転移性 HER2+ 乳癌に対するトラスツズマブおよびペルツズマブによるツカチニブまたはプラセボの研究 (HER2CLIMB-05)
転移性 HER2+ 乳がんの維持療法としてのツカチニブまたはプラセボとトラスツズマブおよびペルツズマブの併用のランダム化二重盲検第 III 相試験 (HER2CLIMB-05)
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.
Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in.
All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.
調査の概要
状態
条件
詳細な説明
Control arm: Placebo given orally twice daily plus trastuzumab and pertuzumab every 21 days
Experimental arm: Tucatinib 300 mg given orally twice daily plus trastuzumab and pertuzumab every 21 days
Trastuzumab and pertuzumab will be administered as follows:
• Trastuzumab will be given intravenously (IV) at a dose of 6 mg/kg or subcutaneously (SC) at a fixed dose of 600 mg, once every 21 days.
AND
- Pertuzumab will be given IV at 420 mg every 21 days. OR
- Fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given SC, once every 21 days, in lieu of trastuzumab and pertuzumab individually.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85054
- Mayo Clinic Hospital
-
Scottsdale、Arizona、アメリカ、85259
- Mayo Clinic
-
-
Arkansas
-
Little Rock、Arkansas、アメリカ、72205
- Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI
-
-
California
-
Beverly Hills、California、アメリカ、90212
- UCLA Hematology/Oncology - Beverly Hills
-
Burbank、California、アメリカ、91505
- UCLA Hematology/Oncology - Burbank
-
Encinitas、California、アメリカ、92024
- UCSD Medical Center - Encinitas
-
La Jolla、California、アメリカ、92093
- UC San Diego Moores Cancer Center
-
La Jolla、California、アメリカ、92037
- Sulpizio Cardiovascular Center at UC San Diego Health
-
La Jolla、California、アメリカ、92037
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
-
La Jolla、California、アメリカ、92037
- UCSD Perlman Medical Offices
-
La Jolla、California、アメリカ、92037
- UCSD Koman Family Outpatient Pavilion
-
Laguna Hills、California、アメリカ、92653
- UCLA Hematology/Oncology - Laguna Hills
-
Los Angeles、California、アメリカ、90095
- UCLA Hematology/Oncology
-
Los Angeles、California、アメリカ、90095
- Administrative Address: UCLA Hematology/Oncology
-
San Diego、California、アメリカ、92103
- UC San Diego Medical Center - Hillcrest
-
San Diego、California、アメリカ、912101
- UCSD Medical Center - Bankers Hill
-
San Luis Obispo、California、アメリカ、93401
- UCLA Hematology/Oncology - San Luis Obispo
-
Santa Barbara、California、アメリカ、93101
- UCLA Hematology/Oncology- Santa Barbara
-
Santa Monica、California、アメリカ、90404
- UCLA Hematology/Oncology - Santa Monica
-
Santa Monica、California、アメリカ、90404
- UCLA Hematology/Oncology Parkside
-
Torrance、California、アメリカ、90509
- Harbor-UCLA Medical Center
-
Torrance、California、アメリカ、90502
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
-
Torrance、California、アメリカ、90502
- Clinical And Translational Research Center
-
Valencia、California、アメリカ、91355
- UCLA Hematology/Oncology - Santa Clarita
-
Vista、California、アメリカ、92081
- UCSD Medical Center - Vista
-
Westlake Village、California、アメリカ、91361
- UCLA Hematology/Oncology- Westlake
-
-
Florida
-
Altamonte Springs、Florida、アメリカ、32701
- AdventHealth Altamonte Infusion Center
-
Altamonte Springs、Florida、アメリカ、32701
- AdventHealth Medical Group Altamonte(second location)
-
Altamonte Springs、Florida、アメリカ、32701
- AdventHealth Medical Group Altamonte
-
Jacksonville、Florida、アメリカ、32224
- Mayo Clinic Florida
-
Orlando、Florida、アメリカ、32804
- AdventHealth Orlando Infusion Center
-
Orlando、Florida、アメリカ、32804
- AdventHealth Medical Group Orlando
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30308
- Emory University Hospital Midtown
-
Atlanta、Georgia、アメリカ、30342
- Emory Saint Joseph's Hospital
-
Atlanta、Georgia、アメリカ、30322
- Winship Cancer Institute
-
Atlanta、Georgia、アメリカ、30322
- Emory University Clinic
-
-
Illinois
-
Chicago、Illinois、アメリカ、60612
- University of Illinois Hospital and Health Systems
-
Chicago、Illinois、アメリカ、60612
- University of Illinois Hospital and Health Systems (Outpatient Cancer Center)
-
Chicago、Illinois、アメリカ、60612
- University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy)
-
-
Kentucky
-
Louisville、Kentucky、アメリカ、40207
- Norton Cancer Institute, St. Matthews Campus
-
Louisville、Kentucky、アメリカ、40207
- Norton Cancer Institute, St Matthews Campus
-
Louisville、Kentucky、アメリカ、40241
- Norton Cancer Institute, Brownsboro Hospital Campus
-
Louisville、Kentucky、アメリカ、40202
- Norton Cancer Institute, Downtown
-
Louisville、Kentucky、アメリカ、40202
- Norton Cancer Institute - Downtown
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21202
- Mercy Medical Center
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
-
-
Missouri
-
Kansas City、Missouri、アメリカ、64111
- Saint Luke's Cancer Institute.
