Badanie tucatinibu lub placebo z trastuzumabem i pertuzumabem w przerzutowym raku piersi HER2+ (HER2CLIMB-05)
Randomizowane, podwójnie zaślepione badanie fazy 3 dotyczące stosowania tucatynibu lub placebo w skojarzeniu z trastuzumabem i pertuzumabem jako terapii podtrzymującej raka piersi HER2+ z przerzutami (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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
-
-
New South Wales
-
Camperdown, New South Wales, Australia, 2050
- Chris O'Brien Lifehouse
-
Macquarie University, New South Wales, Australia, 2109
- Macquarie University Clinical Trials Unit.
-
Westmead, New South Wales, Australia, 2145
- Western Sydney Local Health District (WSLHD), Westmead Hospital
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- Cancer Research SA
-
Adelaide, South Australia, Australia, 5000
- St Andrews Medical Centre
-
Bedford Park, South Australia, Australia, 5042
- Flinders Medical Centre
-
-
Victoria
-
Box Hill, Victoria, Australia, 3128
- Box Hill Hospital
-
Heidelberg, Victoria, Australia, 3084
- Austin Health
-
-
Washington
-
Subiaco, Washington, Australia, 6008
- St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre
-
-
-
-
-
Graz, Austria, A-8010
- Medizinische Universität Graz
-
Graz, Austria, A-8036
- Medizinische Universitat Graz
-
Linz, Austria, A-4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
-
Vienna, Austria, A-1090
- Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde
-
-
Other
-
Schwaz, Other, Austria, A-6130
- Ordination Priv.-Doz. Dr. Michael Hubalek
-
-
-
-
-
Anderlecht, Belgia, 1070
- Jules Bordet lnstituut
-
Brussels, Belgia, 1090
- Universitair Ziekenhuis Brussel (UZ Brussel)
-
Brussels, Belgia, 1200
- Cliniques Universitaires Saint-Luc
-
Ottignies, Belgia, 1340
- Clinique St-Pierre
-
-
-
-
-
Porto Alegre/RS, Brazylia, 90050-170
- Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica
-
São José do Rio Preto, Brazylia, 15090-000
- Faculdade Regional de Medicina de Sao Jose do Rio Preto
-
São Paulo, Brazylia, 01246-000
- ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
-
São Paulo, Brazylia, 04014-002
- Sao Camilo Oncologia
-
São Paulo, Brazylia, CEP: 01317-000
- Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
-
-
Ceará
-
Fortaleza, Ceará, Brazylia, 60336-232
- CRIO - Centro Regional lntegrado de Oncologia
-
-
Goiás
-
Goiânia, Goiás, Brazylia, 74605-070
- Hospital Araujo Jorge
-
-
Other
-
Sao Paulo/SP, Other, Brazylia, 01.509-010
- A.C. Camargo Câncer Center
-
-
Paraná
-
Londrina, Paraná, Brazylia, 86015-520
- Hospital Do Cancer De Londrina
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Brazylia, 59075-740
- Liga Norte-Rio Grandense Contra o Cancer
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazylia, 90035-903
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre, Rio Grande do Sul, Brazylia, CEP 90110-270
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
-
Porto Alegre, Rio Grande do Sul, Brazylia, CEP 90850-170
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
-
-
São Paulo
-
Barretos, São Paulo, Brazylia, CEP: 14784-400
- Fundacao Pio XII, Hospital do Amor de Barretos
-
Jaú, São Paulo, Brazylia, CEP: 17210-080
- Fundacao Dr Amaral Carvalho
-
Santo André, São Paulo, Brazylia, 09060-650
- CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia
-
Santo André, São Paulo, Brazylia, 09060-870
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
-
-
-
-
-
