Studie Tucatinibu nebo placeba s trastuzumabem a pertuzumabem pro metastatický HER2+ karcinom prsu (HER2CLIMB-05)
Randomizovaná, dvojitě zaslepená studie fáze 3 tucatinibu nebo placeba v kombinaci s trastuzumabem a pertuzumabem jako udržovací léčba metastatického karcinomu prsu HER2+ (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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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New South Wales
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Camperdown, New South Wales, Austrálie, 2050
- Chris O'Brien Lifehouse
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Macquarie University, New South Wales, Austrálie, 2109
- Macquarie University Clinical Trials Unit.
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Westmead, New South Wales, Austrálie, 2145
- Western Sydney Local Health District (WSLHD), Westmead Hospital
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South Australia
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Adelaide, South Australia, Austrálie, 5000
- Cancer Research SA
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Adelaide, South Australia, Austrálie, 5000
- St Andrews Medical Centre
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Bedford Park, South Australia, Austrálie, 5042
- Flinders Medical Centre
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Victoria
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Box Hill, Victoria, Austrálie, 3128
- Box Hill Hospital
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Heidelberg, Victoria, Austrálie, 3084
- Austin Health
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Washington
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Subiaco, Washington, Austrálie, 6008
- St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre
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Anderlecht, Belgie, 1070
- Jules Bordet lnstituut
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Brussels, Belgie, 1090
- Universitair Ziekenhuis Brussel (UZ Brussel)
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Brussels, Belgie, 1200
- Cliniques Universitaires Saint-Luc
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Ottignies, Belgie, 1340
- Clinique St-Pierre
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-
-
-
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Porto Alegre/RS, Brazílie, 90050-170
- Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica
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São José do Rio Preto, Brazílie, 15090-000
- Faculdade Regional de Medicina de Sao Jose do Rio Preto
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São Paulo, Brazílie, 01246-000
- ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
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São Paulo, Brazílie, 04014-002
- Sao Camilo Oncologia
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São Paulo, Brazílie, CEP: 01317-000
- Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
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Ceará
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Fortaleza, Ceará, Brazílie, 60336-232
- CRIO - Centro Regional lntegrado de Oncologia
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Goiás
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Goiânia, Goiás, Brazílie, 74605-070
- Hospital Araujo Jorge
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Other
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Sao Paulo/SP, Other, Brazílie, 01.509-010
- A.C. Camargo Câncer Center
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Paraná
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Londrina, Paraná, Brazílie, 86015-520
- Hospital Do Cancer De Londrina
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brazílie, 59075-740
- Liga Norte-Rio Grandense Contra o Cancer
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazílie, 90035-903