-
-
Nebraska
-
Grand Island、Nebraska、アメリカ、68803
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
-
Grand Island、Nebraska、アメリカ、68803
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha、Nebraska、アメリカ、68130
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha、Nebraska、アメリカ、68124
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha、Nebraska、アメリカ、68114
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Papillion、Nebraska、アメリカ、68046
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
-
New Jersey
-
Jersey City、New Jersey、アメリカ、07302
- RWJBarnabas Health- Jersey City Medical Center
-
Lakewood、New Jersey、アメリカ、08701
- RWJBarnabas Health- Monmouth Medical Center-Southern Campus
-
Livingston、New Jersey、アメリカ、07039
- RWJBarnabas Health- Cooperman Barnabas Medical Center
-
Long Branch、New Jersey、アメリカ、07740
- RWJBarnabas Health- Monmouth Medical Center
-
New Brunswick、New Jersey、アメリカ、08903
- Rutgers Cancer Institute of New Jersey
-
Newark、New Jersey、アメリカ、07112
- Newark Beth Israel Medical Center
-
Somerville、New Jersey、アメリカ、08876
- Steeplechase Cancer Center
-
Somerville、New Jersey、アメリカ、08876
- RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset
-
Toms River、New Jersey、アメリカ、08755
- RWJBarnabas Health - Community Medical Center
-
West Long Branch、New Jersey、アメリカ、07764
- Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center
-
-
New York
-
The Bronx、New York、アメリカ、10461
- Montefiore Einstein Comprehensive Cancer Center
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic
-
Cleveland、Ohio、アメリカ、44106
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
-
Strongsville、Ohio、アメリカ、44136
- Cleveland Clinic Cancer Center - Strongsville
-
-
Pennsylvania
-
Willow Grove、Pennsylvania、アメリカ、19090
- Asplundh Cancer Pavillion
-
-
Tennessee
-
Gallatin、Tennessee、アメリカ、37066
- Tennessee Oncology, PLLC
-
Murfreesboro、Tennessee、アメリカ、37129
- Tennessee Oncology, PLLC
-
Nashville、Tennessee、アメリカ、37203
- Tennessee Oncology, PLLC
-
Nashville、Tennessee、アメリカ、37203
- Sarah Cannon Research Institute- Pharmacy
-
Shelbyville、Tennessee、アメリカ、37160
- Tennessee Oncology, PLLC
-
-
Washington
-
Seattle、Washington、アメリカ、98195
- University of Washington Medical Center
-
Seattle、Washington、アメリカ、98109
- Fred Hutchinson Cancer Center
-
-
Wisconsin
-
Milwaukee、Wisconsin、アメリカ、53226
- Froedtert Hospital/Medical College of Wisconsin
-
-
-
-
-
London、イギリス、SW3 6JJ
- The Royal Marsden
-
London、イギリス、N12 0JE
- Finchley Memorial Hospital
-
London、イギリス、NW1 2PG
- University College London Hospital (UCLH) NHS Foundation Trust
-
Manchester、イギリス、M20 4BX
- Christie Hospital NHS Foundation Trust
-
-
England
-
London、England、イギリス、NW3 2QG
- Academic Oncology
-
-
Surrey
-
Sutton、Surrey、イギリス、SM2 5PT
- The Royal Marsden
-
-
-
-
-
Bologna、イタリア、40138
- Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
-
Bologna、イタリア、40138
- SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi
-
Milan、イタリア、20089
- Istituto Clinico Humanitas
-
Milan、イタリア、20141
- Divisione di Senologia Medica; Istituto Europeo di Oncologia
-
Parma、イタリア、43126
- UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma
-
Pavia、イタリア、27100
- Istituti Clinici Scientifici Maugeri IRCCS
-
-
Campania
-
Naples、Campania、イタリア、80131
- Azienda Ospedaliera Universitaria Federico II
-
Naples、Campania、イタリア、80131
- lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica
-
-
Liguria
-
Genoa、Liguria、イタリア、16132
- IRCCS Ospedale Policlinico, San Martino
-
-
Lombardy
-
Monza (MB)、Lombardy、イタリア、20900
- ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1
-
-
Sicily
-
Catania (CT)、Sicily、イタリア、95045
- Humanitas lstituto Clinico Catanese
-
-
The Marches
-
Torrette、The Marches、イタリア、60126
- Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica
-
-
Trentino-Alto Adige
-
Trento、Trentino-Alto Adige、イタリア、38122
- Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara
-
Trento、Trentino-Alto Adige、イタリア、38122
- SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO)
-
-
Tuscany
-
Livorno、Tuscany、イタリア、57124
- Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor
-
Prato、Tuscany、イタリア、59100
- S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano
-
-
-
-
-
Dordrecht、オランダ、3318 AT
- Albert Schweitzer Ziekenhuis
-
Utrecht、オランダ、3543 AZ
- St. Antonius Hospital
-
Venlo、オランダ、5912 BL
- VieCuri Medsich Centrum
-
-
South Holland
-
Doedrecht、South Holland、オランダ、3318AT
- Albert Schweitzer Hospital
-
-
-
-
New South Wales
-
Camperdown、New South Wales、オーストラリア、2050
- Chris O'Brien Lifehouse
-
Macquarie University、New South Wales、オーストラリア、2109
- Macquarie University Clinical Trials Unit.
-
Westmead、New South Wales、オーストラリア、2145
- Western Sydney Local Health District (WSLHD), Westmead Hospital
-
-
South Australia
-
Adelaide、South Australia、オーストラリア、5000
- Cancer Research SA
-
Adelaide、South Australia、オーストラリア、5000
- St Andrews Medical Centre
-
Bedford Park、South Australia、オーストラリア、5042
- Flinders Medical Centre
-
-
Victoria
-
Box Hill、Victoria、オーストラリア、3128
- Box Hill Hospital
-
Heidelberg、Victoria、オーストラリア、3084
- Austin Health
-
-
Washington
-
Subiaco、Washington、オーストラリア、6008
- St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre
-
-
-
-
-
Graz、オーストリア、A-8010
- Medizinische Universität Graz
-
Graz、オーストリア、A-8036
- Medizinische Universitat Graz
-
Linz、オーストリア、A-4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
-
Vienna、オーストリア、A-1090
- Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde
-
-
Other
-
Schwaz、Other、オーストリア、A-6130
- Ordination Priv.-Doz. Dr. Michael Hubalek
-
-
-
-
Alberta
-
Edmonton、Alberta、カナダ、T6G 1Z2
- Cross Cancer Institute
-
-
British Columbia
-
Kelowna、British Columbia、カナダ、V1Y 5L3
- BC Cancer Agency
-
-
Ontario
-
Ottawa、Ontario、カナダ、K1H 8L6
- The Ottawa Hospital Cancer Centre
-
Toronto、Ontario、カナダ、M5G 1X5
- Mount Sinai Hospital
-
Toronto、Ontario、カナダ、M4N 3M5
- Sunnybrook Research Institute
-
-
Quebec
-
Chicoutimi、Quebec、カナダ、G7H 5H6
- Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
-
Montreal、Quebec、カナダ、H3T 1E2
- Jewish General Hospital
-
Montreal、Quebec、カナダ、H2X 3E4
- Centre Hospitalier de l'Universite de Motreal (CHUM)
-
-
-
-
-
Larissa、ギリシャ、41110
- University General Hospital of Larissa, Oncology Clinic
-
Marousi、ギリシャ、15123
- IASO General Clinic Oncology Clinic
-
Pireaus、ギリシャ、18537
- Metaxa Anticancer Hospital of Piraeus
-
-
Attica
-
Athens、Attica、ギリシャ、11528
- General Hospital of Athens "Alexandra" Clinical Therapeutics Department, Hematology/Oncology Unit
-
-
Peloponnese
-
Patra、Peloponnese、ギリシャ、26504
- University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
-
-
-
-
-
Baden、スイス、5404
- Kantonsspital Baden.