Talca, Chile, 3460000
- Clinica Universidad Catolica del Maule
-
Temuco, Chile, 4810297
- Clinica Alemana Temuco
-
Temuco, Chile, 4810469
- James Lind Centro De Investigacion Del Cancer
-
-
Santiago Metropolitan
-
Recoleta, Santiago Metropolitan, Chile, 8420323
- Centro de Investigacion Clínica Bradford Hill
-
-
Valparaiso
-
Viña del Mar, Valparaiso, Chile
- Oncocentro Apys
-
-
-
-
-
Beijing, Chiny, 100730
- Beijing Hospital
-
Beijing, Chiny, 100010
- Beijing Hospital
-
Shanghai, Chiny, 200032
- Fudan University Shanghai Cancer Center
-
Tianjin, Chiny, 300181
- Tianjin Cancer Hospital Binhai Campus
-
-
Anhui
-
Hefei, Anhui, Chiny, 230601
- The Second Hospital of Anhui Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, Chiny, 510080
- Guangdong Provincial People's Hospital
-
Meizhou, Guangdong, Chiny, 514031
- Meizhou People's Hospital
-
-
Guangxi
-
Liuzhou, Guangxi, Chiny, 545006
- Liuzhou People's Hospital
-
Nanning, Guangxi, Chiny, 530021
- The People's Hospital of Guangxi Zhuang Autonomous Region
-
Nanning, Guangxi, Chiny, 530021
- Guangxi Medical University Affiliated Tumor Hospital
-
-
Hainan
-
Haikou, Hainan, Chiny, 570102
- The first Affiliated Hospital of Hainan Medical University
-
-
Hebei
-
Baoding, Hebei, Chiny, 071000
- Affiliated Hospital of Hebei University
-
-
Henan
-
Zhengzhou, Henan, Chiny, 450003
- Henan Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, Chiny, 430079
- Hubei Cancer Hospital
-
Wuhan, Hubei, Chiny, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
-
-
Hunan
-
Changsha, Hunan, Chiny, 410011
- The Second Xiangya Hospital of Central South University
-
-
Jiangsu
-
Nanjing, Jiangsu, Chiny, 210036
- Nanjing Medical University (NMU) - Jiangsu Province Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, Chiny, 330008
- The Second Affiliated Hospital of Nanchang University
-
-
Jilin
-
Changchun, Jilin, Chiny, 130021
- The First Hospital of Jilin University
-
-
Liaoning
-
Shenyang, Liaoning, Chiny, 110042
- Liaoning Cancer Hospital & Insitute
-
Shenyang, Liaoning, Chiny, 110167
- The First Affiliated Hospital of China Medical University
-
-
Other
-
Shanghai, Other, Chiny, 200025
- Ruijin Hospital of Shanghai Jiaotong University School of Medicine
-
-
Shaanxi
-
Xi'an, Shaanxi, Chiny, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Xi'an, Shaanxi, Chiny, 710068
- Shaanxi Provincial People's Hospital
-
-
Shandong
-
Jinan, Shandong, Chiny, 250013
- Jinan Central Hospital
-
Linyi, Shandong, Chiny, 276034
- Linyi Cancer Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, Chiny, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, Chiny, 310005
- Zhejiang Cancer Hospital
-
Hangzhou, Zhejiang, Chiny, 310052
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
-
-
-
-
Brno, Czechy, 656 53
- Masarykuv Onkologicky Ustav
-
Prague, Czechy, 128 08
- Vseobecna fakultni nemocnice v Praze
-
Praha 5 - Motol, Czechy, 15006
- Nemocnicni lekarna Fakultni nemocnice v Motole
-
Praha 5 - Motol, Czechy, 15006
- Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol
-
-
Other
-
Brno, Other, Czechy, 656 53
- Ustavni lekarna Masarykuv onkologicky ustav
-
Praha 4 - Krc, Other, Czechy, 14059
- Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN
-
-
-
-
-
Tampere, Finlandia
- Tampere University Hospital
-
Tampere, Finlandia, 33520
- Tampere University Hospital, FONK/RSYO
-
-
-
-
-
Besançon, Francja, 25000
- CHU Besancon
-
Bobigny, Francja, 93009 Cedex
- Hopital Avicenne