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brazílie, CEP 90110-270
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
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Porto Alegre, Rio Grande do Sul, Brazílie, CEP 90850-170
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
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São Paulo
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Barretos, São Paulo, Brazílie, CEP: 14784-400
- Fundacao Pio XII, Hospital do Amor de Barretos
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Jaú, São Paulo, Brazílie, CEP: 17210-080
- Fundacao Dr Amaral Carvalho
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Santo André, São Paulo, Brazílie, 09060-650
- CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia
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Santo André, São Paulo, Brazílie, 09060-870
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
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-
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Talca, Chile, 3460000
- Clinica Universidad Catolica del Maule
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Temuco, Chile, 4810297
- Clinica Alemana Temuco
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Temuco, Chile, 4810469
- James Lind Centro De Investigacion Del Cancer
-
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Santiago Metropolitan
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Recoleta, Santiago Metropolitan, Chile, 8420323
- Centro de Investigacion Clínica Bradford Hill
-
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Valparaiso
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Viña del Mar, Valparaiso, Chile
- Oncocentro Apys
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-
-
-
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Tampere, Finsko
- Tampere University Hospital
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Tampere, Finsko, 33520
- Tampere University Hospital, FONK/RSYO
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-
-
-
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Besançon, Francie, 25000
- CHU Besancon
-
Bobigny, Francie, 93009 Cedex
- Hopital Avicenne
-
Caen, Francie, 14076 Cedex 5
- CENTRE FRANCOIS BACLESSE - Service lmagerie medicale
-
Caen, Francie, 14076
- Centre de Lutte contre le Cancer - François Baclesse
-
Caen, Francie, 14076 Cedex 5
- Centre Francois Baclesse
-
Clermont-Ferrand, Francie, 63000
- Centre Jean Perrin
-
Lille, Francie, 59020 Cedex
- Centre Oscar Lambret
-
Lyon, Francie, 69373 Cedex 08
- Center Leon Berard
-
Montpellier, Francie, 34298 Cedex 5
- Institut Regional du Cancer de Montpellier Service lmagerie medicale
-
Montpellier, Francie, 34298
- Institut Régional du Cancer de Montpellier
-
Nice, Francie, 06189
- Centre Antoine Lacassagne
-
Pierre-Bénite, Francie, 69310
- Hospices Civils de Lyon
-
Plérin, Francie, 22190
- "CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des
-
Rennes, Francie, cedex 35042
- Centre Eugene Marquis
-
Rouen, Francie, 76038 Cedex 1
- Centre Henri Becquerel
-
Saint-Cloud, Francie, 92210
- Institut Curie - site St-Cloud
-
Strasbourg, Francie, 67033
- Institut de Cancerologie Strasbourg Europe
-
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Brittany Region
-
Rouen, Brittany Region, Francie, 76038
- Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
-
-
Cedex
-
Bordeaux, Cedex, Francie, 33076
- Institut Bergonie
-
-
Languedoc-roussillon
-
Montpellier, Languedoc-roussillon, Francie, 34070
- Centre de Cancérologie du Grand Montpellier
-
-
Loire-atlantique
-
Saint-Herblain, Loire-atlantique, Francie, 44800
- Institut de Cancerologie de lOuest - Site Rene Gauducheau
-
Saint-Herblain, Loire-atlantique, Francie, 44805
- Institut de Cancerologie de lOuest-Saint Herblain
-
-
Other
-
Avignon, Other, Francie, 84918
- Institut Sainte-Catherine.
-
Avignon, Other, Francie, 84918
- Sainte Catherine lnstitut du Cancer Avignon Provence