-
Zurich、スイス、8008
- Brust-Zentrum AG
-
-
Canton of Zurich
-
Winterthur、Canton of Zurich、スイス、8401
- Kantonsspital Winterthur
-
-
-
-
-
Barcelona、スペイン、08035
- Hospital Universitari Vall d'Hebron
-
Barcelona、スペイン、08035
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
-
Barcelona、スペイン、08025
- Fundacio de Gestio Sanitaria de I'Hospital de la Santa Creu i Sant Pau
-
Barcelona、スペイン、08041
- Hospital de la Santa Creu i Sant Pau
-
Bilbao、スペイン、48013
- Hospital Universitario de Basurto
-
Girona、スペイン、17007
- Institut Catala d'Oncologia Girona - ICO Girona
-
Granada、スペイン、18014
- Hospital Universitario Virgen de las Nieves
-
Lleida、スペイン、25198
- Hospital Universitari Arnau de Vilanova
-
Madrid、スペイン、28007
- Hospital General Universitario Gregorio Maranon
-
Málaga、スペイン、29010
- Hospital Universitario Virgen de la Victoria
-
Salamanca、スペイン、37007
- Hospital Universitario de Salamanca (Spain Salamanca)
-
Seville、スペイン、41013
- Hospital Universitario Virgen del Rocio
-
Valencia、スペイン、46009
- Fundacion lnstituto Valenciano de Oncologia
-
-
Andalusia
-
Málaga、Andalusia、スペイン、29016
- Hospital El Angel Grupo Hla, S.L.U
-
-
Balearic Islands
-
Palma de Mallorca、Balearic Islands、スペイン、07120
- Hospital Universitario Son Espases
-
-
Murcia
-
EI Palmar、Murcia、スペイン、30120
- Hospital Universitario Virgen De La Arrixaca
-
-
Other
-
Barcelona、Other、スペイン、08035
- Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
-
Cáceres、Other、スペイン、10003
- Hospital San Pedro de Alcantara
-
Madrid、Other、スペイン、28034
- Hospital Universitario Ramon y Cajal
-
Valencia、Other、スペイン、46010
- Hospital Clinico Universitario de Valencia
-
-
Santa CRUZ DE Tenerife
-
La Laguna Tenerife、Santa CRUZ DE Tenerife、スペイン、38320
- Hospital Universitario de Canarias
-
-
Valencia
-
Alicante、Valencia、スペイン、03010
- Hospital General Universitario Alicante
-
-
-
-
-
Brno、チェコ、656 53
- Masarykuv Onkologicky Ustav
-
Prague、チェコ、128 08
- Vseobecna fakultni nemocnice v Praze
-
Praha 5 - Motol、チェコ、15006
- Nemocnicni lekarna Fakultni nemocnice v Motole
-
Praha 5 - Motol、チェコ、15006
- Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol
-
-
Other
-
Brno、Other、チェコ、656 53
- Ustavni lekarna Masarykuv onkologicky ustav
-
Praha 4 - Krc、Other、チェコ、14059
- Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN
-
-
-
-
-
Talca、チリ、3460000
- Clinica Universidad Catolica del Maule
-
Temuco、チリ、4810297
- Clinica Alemana Temuco
-
Temuco、チリ、4810469
- James Lind Centro De Investigacion Del Cancer
-
-
Santiago Metropolitan
-
Recoleta、Santiago Metropolitan、チリ、8420323
- Centro de Investigacion Clínica Bradford Hill
-
-
Valparaiso
-
Viña del Mar、Valparaiso、チリ
- Oncocentro Apys
-
-
-
-
-
Augsburg、ドイツ、86156
- "Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe"
-
Berlin、ドイツ、10117
- Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum
-
Berlin、ドイツ、13353
- Charite - Universitatsmedizin Berlin
-
Hamburg、ドイツ、20246
- Universitatsklinikum Hamburg-Eppendorf (UKE)
-
München、ドイツ、81675
- Klinik und Poliklinik fur Frauenheilkunde der Technischen Universitat Munchen
-
Ulm、ドイツ、89075
- Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe
-
Würzburg、ドイツ、97080
- Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
-
Würzburg、ドイツ、97080
- Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF)
-
-
North Rhine-Westphalia
-
Münster、North Rhine-Westphalia、ドイツ、48149
- University Hospital Muenster Senology
-
-
Other
-
Manheim、Other、ドイツ、68167
- Universitätsmedizin Mannheim Universitätsfrauenklinik
-
Mannheim、Other、ドイツ、68167
- Pharmacy:Fortuna Herstellung GmbH
-
-
-
-
-
