799249 - Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC) | Biotech Hunter | Biotech Hunter