-
Caen, Francja, 14076 Cedex 5
- CENTRE FRANCOIS BACLESSE - Service lmagerie medicale
-
Caen, Francja, 14076
- Centre de Lutte contre le Cancer - François Baclesse
-
Caen, Francja, 14076 Cedex 5
- Centre Francois Baclesse
-
Clermont-Ferrand, Francja, 63000
- Centre Jean Perrin
-
Lille, Francja, 59020 Cedex
- Centre Oscar Lambret
-
Lyon, Francja, 69373 Cedex 08
- Center Leon Berard
-
Montpellier, Francja, 34298 Cedex 5
- Institut Regional du Cancer de Montpellier Service lmagerie medicale
-
Montpellier, Francja, 34298
- Institut Régional du Cancer de Montpellier
-
Nice, Francja, 06189
- Centre Antoine Lacassagne
-
Pierre-Bénite, Francja, 69310
- Hospices Civils de Lyon
-
Plérin, Francja, 22190
- "CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des
-
Rennes, Francja, cedex 35042
- Centre Eugene Marquis
-
Rouen, Francja, 76038 Cedex 1
- Centre Henri Becquerel
-
Saint-Cloud, Francja, 92210
- Institut Curie - site St-Cloud
-
Strasbourg, Francja, 67033
- Institut de Cancerologie Strasbourg Europe
-
-
Brittany Region
-
Rouen, Brittany Region, Francja, 76038
- Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
-
-
Cedex
-
Bordeaux, Cedex, Francja, 33076
- Institut Bergonie
-
-
Languedoc-roussillon
-
Montpellier, Languedoc-roussillon, Francja, 34070
- Centre de Cancérologie du Grand Montpellier
-
-
Loire-atlantique
-
Saint-Herblain, Loire-atlantique, Francja, 44800
- Institut de Cancerologie de lOuest - Site Rene Gauducheau
-
Saint-Herblain, Loire-atlantique, Francja, 44805
- Institut de Cancerologie de lOuest-Saint Herblain
-
-
Other
-
Avignon, Other, Francja, 84918
- Institut Sainte-Catherine.
-
Avignon, Other, Francja, 84918
- Sainte Catherine lnstitut du Cancer Avignon Provence
-
Dijon, Other, Francja, 21079
- Center Georges-Francois Leclerc
-
-
-
-
-
Larissa, Grecja, 41110
- University General Hospital of Larissa, Oncology Clinic
-
Marousi, Grecja, 15123
- IASO General Clinic Oncology Clinic
-
Pireaus, Grecja, 18537
- Metaxa Anticancer Hospital of Piraeus
-
-
Attica
-
Athens, Attica, Grecja, 11528
- General Hospital of Athens "Alexandra" Clinical Therapeutics Department, Hematology/Oncology Unit
-
-
Peloponnese
-
Patra, Peloponnese, Grecja, 26504
- University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
-
-
-
-
-
Barcelona, Hiszpania, 08035
- Hospital Universitari Vall d'Hebron
-
Barcelona, Hiszpania, 08035
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
-
Barcelona, Hiszpania, 08025
- Fundacio de Gestio Sanitaria de I'Hospital de la Santa Creu i Sant Pau
-
Barcelona, Hiszpania, 08041
- Hospital de la Santa Creu i Sant Pau
-
Bilbao, Hiszpania, 48013
- Hospital Universitario de Basurto
-
Girona, Hiszpania, 17007
- Institut Catala d'Oncologia Girona - ICO Girona
-
Granada, Hiszpania, 18014
- Hospital Universitario Virgen de las Nieves
-
Lleida, Hiszpania, 25198
- Hospital Universitari Arnau de Vilanova
-
Madrid, Hiszpania, 28007
- Hospital General Universitario Gregorio Maranon
-
Málaga, Hiszpania, 29010
- Hospital Universitario Virgen de la Victoria
-
Salamanca, Hiszpania, 37007
- Hospital Universitario de Salamanca (Spain Salamanca)
-
Seville, Hiszpania, 41013
- Hospital Universitario Virgen del Rocio
-
Valencia, Hiszpania, 46009
- Fundacion lnstituto Valenciano de Oncologia
-
-
Andalusia
-
Málaga, Andalusia, Hiszpania, 29016
- Hospital El Angel Grupo Hla, S.L.U
-
-
Balearic Islands
-
Palma de Mallorca, Balearic Islands, Hiszpania, 07120