Tampere、フィンランド
- Tampere University Hospital
-
Tampere、フィンランド、33520
- Tampere University Hospital, FONK/RSYO
-
-
-
-
-
Besançon、フランス、25000
- CHU Besancon
-
Bobigny、フランス、93009 Cedex
- Hopital Avicenne
-
Caen、フランス、14076 Cedex 5
- CENTRE FRANCOIS BACLESSE - Service lmagerie medicale
-
Caen、フランス、14076
- Centre de Lutte contre le Cancer - François Baclesse
-
Caen、フランス、14076 Cedex 5
- Centre Francois Baclesse
-
Clermont-Ferrand、フランス、63000
- Centre Jean Perrin
-
Lille、フランス、59020 Cedex
- Centre Oscar Lambret
-
Lyon、フランス、69373 Cedex 08
- Center Leon Berard
-
Montpellier、フランス、34298 Cedex 5
- Institut Regional du Cancer de Montpellier Service lmagerie medicale
-
Montpellier、フランス、34298
- Institut Régional du Cancer de Montpellier
-
Nice、フランス、06189
- Centre Antoine Lacassagne
-
Pierre-Bénite、フランス、69310
- Hospices Civils de Lyon
-
Plérin、フランス、22190
- "CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des
-
Rennes、フランス、cedex 35042
- Centre Eugene Marquis
-
Rouen、フランス、76038 Cedex 1
- Centre Henri Becquerel
-
Saint-Cloud、フランス、92210
- Institut Curie - site St-Cloud
-
Strasbourg、フランス、67033
- Institut de Cancerologie Strasbourg Europe
-
-
Brittany Region
-
Rouen、Brittany Region、フランス、76038
- Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
-
-
Cedex
-
Bordeaux、Cedex、フランス、33076
- Institut Bergonie
-
-
Languedoc-roussillon
-
Montpellier、Languedoc-roussillon、フランス、34070
- Centre de Cancérologie du Grand Montpellier
-
-
Loire-atlantique
-
Saint-Herblain、Loire-atlantique、フランス、44800
- Institut de Cancerologie de lOuest - Site Rene Gauducheau
-
Saint-Herblain、Loire-atlantique、フランス、44805
- Institut de Cancerologie de lOuest-Saint Herblain
-
-
Other
-
Avignon、Other、フランス、84918
- Institut Sainte-Catherine.
-
Avignon、Other、フランス、84918
- Sainte Catherine lnstitut du Cancer Avignon Provence
-
Dijon、Other、フランス、21079
- Center Georges-Francois Leclerc
-
-
-
-
-
Porto Alegre/RS、ブラジル、90050-170
- Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica
-
São José do Rio Preto、ブラジル、15090-000
- Faculdade Regional de Medicina de Sao Jose do Rio Preto
-
São Paulo、ブラジル、01246-000
- ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
-
São Paulo、ブラジル、04014-002
- Sao Camilo Oncologia
-
São Paulo、ブラジル、CEP: 01317-000
- Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
-
-
Ceará
-
Fortaleza、Ceará、ブラジル、60336-232
- CRIO - Centro Regional lntegrado de Oncologia
-
-
Goiás
-
Goiânia、Goiás、ブラジル、74605-070
- Hospital Araujo Jorge
-
-
Other
-
Sao Paulo/SP、Other、ブラジル、01.509-010
- A.C. Camargo Câncer Center
-
-
Paraná
-
Londrina、Paraná、ブラジル、86015-520
- Hospital Do Cancer De Londrina
-
-
Rio Grande do Norte
-
Natal、Rio Grande do Norte、ブラジル、59075-740
- Liga Norte-Rio Grandense Contra o Cancer
-
-
Rio Grande do Sul
-
Porto Alegre、Rio Grande do Sul、ブラジル、90035-903
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre、Rio Grande do Sul、ブラジル、CEP 90110-270
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
-
Porto Alegre、Rio Grande do Sul、ブラジル、CEP 90850-170
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
-
-
São Paulo
-
Barretos、São Paulo、ブラジル、CEP: 14784-400
- Fundacao Pio XII, Hospital do Amor de Barretos
-
Jaú、São Paulo、ブラジル、CEP: 17210-080
- Fundacao Dr Amaral Carvalho
-
Santo André、São Paulo、ブラジル、09060-650
- CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia
-
Santo André、São Paulo、ブラジル、09060-870
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
-
-
-
-
-
Anderlecht、ベルギー、1070
- Jules Bordet lnstituut
-
Brussels、ベルギー、1090
- Universitair Ziekenhuis Brussel (UZ Brussel)
-