-
Dijon, Other, Francie, 21079
- Center Georges-Francois Leclerc
-
-
-
-
-
Dordrecht, Holandsko, 3318 AT
- Albert Schweitzer Ziekenhuis
-
Utrecht, Holandsko, 3543 AZ
- St. Antonius Hospital
-
Venlo, Holandsko, 5912 BL
- VieCuri Medsich Centrum
-
-
South Holland
-
Doedrecht, South Holland, Holandsko, 3318AT
- Albert Schweitzer Hospital
-
-
-
-
-
Bologna, Itálie, 40138
- Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
-
Bologna, Itálie, 40138
- SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi
-
Milan, Itálie, 20089
- Istituto Clinico Humanitas
-
Milan, Itálie, 20141
- Divisione di Senologia Medica; Istituto Europeo di Oncologia
-
Parma, Itálie, 43126
- UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma
-
Pavia, Itálie, 27100
- Istituti Clinici Scientifici Maugeri IRCCS
-
-
Campania
-
Naples, Campania, Itálie, 80131
- Azienda Ospedaliera Universitaria Federico II
-
Naples, Campania, Itálie, 80131
- lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica
-
-
Liguria
-
Genoa, Liguria, Itálie, 16132
- IRCCS Ospedale Policlinico, San Martino
-
-
Lombardy
-
Monza (MB), Lombardy, Itálie, 20900
- ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1
-
-
Sicily
-
Catania (CT), Sicily, Itálie, 95045
- Humanitas lstituto Clinico Catanese
-
-
The Marches
-
Torrette, The Marches, Itálie, 60126
- Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica
-
-
Trentino-Alto Adige
-
Trento, Trentino-Alto Adige, Itálie, 38122
- Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara
-
Trento, Trentino-Alto Adige, Itálie, 38122
- SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO)
-
-
Tuscany
-
Livorno, Tuscany, Itálie, 57124
- Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor
-
Prato, Tuscany, Itálie, 59100
- S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano
-
-
-
-
Chiba
-
Kamogawa, Chiba, Japonsko, 296-8602
- Tesshokai Kameda General Hospital
-
Kashiwa-Shi, Chiba, Japonsko, 277-8577
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama, Ehime, Japonsko, 791-0280
- NHO Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japonsko, 811-1395
- National Hospital Organization Kyushu Cancer Center
-
-
Fukushima
-
Fukushima, Fukushima, Japonsko, 960-1295
- Fukushima Medical University Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japonsko, 003-0804
- National Hospital Organization Hokkaido Cancer Center
-
-
Ibaraki
-
Tsukuba, Ibaraki, Japonsko, 305-8576
- University of Tsukuba Hospital
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, Japonsko, 920-8530
- Ishikawa Prefectural Central Hospital
-
-
Kanagawa
-
Yokohama, Kanagawa, Japonsko, 241-8515
- Kanagawa Cancer Center
-
-
Okinawa
-
Naha, Okinawa, Japonsko, 901-0154
- Naha Nishi Clinic
-
-
Osaka
-
Osakasayama-shi, Osaka, Japonsko, 589-8511
- Kindai University Hospital
-
Sakai, Osaka, Japonsko, 590-0197
- Kindai University Hospital
-
-
Tokyo
-
Chuo-ku, Tokyo, Japonsko, 104-0045
- National Cancer Center Hospital
-
Chuo-ku, Tokyo, Japonsko, 104-8560
- St. Luke's International Hospital.
-
Minato-ku, Tokyo, Japonsko, 105-8470
- Toranomon Hospital
-
Shinagawa-ku, Tokyo, Japonsko, 142-8666
- Showa University Hospital
-
-
-
-
-
Busan, Jižní Korea, 49201
- Dong-A University Hospital
-
Incheon, Jižní Korea, 21565
- Gachon University Gil Medical Center
-
Seoul, Jižní Korea, 02841
- Korea University Anam Hospital
-
-
Gangwon-do
-
Wŏnju, Gangwon-do, Jižní Korea, 26426
- Yonsei University Wonju Severance Christian Hospital
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Jižní Korea, 10408
- National Cancer Center
-
Seongnam-si, Gyeonggi-do, Jižní Korea, 13620
- Seoul National University Bundang Hospital
-
Suwon, Gyeonggi-do, Jižní Korea, 16247
- The Catholic University of Korea, St. Vincent's Hospital
-
Suwon, Gyeonggi-do, Jižní Korea, 16499
- Ajou University Hospital
-
-
North Chungcheong
-
Cheongju-si, North Chungcheong, Jižní Korea, 28644
- Chungbuk Nationl University Hospital
-
-