- Hospital Universitario Son Espases
-
-
Murcia
-
EI Palmar, Murcia, Hiszpania, 30120
- Hospital Universitario Virgen De La Arrixaca
-
-
Other
-
Barcelona, Other, Hiszpania, 08035
- Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
-
Cáceres, Other, Hiszpania, 10003
- Hospital San Pedro de Alcantara
-
Madrid, Other, Hiszpania, 28034
- Hospital Universitario Ramon y Cajal
-
Valencia, Other, Hiszpania, 46010
- Hospital Clinico Universitario de Valencia
-
-
Santa CRUZ DE Tenerife
-
La Laguna Tenerife, Santa CRUZ DE Tenerife, Hiszpania, 38320
- Hospital Universitario de Canarias
-
-
Valencia
-
Alicante, Valencia, Hiszpania, 03010
- Hospital General Universitario Alicante
-
-
-
-
-
Dordrecht, Holandia, 3318 AT
- Albert Schweitzer Ziekenhuis
-
Utrecht, Holandia, 3543 AZ
- St. Antonius Hospital
-
Venlo, Holandia, 5912 BL
- VieCuri Medsich Centrum
-
-
South Holland
-
Doedrecht, South Holland, Holandia, 3318AT
- Albert Schweitzer Hospital
-
-
-
-
Chiba
-
Kamogawa, Chiba, Japonia, 296-8602
- Tesshokai Kameda General Hospital
-
Kashiwa-Shi, Chiba, Japonia, 277-8577
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama, Ehime, Japonia, 791-0280
- NHO Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japonia, 811-1395
- National Hospital Organization Kyushu Cancer Center
-
-
Fukushima
-
Fukushima, Fukushima, Japonia, 960-1295
- Fukushima Medical University Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japonia, 003-0804
- National Hospital Organization Hokkaido Cancer Center
-
-
Ibaraki
-
Tsukuba, Ibaraki, Japonia, 305-8576
- University of Tsukuba Hospital
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, Japonia, 920-8530
- Ishikawa Prefectural Central Hospital
-
-
Kanagawa
-
Yokohama, Kanagawa, Japonia, 241-8515
- Kanagawa Cancer Center
-
-
Okinawa
-
Naha, Okinawa, Japonia, 901-0154
- Naha Nishi Clinic
-
-
Osaka
-
Osakasayama-shi, Osaka, Japonia, 589-8511
- Kindai University Hospital
-
Sakai, Osaka, Japonia, 590-0197
- Kindai University Hospital
-
-
Tokyo
-
Chuo-ku, Tokyo, Japonia, 104-0045
- National Cancer Center Hospital
-
Chuo-ku, Tokyo, Japonia, 104-8560
- St. Luke's International Hospital.
-
Minato-ku, Tokyo, Japonia, 105-8470
- Toranomon Hospital
-
Shinagawa-ku, Tokyo, Japonia, 142-8666
- Showa University Hospital
-
-
-
-
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)
-
-
-
-
-
Busan, Korea Południowa, 49201
- Dong-A University Hospital
-
Incheon, Korea Południowa, 21565
- Gachon University Gil Medical Center
-
Seoul, Korea Południowa, 02841
- Korea University Anam Hospital
-
-
Gangwon-do
-
Wŏnju, Gangwon-do, Korea Południowa, 26426
- Yonsei University Wonju Severance Christian Hospital
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea Południowa, 10408
- National Cancer Center
-
Seongnam-si, Gyeonggi-do, Korea Południowa, 13620
- Seoul National University Bundang Hospital
-
Suwon, Gyeonggi-do, Korea Południowa, 16247
- The Catholic University of Korea, St. Vincent's Hospital
-
Suwon, Gyeonggi-do, Korea Południowa, 16499
- Ajou University Hospital
-
-
North Chungcheong
-
Cheongju-si, North Chungcheong, Korea Południowa, 28644
- Chungbuk Nationl University Hospital
-
-
Other
-
Seoul, Other, Korea Południowa, 03080
- Seoul National University Hospital
-
Seoul, Other, Korea Południowa, 05505
- Asan Medical Center
-
Seoul, Other, Korea Południowa, 06273
- Gangnam Severance Hospital, Yonsei University Health System
-