Brussels、ベルギー、1200
- Cliniques Universitaires Saint-Luc
-
Ottignies、ベルギー、1340
- Clinique St-Pierre
-
-
-
-
-
Coimbra、ポルトガル、3000-075
- Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
-
Lisbon、ポルトガル、1400-038
- Fundacao Champalimaud
-
-
Other
-
Braga、Other、ポルトガル、4710-243
- Centro Clinico Academico Braga Hospital de Braga
-
Lisbon、Other、ポルトガル、1998-018
- Hospital CUF Descobertas
-
-
-
-
-
Gdansk、ポーランド、80-214
- Uniwersyteckie Centrum Kliniczne
-
Lodz、ポーランド、91-211
- Salve Medica
-
Lodz、ポーランド、91-211
- Salve Medica Apteka Szpitalna
-
Opole、ポーランド、45-061
- SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu
-
-
Other
-
Lodz、Other、ポーランド、93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
-
Silesian Voivodeship
-
Gliwice、Silesian Voivodeship、ポーランド、44-102
- Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy
-
-
-
-
-
Beijing、中国、100730
- Beijing Hospital
-
Beijing、中国、100010
- Beijing Hospital
-
Shanghai、中国、200032
- Fudan University Shanghai Cancer Center
-
Tianjin、中国、300181
- Tianjin Cancer Hospital Binhai Campus
-
-
Anhui
-
Hefei、Anhui、中国、230601
- The Second Hospital of Anhui Medical University
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510080
- Guangdong Provincial People's Hospital
-
Meizhou、Guangdong、中国、514031
- Meizhou People's Hospital
-
-
Guangxi
-
Liuzhou、Guangxi、中国、545006
- Liuzhou People's Hospital
-
Nanning、Guangxi、中国、530021
- The People's Hospital of Guangxi Zhuang Autonomous Region
-
Nanning、Guangxi、中国、530021
- Guangxi Medical University Affiliated Tumor Hospital
-
-
Hainan
-
Haikou、Hainan、中国、570102
- The first Affiliated Hospital of Hainan Medical University
-
-
Hebei
-
Baoding、Hebei、中国、071000
- Affiliated Hospital of Hebei University
-
-
Henan
-
Zhengzhou、Henan、中国、450003
- Henan Cancer Hospital
-
-
Hubei
-
Wuhan、Hubei、中国、430079
- Hubei Cancer Hospital
-
Wuhan、Hubei、中国、430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
-
-
Hunan
-
Changsha、Hunan、中国、410011
- The Second Xiangya Hospital of Central South University
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210036
- Nanjing Medical University (NMU) - Jiangsu Province Hospital
-
-
Jiangxi
-
Nanchang、Jiangxi、中国、330008
- The Second Affiliated Hospital of Nanchang University
-
-
Jilin
-
Changchun、Jilin、中国、130021
- The First Hospital of Jilin University
-
-
Liaoning
-
Shenyang、Liaoning、中国、110042
- Liaoning Cancer Hospital & Insitute
-
Shenyang、Liaoning、中国、110167
- The First Affiliated Hospital of China Medical University
-
-
Other
-
Shanghai、Other、中国、200025
- Ruijin Hospital of Shanghai Jiaotong University School of Medicine
-
-
Shaanxi
-
Xi'an、Shaanxi、中国、710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Xi'an、Shaanxi、中国、710068
- Shaanxi Provincial People's Hospital
-
-
Shandong
-
Jinan、Shandong、中国、250013
- Jinan Central Hospital
-
Linyi、Shandong、中国、276034
- Linyi Cancer Hospital
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Hangzhou、Zhejiang、中国、310005
- Zhejiang Cancer Hospital
-
Hangzhou、Zhejiang、中国、310052
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
-
-
-
-
Changhua、台湾、500 (R.O.C.)
- Changhua Christian Medical Foundation Changhua Christian Hospital
-
Kaohsiung City、台湾、807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
New Taipei City、台湾、23561 (R.O.C.)
- Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
-
New Taipei City、台湾、23561 (R.O.C)
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
-
Taichung、台湾、40447 (R.O.C.)
- China Medical University Hospital
-
Taipei、台湾、11217
- Taipei Veterans General Hospital
-
Taipei、台湾、11490, R.O.C.