Other
-
Seoul, Other, Jižní Korea, 03080
- Seoul National University Hospital
-
Seoul, Other, Jižní Korea, 05505
- Asan Medical Center
-
Seoul, Other, Jižní Korea, 06273
- Gangnam Severance Hospital, Yonsei University Health System
-
Seoul, Other, Jižní Korea, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul, Other, Jižní Korea, 07985
- Ewha Womans University Mokdong Hospital
-
-
Seoul-teukbyeolsi [seoul]
-
Seoul, Seoul-teukbyeolsi [seoul], Jižní Korea, 03722
- Severance Hospital Yonsei University Health System
-
-
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G 1Z2
- Cross Cancer Institute
-
-
British Columbia
-
Kelowna, British Columbia, Kanada, V1Y 5L3
- BC Cancer Agency
-
-
Ontario
-
Ottawa, Ontario, Kanada, K1H 8L6
- The Ottawa Hospital Cancer Centre
-
Toronto, Ontario, Kanada, M5G 1X5
- Mount Sinai Hospital
-
Toronto, Ontario, Kanada, M4N 3M5
- Sunnybrook Research Institute
-
-
Quebec
-
Chicoutimi, Quebec, Kanada, G7H 5H6
- Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
-
Montreal, Quebec, Kanada, H3T 1E2
- Jewish General Hospital
-
Montreal, Quebec, Kanada, H2X 3E4
- Centre Hospitalier de l'Universite de Motreal (CHUM)
-
-
-
-
-
Augsburg, Německo, 86156
- "Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe"
-
Berlin, Německo, 10117
- Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum
-
Berlin, Německo, 13353
- Charite - Universitatsmedizin Berlin
-
Hamburg, Německo, 20246
- Universitatsklinikum Hamburg-Eppendorf (UKE)
-
München, Německo, 81675
- Klinik und Poliklinik fur Frauenheilkunde der Technischen Universitat Munchen
-
Ulm, Německo, 89075
- Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe
-
Würzburg, Německo, 97080
- Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
-
Würzburg, Německo, 97080
- Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF)
-
-
North Rhine-Westphalia
-
Münster, North Rhine-Westphalia, Německo, 48149
- University Hospital Muenster Senology
-
-
Other
-
Manheim, Other, Německo, 68167
- Universitätsmedizin Mannheim Universitätsfrauenklinik
-
Mannheim, Other, Německo, 68167
- Pharmacy:Fortuna Herstellung GmbH
-
-
-
-
-
Gdansk, Polsko, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Lodz, Polsko, 91-211
- Salve Medica
-
Lodz, Polsko, 91-211
- Salve Medica Apteka Szpitalna
-
Opole, Polsko, 45-061
- SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu
-
-
Other
-
Lodz, Other, Polsko, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
-
Silesian Voivodeship
-
Gliwice, Silesian Voivodeship, Polsko, 44-102
- Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy
-
-
-
-
-
Coimbra, Portugalsko, 3000-075
- Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
-
Lisbon, Portugalsko, 1400-038
- Fundacao Champalimaud
-
-
Other
-
Braga, Other, Portugalsko, 4710-243
- Centro Clinico Academico Braga Hospital de Braga
-
Lisbon, Other, Portugalsko, 1998-018
- Hospital CUF Descobertas
-
-
-
-
-
Graz, Rakousko, A-8010
- Medizinische Universität Graz
-
Graz, Rakousko, A-8036
- Medizinische Universitat Graz
-
Linz, Rakousko, A-4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
-
Vienna, Rakousko, A-1090
- Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde
-
-
Other
-
Schwaz, Other, Rakousko, A-6130
- Ordination Priv.-Doz. Dr. Michael Hubalek
-
-
-
-
-
London, Spojené království, SW3 6JJ
- The Royal Marsden
-
London, Spojené království, N12 0JE
- Finchley Memorial Hospital
-
London, Spojené království, NW1 2PG
- University College London Hospital (UCLH) NHS Foundation Trust
-
Manchester, Spojené království, M20 4BX
- Christie Hospital NHS Foundation Trust
-
-
England
-
London, England, Spojené království, NW3 2QG
- Academic Oncology
-
-
Surrey
-
Sutton, Surrey, Spojené království, SM2 5PT
- The Royal Marsden
-
-
-
-
Arizona
-
Phoenix, Arizona, Spojené státy, 85054
- Mayo Clinic Hospital
-
Scottsdale, Arizona, Spojené státy, 85259
- Mayo Clinic
-
-
Arkansas
-
Little Rock, Arkansas, Spojené státy, 72205
- Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI
-
-
California
-
Beverly Hills, California, Spojené státy, 90212
- UCLA Hematology/Oncology - Beverly Hills
-
Burbank, California, Spojené státy, 91505
- UCLA Hematology/Oncology - Burbank
-
Encinitas, California, Spojené státy, 92024
- UCSD Medical Center - Encinitas
-
La Jolla, California, Spojené státy, 92093
- UC San Diego Moores Cancer Center
-
La Jolla, California, Spojené státy, 92037
- Sulpizio Cardiovascular Center at UC San Diego Health
-
La Jolla, California, Spojené státy, 92037
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
-
La Jolla, California, Spojené státy, 92037
- UCSD Perlman Medical Offices
-
La Jolla, California, Spojené státy, 92037
- UCSD Koman Family Outpatient Pavilion
-
Laguna Hills, California, Spojené státy, 92653
- UCLA Hematology/Oncology - Laguna Hills
-
Los Angeles, California, Spojené státy, 90095
- UCLA Hematology/Oncology
-
Los Angeles, California, Spojené státy, 90095
- Administrative Address: UCLA Hematology/Oncology
-
San Diego, California, Spojené státy, 92103
- UC San Diego Medical Center - Hillcrest
-
San Diego, California, Spojené státy, 912101
- UCSD Medical Center - Bankers Hill
-
San Luis Obispo, California, Spojené státy, 93401
- UCLA Hematology/Oncology - San Luis Obispo
-
Santa Barbara, California, Spojené státy, 93101
- UCLA Hematology/Oncology- Santa Barbara
-
Santa Monica, California, Spojené státy, 90404
- UCLA Hematology/Oncology - Santa Monica
-
Santa Monica, California, Spojené státy, 90404
- UCLA Hematology/Oncology Parkside
-
Torrance, California, Spojené státy, 90509
- Harbor-UCLA Medical Center
-
Torrance, California, Spojené státy, 90502
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
-
Torrance, California, Spojené státy, 90502
- Clinical And Translational Research Center
-
Valencia, California, Spojené státy, 91355
- UCLA Hematology/Oncology - Santa Clarita
-
Vista, California, Spojené státy, 92081
- UCSD Medical Center - Vista
-
Westlake Village, California, Spojené státy, 91361
- UCLA Hematology/Oncology- Westlake
-
-
Florida
-
Altamonte Springs, Florida, Spojené státy, 32701
- AdventHealth Altamonte Infusion Center
-
Altamonte Springs, Florida, Spojené státy, 32701
- AdventHealth Medical Group Altamonte(second location)
-
Altamonte Springs, Florida, Spojené státy, 32701
- AdventHealth Medical Group Altamonte
-
Jacksonville, Florida, Spojené státy, 32224
- Mayo Clinic Florida
-
Orlando, Florida, Spojené státy, 32804
- AdventHealth Orlando Infusion Center
-
Orlando, Florida, Spojené státy, 32804
- AdventHealth Medical Group Orlando
-
-
Georgia
-
Atlanta, Georgia, Spojené státy, 30308
- Emory University Hospital Midtown
-
Atlanta, Georgia, Spojené státy, 30342
- Emory Saint Joseph's Hospital
-
Atlanta, Georgia, Spojené státy, 30322
- Winship Cancer Institute
-
Atlanta, Georgia, Spojené státy, 30322
- Emory University Clinic
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60612
- University of Illinois Hospital and Health Systems
-
Chicago, Illinois, Spojené státy, 60612
- University of Illinois Hospital and Health Systems (Outpatient Cancer Center)
-
Chicago, Illinois, Spojené státy, 60612
- University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy)
-
-
Kentucky
-
Louisville, Kentucky, Spojené státy, 40207
- Norton Cancer Institute, St. Matthews Campus
-
Louisville, Kentucky, Spojené státy, 40207
- Norton Cancer Institute, St Matthews Campus
-
Louisville, Kentucky, Spojené státy, 40241
- Norton Cancer Institute, Brownsboro Hospital Campus
-
Louisville, Kentucky, Spojené státy, 40202
- Norton Cancer Institute, Downtown
-
Louisville, Kentucky, Spojené státy, 40202
- Norton Cancer Institute - Downtown
-
-
Maryland
-
Baltimore, Maryland, Spojené státy, 21202
- Mercy Medical Center
-
-
Minnesota
-
Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic
-
-
Missouri
-
Kansas City, Missouri, Spojené státy, 64111
- Saint Luke's Cancer Institute.
