Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC) (PRESERVE 2)
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研究单位：[1]G1 Therapeutics, Inc.[2]Ironwood Cancer and Research Centers Chandler, Arizona, United States, 85224[3]3236-Banner M.D. Anderson Cancer Center Gilbert, Arizona, United States, 85234[4]Sansum Clinic Santa Barbara, California, United States, 93105[5]Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research Washington, District of Columbia, United States, 20010[6]Florida Cancer Specialists - North (SCRI) Saint Petersburg, Florida, United States, 33705[7]Moffitt Cancer Center Tampa, Florida, United States, 33612[8]Illinois Cancer Specialists Niles, Illinois, United States, 60005[9]University of Maryland Greenbaum Comprehensive Cancer Ctr-site# 1128 Baltimore, Maryland, United States, 21021[10]Maryland Oncology Hematology, P.A. Clinton, Maryland, United States, 20735[11]Saint Luke's Cancer Specialists Kansas City, Missouri, United States, 64111[12]Comprehensive Cancer Genetics of Nevada Las Vegas, Nevada, United States, 89128[13]Atrium Health Levine Cancer Institute Charlotte, North Carolina, United States, 28204[14]3312-Duke Cancer Center Durham, North Carolina, United States, 27710[15]Northwest Cancer Specialists, PC Portland, Oregon, United States, 97225[16]UPC Pinnacle Health Cancer Institute Pittsburgh, Pennsylvania, United States, 15232[17]Abington Hematology Oncology Willow Grove, Pennsylvania, United States, 19090[18]Tennessee Oncology Chattanooga Chattanooga, Tennessee, United States, 37404[19]Baptist Cancer Cancer - Oncology Memphis, Tennessee, United States, 38120[20]Tennessee Oncology (SCRI) Nashville, Tennessee, United States, 37203[21]Texas Oncology- Austin Central Austin, Texas, United States, 78731[22]Texas Oncology P.A. Dallas, Texas, United States, 75231[23]Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas, Texas, United States, 75246[24]Texas Oncology-West Texas El Paso, Texas, United States, 79912[25]Texas Oncology - Houston Memorial City Houston, Texas, United States, 77024[26]Texas Oncology P.A. Houston, Texas, United States, 77070[27]Texas Oncology Cancer Care and Research Center (site# 3317) Irving, Texas, United States, 75063[28]Texas Oncology P.A. Tyler, Texas, United States, 75702[29]Virginia Cancer Specialists, PC Fairfax, Virginia, United States, 22031[30]Virginia Oncology Associates Norfolk, Virginia, United States, 23502[31](3151) 119-143 Missenden Road Camperdown, New South Wales, Australia, 2050[32]3138-Sunshine Coast University Hospital Birtinya, Queensland, Australia, 4575[33]3102-Peter MacCallum Cancer Centre - Oncology East Melbourne, Victoria, Australia, 08006[34]3150-Cabrini Malvern , Hospital Malvern, Victoria, Australia, 3144[35]3152 Mater Hospital Sydney North Sydney, Australia, 2060[36]1239-Complex Oncology Center - Burgas Burgas, Bulgaria, 8000[37]1320-Mhat Dr.Tota Venkova Gabrovo, Bulgaria, 5300[38]1315-Medical Ctr Nadezhda Clinical Sofia, Bulgaria, 1330[39]1258- Acibadem City Clinic Tokuda Sofia, Bulgaria, 1407[40]3269-Anhui Provincial Hospital Hefei, Anhui, China, 230001[41]3266--Cancer Hospital Chinese Academy of Medical Sciences Chaoyang, Beijing, China, 100021[42]3274---The First Affiliated Hospital of Chongqing Medical University Yuzhong, Chongqing, China, 401122[43]3275-Sun Yat-sen University Cancer Center Yuexiu, Guangzhou, China, 510060[44]3272-The Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China, 050011河北医科大学第四医院[45]3267__Harbin Medical University Cancer Hospital Harbin, Heilongjiang, China, 150081[46]3205-First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan, China, 450052[47]3268---Jiangsu Maternal Child Health Nanjing, Jiangsu, China, 210000[48]3270-- The First Hospital of Jilin University Changchun, Jilin, China, 130021[49]3276--Jilin Cancer Hospital Changchun, Jilin, China, 130021[50]3271---Tianjin Cancer Hospital Tianjin, Tianjin, China, 300060[51]3273--Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310022[52]3339---No.270 Dong An Road Shanghai, China, 450052[53]3124-Centre Francois Baclesse Caen, Europe, France, 14000[54]3123-Centre Jean Bernard Le Mans, Europe, France, 72000[55]3118-Centre Hospitalier de Poitiers Poitiers, Europe, France, 86000[56]3125-Centre Leon Berard Villejuif, Europe, France, 94800[57]3119-31 rue de la Croix Verte , ICM-Val d'Aurelle