- Tri-Service General Hospital
-
Taoyuan City、台湾、333
- Chang Gung Memorial Hospital LinKou
-
-
Other
-
Tainan、Other、台湾、704
- National Cheng Kung University Hospital
-
Taipei、Other、台湾、10449
- MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
-
Taipei、Other、台湾、112
- Koo Foundation Sun Yat-Sen Cancer Center
-
-
R.o.c
-
Taipei、R.o.c、台湾、100
- National Taiwan University Hospital
-
-
Tainan
-
Tainan、Tainan、台湾、710
- Chi Mei Medical Center
-
-
-
-
Chiba
-
Kamogawa、Chiba、日本、296-8602
- Tesshokai Kameda General Hospital
-
Kashiwa-Shi、Chiba、日本、277-8577
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama、Ehime、日本、791-0280
- NHO Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka、Fukuoka、日本、811-1395
- National Hospital Organization Kyushu Cancer Center
-
-
Fukushima
-
Fukushima、Fukushima、日本、960-1295
- Fukushima Medical University Hospital
-
-
Hokkaido
-
Sapporo、Hokkaido、日本、003-0804
- National Hospital Organization Hokkaido Cancer Center
-
-
Ibaraki
-
Tsukuba、Ibaraki、日本、305-8576
- University of Tsukuba Hospital
-
-
Ishikawa-ken
-
Kanazawa、Ishikawa-ken、日本、920-8530
- Ishikawa Prefectural Central Hospital
-
-
Kanagawa
-
Yokohama、Kanagawa、日本、241-8515
- Kanagawa Cancer Center
-
-
Okinawa
-
Naha、Okinawa、日本、901-0154
- Naha Nishi Clinic
-
-
Osaka
-
Osakasayama-shi、Osaka、日本、589-8511
- Kindai University Hospital
-
Sakai、Osaka、日本、590-0197
- Kindai University Hospital
-
-
Tokyo
-
Chuo-ku、Tokyo、日本、104-0045
- National Cancer Center Hospital
-
Chuo-ku、Tokyo、日本、104-8560
- St. Luke's International Hospital.
-
Minato-ku、Tokyo、日本、105-8470
- Toranomon Hospital
-
Shinagawa-ku、Tokyo、日本、142-8666
- Showa University Hospital
-
-
-
-
-
Busan、韓国、49201
- Dong-A University Hospital
-
Incheon、韓国、21565
- Gachon University Gil Medical Center
-
Seoul、韓国、02841
- Korea University Anam Hospital
-
-
Gangwon-do
-
Wŏnju、Gangwon-do、韓国、26426
- Yonsei University Wonju Severance Christian Hospital
-
-
Gyeonggi-do
-
Goyang-si、Gyeonggi-do、韓国、10408
- National Cancer Center
-
Seongnam-si、Gyeonggi-do、韓国、13620
- Seoul National University Bundang Hospital
-
Suwon、Gyeonggi-do、韓国、16247
- The Catholic University of Korea, St. Vincent's Hospital
-
Suwon、Gyeonggi-do、韓国、16499
- Ajou University Hospital
-
-
North Chungcheong
-
Cheongju-si、North Chungcheong、韓国、28644
- Chungbuk Nationl University Hospital
-
-
Other
-
Seoul、Other、韓国、03080
- Seoul National University Hospital
-
Seoul、Other、韓国、05505
- Asan Medical Center
-
Seoul、Other、韓国、06273
- Gangnam Severance Hospital, Yonsei University Health System
-
Seoul、Other、韓国、06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul、Other、韓国、07985
- Ewha Womans University Mokdong Hospital
-
-
Seoul-teukbyeolsi [seoul]
-
Seoul、Seoul-teukbyeolsi [seoul]、韓国、03722
- Severance Hospital Yonsei University Health System
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Centrally confirmed HER2+ breast carcinoma according to the 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines prior to randomization (defined as a 3+ score on immunohistochemistry (IHC) and/or 2+ IHC and concurrent positive by ISH).
-
Have unresectable locally advanced or metastatic disease.
- If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
-
Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.
-
Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])
-
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-
CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following:
-
No evidence of brain metastases
-
Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane
-
Previously treated brain metastases which are asymptomatic
- Brain metastases previously treated with local therapy must not have progressed since treatment
-
Exclusion Criteria:
-
Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug)
-
Unable to undergo contrast-enhanced MRI of the brain
-
CNS Exclusion - Based on screening brain MRI and clinical assessment
- Symptomatic brain metastasis after CNS-directed local therapy
- Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane
- Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of dexamethasone (or equivalent)
- Any untreated brain lesion in an anatomic site which may pose risk to participant
- Known or suspected leptomeningeal disease (LMD)
- Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Tucatinib + trastuzumab + pertuzumab
Tucatinib + trastuzumab + pertuzumab |
300mg given by mouth (orally) twice daily
他の名前：
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
他の名前：
420mg given by IV every 21 days
他の名前：
600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.