-
-
Nebraska
-
Grand Island, Nebraska, Spojené státy, 68803
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
-
Grand Island, Nebraska, Spojené státy, 68803
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, Spojené státy, 68130
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, Spojené státy, 68124
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, Spojené státy, 68114
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Papillion, Nebraska, Spojené státy, 68046
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
-
New Jersey
-
Jersey City, New Jersey, Spojené státy, 07302
- RWJBarnabas Health- Jersey City Medical Center
-
Lakewood, New Jersey, Spojené státy, 08701
- RWJBarnabas Health- Monmouth Medical Center-Southern Campus
-
Livingston, New Jersey, Spojené státy, 07039
- RWJBarnabas Health- Cooperman Barnabas Medical Center
-
Long Branch, New Jersey, Spojené státy, 07740
- RWJBarnabas Health- Monmouth Medical Center
-
New Brunswick, New Jersey, Spojené státy, 08903
- Rutgers Cancer Institute of New Jersey
-
Newark, New Jersey, Spojené státy, 07112
- Newark Beth Israel Medical Center
-
Somerville, New Jersey, Spojené státy, 08876
- Steeplechase Cancer Center
-
Somerville, New Jersey, Spojené státy, 08876
- RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset
-
Toms River, New Jersey, Spojené státy, 08755
- RWJBarnabas Health - Community Medical Center
-
West Long Branch, New Jersey, Spojené státy, 07764
- Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center
-
-
New York
-
The Bronx, New York, Spojené státy, 10461
- Montefiore Einstein Comprehensive Cancer Center
-
-
Ohio
-
Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic
-
Cleveland, Ohio, Spojené státy, 44106
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
-
Strongsville, Ohio, Spojené státy, 44136
- Cleveland Clinic Cancer Center - Strongsville
-
-
Pennsylvania
-
Willow Grove, Pennsylvania, Spojené státy, 19090
- Asplundh Cancer Pavillion
-
-
Tennessee
-
Gallatin, Tennessee, Spojené státy, 37066
- Tennessee Oncology, PLLC
-
Murfreesboro, Tennessee, Spojené státy, 37129
- Tennessee Oncology, PLLC
-
Nashville, Tennessee, Spojené státy, 37203
- Tennessee Oncology, PLLC
-
Nashville, Tennessee, Spojené státy, 37203
- Sarah Cannon Research Institute- Pharmacy
-
Shelbyville, Tennessee, Spojené státy, 37160
- Tennessee Oncology, PLLC
-
-
Washington
-
Seattle, Washington, Spojené státy, 98195
- University of Washington Medical Center
-
Seattle, Washington, Spojené státy, 98109
- Fred Hutchinson Cancer Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, Spojené státy, 53226
- Froedtert Hospital/Medical College of Wisconsin
-
-
-
-
-
Changhua, Tchaj-wan, 500 (R.O.C.)
- Changhua Christian Medical Foundation Changhua Christian Hospital
-
Kaohsiung City, Tchaj-wan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
New Taipei City, Tchaj-wan, 23561 (R.O.C.)
- Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
-
New Taipei City, Tchaj-wan, 23561 (R.O.C)
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
-
Taichung, Tchaj-wan, 40447 (R.O.C.)
- China Medical University Hospital
-
Taipei, Tchaj-wan, 11217
- Taipei Veterans General Hospital
-
Taipei, Tchaj-wan, 11490, R.O.C.