Montpellier, France, 34298[58]3120--Serv Pharmacie Recherche Clin Nantes, France, 44000[59]3122-Pharmacie Essais Cliniques Toulouse, France, 31100[60]3113-LTD"Brothers" Batumi, Ajaria, Georgia, 6010'[61]2822-"High Technology Hospital MedCenter" LTD Batumi, Ajaria, Georgia, 6010[62]1107-ARENSIA Exploratory Medicine Harmony Health Tbilisi, Georgia, 0112[63]3126-Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine Tbilisi, Georgia, 0112[64]3127- LTDIsraeli-Georgian Medical Research Clinic Helsicore Tbilisi, Georgia, 0112[65]3362-"Pineo Medical Ecosystem"LTD Tbilisi, Georgia, 0114[66]1255-Ljubljana Str "Tbilisi Cancer Center" LTD Tbilisi, Georgia, 0159[67]3337-LTD S.Khechinashvili University Hospital Tbilisi, Georgia, 0179[68]1256-Institute for Personalized Medicine LTD (site #-1256) Tbilisi, Georgia, 0186[69]3111-Consilium Medulla , Multiprofile Clinic Tbilisi, Georgia, 0186[70]3363-"TIM - Tbilisi Institute of Medicine" LTD Tbilisi, Georgia, 0186[71]3112-LTD "Institute Of Clinical Oncology" Tbilisi, Georgia, 159[72]1310_IMSP Institutul Oncologic, ARENSIA Exploratory Medicine Chisinau, Moldova, Republic of, MD-2025[73]3146-Pratia MCM Krakow Krakow, Malopolskie, Poland, 30-510[74]1314-MED-POLONIA Sp.z o.o. Poznan, Wielkopolskie, Poland, 60-569[75]3147-M.Kopernika.w.Lodzi Lodz, Poland, 93-513[76]2709-Centrum Medyczne Pratia Poznan Skorzewo, Poland, 60-185[77]3149 NarodowyInstytutiiMariiCurie Warszawa, Poland, 02-781[78]3354-Wojewodzki Szpital Specjali. , Wroclawiu Apteka Szpitalna , ul. H. M. Kamienskiego 73a Wroclaw, Poland, 51-124[79]1311-Instytut MSF Sp. z. o.o. Łódź, Poland, 90-302[80]3133-City Clinical Oncology Dispensary Moscow, Balashikha, Russian Federation, 143900[81]3116-Moscow City Oncology Hospital #62 Moscow, Krasnogorsk, Russian Federation, 143423[82]3132-Leningrad Regional Clinical Oncology Dispensary Moscow, Vsevolozhsky, Russian Federation, 188663[83]3114- Rep Clinical Onco. Disp. Mini Kazan, Russian Federation, 420029[84]3166-FSBI Ru.Sci Roentgenoradiol. Moscow, Russian Federation, 117997[85]3135-University Clinic of Headaches Moscow, Russian Federation, 121467[86]3134-Moscow Regional Oncology Dispensary Moscow, Russian Federation, 143900[87]3115-Mikhail Dvorkin, MD Omsk, Russian Federation, 644013[88]3136--LLC Clinic "Luch" Saint-Petersburg,, Russian Federation, 197110[89]1153-Clinical Hospital Center "Bezanijska Kosa", Oncology Clinic Belgrade, Serbia, 11000[90]1171-Special hospital for Internal diseases Oncomed system, Karposeva 91, Belgrade, Serbia, 11000[91]3101-Institute for Oncology and Radiology of Serbia Belgrade, Serbia, 11000[92]1155-University Clinical Center Nis, Oncology Clinic Nis, Serbia, 18000[93]1156- Oncology Institute of Vojvodina, Clinic for internal oncology Sremska Kamenica, Serbia, 21204[94]3139---H.G.U. de Elche Elche, Alicante, Spain, 03203[95]3154----Hospital Universitario Virgen del Rocío Avenida Manuel Siurot s/n Sevilla, Andalucía, Spain, 41013[96]3343-Hospital Puerta de Hierro Madrid, Majadahonda, Spain, 28222[97]3342-Hospit.Universit.Infanta, Cristina Servicio Farmacia Planta Badajoz, Spain, 06006[98]3142__Hospital Univ Vall d'Hebrón Barcelona, Spain, 08035[99]3144__Hospital Universitario 12 de Octubre Barcelona, Spain, 08035[100]3141---Hospital Clìnic de Barcelona Barcelona, Spain, 08036[101]3143--Hospital Universitari General de Catalunya Servicio de Oncologia Barcelona, Spain, 08190[102]3155__Hospital Univ Ramón y Cajal Madrid, Spain, 28034[103]3347-Hospital Universitari Son Palma de Mallorca, Spain, 07120[104]3140--Hosp Virgen de la Macarena Sevilla, Spain, 41009[105]2807--Dniprovske shose Kryvyi Rih, Dnipropetrovska, Ukraine, 50048[106]2808--ARENSIA Exploratory Medicine Kapitanivka, Kyivska Oblast, Ukraine, 08112[107]1251---Sumskyi obl. klinichnyi onkol. Sumy, Sums'ka Oblast, Ukraine, 40022[108]1250--"Ternopil obl klin onkodyspanser" TOR Ternopil, Ternopil's'ka Oblast, Ukraine, 46023[109]3161-Podilskyi rehionalnyi tsentr onkolohii, viddilennia khimioterapii Vinnytsia, Vinnyts'ka Oblast, Ukraine, 21029[110]1249---KP "Volynskyi obl med tsentr onkolohii" VOR Lutsk, Volyns'ka Oblast, Ukraine, 63000[111]1246-Komissiia z pytan Dnipro, Ukraine, 49102[112]2806---Zaporizhzhia Regional Antitumor Center Zaporizhzhia, Ukraine, 69040[113]Alabama Oncology Birmingham, Alabama, United States, 35235
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.