他の名前：
|
|
アクティブコンパレータ：Placebo + trastuzumab + pertuzumab
Placebo + trastuzumab + pertuzumab |
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
他の名前：
420mg given by IV every 21 days
他の名前：
600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.
他の名前：
Given orally twice daily |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
時間枠：From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
PFS: time from randomization to the first documented disease progression (PD) (as assessed by investigator per RECIST 1.1) or death from any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum of diameter recorded since the treatment started or the appearance of 1 or more new lesions. Participants without documentation of PD/ death at the time of analysis, were censored at date of last tumor assessment with an overall response of complete response (CR), partial response (PR), stable disease (SD), non-CR/non-PD or no evidence of disease (NED). CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis. |
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival (OS)
時間枠：From the date of randomization until date of death or censoring date (approximately 66.7 months)
|
OS: time from randomization to death due to any cause. For a participant who would not known to have died by the end of study follow-up, observation of OS would be censored on the date the participant was last known to be alive (i.e., the date of last contact). |
From the date of randomization until date of death or censoring date (approximately 66.7 months)
|
|
PFS as Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1
時間枠：From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
PFS per BICR was defined as the time from the date of randomization to the documented disease progression assessed by BICR according to RECIST v1.1 or death from any cause, whichever occurred first. As per RECIST v1.1, PD: >=20% increase in sum of diameter of target lesions, taking as reference the smallest sum of diameters recorded since treatment started or appearance of 1 or more new lesions, unequivocal progression of existing non-target lesions. Participants without documentation of PD/ death were censored at date of last tumor assessment with an overall response of CR, PR, SD, non-CR/non-PD or NED. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis. |
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
|
Time to Deterioration (TTD) of Health-Related Quality of Life (HRQoL)
時間枠：Approximately 66.7 months
|
Time to deterioration of HRQoL was defined as time to 10-point decrease in the global health status/QoL scale of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30). EORTC QLQ-C30 is 30 item questionnaires composed of 5 multi-item functional domains (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea, and vomiting) and 6 single items for symptoms (shortness of breath, loss of appetite, sleep disturbance, constipation, diarrhea and financial impact of the disease), 2 global items (health, overall QoL). Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. |
Approximately 66.7 months
|
|
Central Nervous System (CNS) PFS as Assessed by Investigator Per RECIST v1.1
時間枠：From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
CNS-PFS was defined as the time from randomization to investigator assessed disease progression in brain according to RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, PD: >= 20% increase in sum of diameter of target lesions, taking as reference the smallest sum of diameters recorded since the treatment started or appearance of 1 or more new lesions, unequivocal progression of existing non-target lesions. Participants without documentation of PD/ death at the time of analysis were censored at date of last tumor assessment with an overall response of CR, PR, SD, non-CR/non-PD or NED. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis. |
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
時間枠：From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)
|
An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. AEs included both Serious AE (SAEs) and all other AEs. An AE should be classified as a serious SAE if it meets one of the following criteria: fatal, life threatening, requires or prolongs hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities
時間枠：From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. Treatment emergent laboratory abnormalities include: hematology (hemoglobin decreased, hemoglobin increased, leukocytes decreased, neutrophils decreased, platelets decreased); chemistry (alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, creatinine increased, potassium decreased, potassium increased, sodium decreased, sodium increased, total bilirubin increased). |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Number of Participants With TEAEs Leading to Dose Discontinuations
時間枠：From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose discontinuations with study treatment will be reported. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Number of Participants With TEAEs Leading to Dose Hold
時間枠：From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose hold with study treatment will be reported. Dose hold requirements are defined per protocol. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Number of Participants With TEAEs Leading to Dose Reductions
時間枠：From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose reductions with tucatinib, trastuzumab and pertuzumab are reported. Dose reduction requirements are defined per protocol. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Trough Concentration (Ctrough) of Tucatinib
時間枠：Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6
|
Concentration at Trough was defined as predose/trough concentration observed directly from data. |
Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With TEAEs: Through Study Completion
時間枠：From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
An AE was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. AEs included both SAEs and all other AEs. An AE should be classified as a serious SAE if it meets one of the following criteria: fatal, life threatening, requires or prolongs hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
協力者と研究者
捜査官
- スタディディレクター：Pfizer CT.gov Call Center、Pfizer
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SGNTUC-028
- C4251007 (その他の識別子：Alias Study Number)
- 2023-503826-37-00 (レジストリ識別子：CTIS (EU))
- 2023 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。