- Tri-Service General Hospital
-
Taoyuan City, Tchaj-wan, 333
- Chang Gung Memorial Hospital LinKou
-
-
Other
-
Tainan, Other, Tchaj-wan, 704
- National Cheng Kung University Hospital
-
Taipei, Other, Tchaj-wan, 10449
- MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
-
Taipei, Other, Tchaj-wan, 112
- Koo Foundation Sun Yat-Sen Cancer Center
-
-
R.o.c
-
Taipei, R.o.c, Tchaj-wan, 100
- National Taiwan University Hospital
-
-
Tainan
-
Tainan, Tainan, Tchaj-wan, 710
- Chi Mei Medical Center
-
-
-
-
-
Brno, Česko, 656 53
- Masarykuv Onkologicky Ustav
-
Prague, Česko, 128 08
- Vseobecna fakultni nemocnice v Praze
-
Praha 5 - Motol, Česko, 15006
- Nemocnicni lekarna Fakultni nemocnice v Motole
-
Praha 5 - Motol, Česko, 15006
- Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol
-
-
Other
-
Brno, Other, Česko, 656 53
- Ustavni lekarna Masarykuv onkologicky ustav
-
Praha 4 - Krc, Other, Česko, 14059
- Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN
-
-
-
-
-
Beijing, Čína, 100730
- Beijing Hospital
-
Beijing, Čína, 100010
- Beijing Hospital
-
Shanghai, Čína, 200032
- Fudan University Shanghai Cancer Center
-
Tianjin, Čína, 300181
- Tianjin Cancer Hospital Binhai Campus
-
-
Anhui
-
Hefei, Anhui, Čína, 230601
- The Second Hospital of Anhui Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, Čína, 510080
- Guangdong Provincial People's Hospital
-
Meizhou, Guangdong, Čína, 514031
- Meizhou People's Hospital
-
-
Guangxi
-
Liuzhou, Guangxi, Čína, 545006
- Liuzhou People's Hospital
-
Nanning, Guangxi, Čína, 530021
- The People's Hospital of Guangxi Zhuang Autonomous Region
-
Nanning, Guangxi, Čína, 530021
- Guangxi Medical University Affiliated Tumor Hospital
-
-
Hainan
-
Haikou, Hainan, Čína, 570102
- The first Affiliated Hospital of Hainan Medical University
-
-
Hebei
-
Baoding, Hebei, Čína, 071000
- Affiliated Hospital of Hebei University
-
-
Henan
-
Zhengzhou, Henan, Čína, 450003
- Henan Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, Čína, 430079
- Hubei Cancer Hospital
-
Wuhan, Hubei, Čína, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
-
-
Hunan
-
Changsha, Hunan, Čína, 410011
- The Second Xiangya Hospital of Central South University
-
-
Jiangsu
-
Nanjing, Jiangsu, Čína, 210036
- Nanjing Medical University (NMU) - Jiangsu Province Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, Čína, 330008
- The Second Affiliated Hospital of Nanchang University
-
-
Jilin
-
Changchun, Jilin, Čína, 130021
- The First Hospital of Jilin University
-
-
Liaoning
-
Shenyang, Liaoning, Čína, 110042
- Liaoning Cancer Hospital & Insitute
-
Shenyang, Liaoning, Čína, 110167
- The First Affiliated Hospital of China Medical University
-
-
Other
-
Shanghai, Other, Čína, 200025
- Ruijin Hospital of Shanghai Jiaotong University School of Medicine
-
-
Shaanxi
-
Xi'an, Shaanxi, Čína, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Xi'an, Shaanxi, Čína, 710068
- Shaanxi Provincial People's Hospital
-
-
Shandong
-
Jinan, Shandong, Čína, 250013
- Jinan Central Hospital
-
Linyi, Shandong, Čína, 276034
- Linyi Cancer Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, Čína, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, Čína, 310005
- Zhejiang Cancer Hospital
-
Hangzhou, Zhejiang, Čína, 310052
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
-
-
-
-
Larissa, Řecko, 41110
- University General Hospital of Larissa, Oncology Clinic
-
Marousi, Řecko, 15123
- IASO General Clinic Oncology Clinic
-
Pireaus, Řecko, 18537
- Metaxa Anticancer Hospital of Piraeus
-
-
Attica
-
Athens, Attica, Řecko, 11528
- General Hospital of Athens "Alexandra" Clinical Therapeutics Department, Hematology/Oncology Unit
-
-
Peloponnese
-
Patra, Peloponnese, Řecko, 26504
- University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
-
-
-
-
-
Barcelona, Španělsko, 08035
- Hospital Universitari Vall d'Hebron
-
Barcelona, Španělsko, 08035
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
-
Barcelona, Španělsko, 08025
- Fundacio de Gestio Sanitaria de I'Hospital de la Santa Creu i Sant Pau
-
Barcelona, Španělsko, 08041
- Hospital de la Santa Creu i Sant Pau
-
Bilbao, Španělsko, 48013
- Hospital Universitario de Basurto
-
Girona, Španělsko, 17007
- Institut Catala d'Oncologia Girona - ICO Girona
-
Granada, Španělsko, 18014
- Hospital Universitario Virgen de las Nieves
-
Lleida, Španělsko, 25198
- Hospital Universitari Arnau de Vilanova
-
Madrid, Španělsko, 28007
- Hospital General Universitario Gregorio Maranon
-
Málaga, Španělsko, 29010
- Hospital Universitario Virgen de la Victoria
-
Salamanca, Španělsko, 37007
- Hospital Universitario de Salamanca (Spain Salamanca)
-
Seville, Španělsko, 41013
- Hospital Universitario Virgen del Rocio
-
Valencia, Španělsko, 46009
- Fundacion lnstituto Valenciano de Oncologia
-
-
Andalusia
-
Málaga, Andalusia, Španělsko, 29016
- Hospital El Angel Grupo Hla, S.L.U
-
-
Balearic Islands
-
Palma de Mallorca, Balearic Islands, Španělsko, 07120
- Hospital Universitario Son Espases
-
-
Murcia
-
EI Palmar, Murcia, Španělsko, 30120
- Hospital Universitario Virgen De La Arrixaca
-
-
Other
-
Barcelona, Other, Španělsko, 08035
- Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
-
Cáceres, Other, Španělsko, 10003
- Hospital San Pedro de Alcantara
-
Madrid, Other, Španělsko, 28034
- Hospital Universitario Ramon y Cajal
-
Valencia, Other, Španělsko, 46010
- Hospital Clinico Universitario de Valencia
-
-
Santa CRUZ DE Tenerife
-
La Laguna Tenerife, Santa CRUZ DE Tenerife, Španělsko, 38320
- Hospital Universitario de Canarias
-
-
Valencia
-
Alicante, Valencia, Španělsko, 03010
- Hospital General Universitario Alicante
-
-
-
-
-
Baden, Švýcarsko, 5404
- Kantonsspital Baden.
-
Zurich, Švýcarsko, 8008
- Brust-Zentrum AG
-
-
Canton of Zurich
-
Winterthur, Canton of Zurich, Švýcarsko, 8401
- Kantonsspital Winterthur
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: Tucatinib + trastuzumab + pertuzumab
Tucatinib + trastuzumab + pertuzumab |
300mg given by mouth (orally) twice daily
Ostatní jména:
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
Ostatní jména:
420mg given by IV every 21 days
Ostatní jména:
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.
Ostatní jména:
|
|
Aktivní komparátor: 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
Ostatní jména:
420mg given by IV every 21 days
Ostatní jména:
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.
Ostatní jména:
Given orally twice daily |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Časové okno: 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)
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival (OS)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants With TEAEs: Through Study Completion
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Kožní choroby
- Nemoci prsu
- Onemocnění kůže a pojivové tkáně
- Novotvary prsu
- Aminokyseliny, peptidy a proteiny
- Proteiny
- Protilátky, monoklonální, humanizované
- Protilátky, monoklonální
- Protilátky
- Imunoglobuliny
- Imunoproteiny
- Krevní proteiny
- Sérové globuliny
- Globuliny
- Trastuzumab
- pertuzumab
- Tucatinib
Další identifikační čísla studie
Další identifikační čísla studie
- SGNTUC-028
- C4251007 (Jiný identifikátor: Alias Study Number)
- 2023-503826-37-00 (Identifikátor registru: CTIS (EU))
- 2023 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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