Seoul, Other, Korea Południowa, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul, Other, Korea Południowa, 07985
- Ewha Womans University Mokdong Hospital
-
-
Seoul-teukbyeolsi [seoul]
-
Seoul, Seoul-teukbyeolsi [seoul], Korea Południowa, 03722
- Severance Hospital Yonsei University Health System
-
-
-
-
-
Augsburg, Niemcy, 86156
- "Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe"
-
Berlin, Niemcy, 10117
- Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum
-
Berlin, Niemcy, 13353
- Charite - Universitatsmedizin Berlin
-
Hamburg, Niemcy, 20246
- Universitatsklinikum Hamburg-Eppendorf (UKE)
-
München, Niemcy, 81675
- Klinik und Poliklinik fur Frauenheilkunde der Technischen Universitat Munchen
-
Ulm, Niemcy, 89075
- Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe
-
Würzburg, Niemcy, 97080
- Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
-
Würzburg, Niemcy, 97080
- Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF)
-
-
North Rhine-Westphalia
-
Münster, North Rhine-Westphalia, Niemcy, 48149
- University Hospital Muenster Senology
-
-
Other
-
Manheim, Other, Niemcy, 68167
- Universitätsmedizin Mannheim Universitätsfrauenklinik
-
Mannheim, Other, Niemcy, 68167
- Pharmacy:Fortuna Herstellung GmbH
-
-
-
-
-
Gdansk, Polska, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Lodz, Polska, 91-211
- Salve Medica
-
Lodz, Polska, 91-211
- Salve Medica Apteka Szpitalna
-
Opole, Polska, 45-061
- SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu
-
-
Other
-
Lodz, Other, Polska, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
-
Silesian Voivodeship
-
Gliwice, Silesian Voivodeship, Polska, 44-102
- Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy
-
-
-
-
-
Coimbra, Portugalia, 3000-075
- Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
-
Lisbon, Portugalia, 1400-038
- Fundacao Champalimaud
-
-
Other
-
Braga, Other, Portugalia, 4710-243
- Centro Clinico Academico Braga Hospital de Braga
-
Lisbon, Other, Portugalia, 1998-018
- Hospital CUF Descobertas
-
-
-
-
Arizona
-
Phoenix, Arizona, Stany Zjednoczone, 85054
- Mayo Clinic Hospital
-
Scottsdale, Arizona, Stany Zjednoczone, 85259
- Mayo Clinic
-
-
Arkansas
-
Little Rock, Arkansas, Stany Zjednoczone, 72205
- Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI
-
-
California
-
Beverly Hills, California, Stany Zjednoczone, 90212
- UCLA Hematology/Oncology - Beverly Hills
-
Burbank, California, Stany Zjednoczone, 91505
- UCLA Hematology/Oncology - Burbank
-
Encinitas, California, Stany Zjednoczone, 92024
- UCSD Medical Center - Encinitas
-
La Jolla, California, Stany Zjednoczone, 92093
- UC San Diego Moores Cancer Center
-
La Jolla, California, Stany Zjednoczone, 92037
- Sulpizio Cardiovascular Center at UC San Diego Health
-
La Jolla, California, Stany Zjednoczone, 92037
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
-
La Jolla, California, Stany Zjednoczone, 92037
- UCSD Perlman Medical Offices
-
La Jolla, California, Stany Zjednoczone, 92037
- UCSD Koman Family Outpatient Pavilion
-
Laguna Hills, California, Stany Zjednoczone, 92653
- UCLA Hematology/Oncology - Laguna Hills
-
Los Angeles, California, Stany Zjednoczone, 90095
- UCLA Hematology/Oncology
-
Los Angeles, California, Stany Zjednoczone, 90095
- Administrative Address: UCLA Hematology/Oncology
-
San Diego, California, Stany Zjednoczone, 92103
- UC San Diego Medical Center - Hillcrest
-
San Diego, California, Stany Zjednoczone, 912101
- UCSD Medical Center - Bankers Hill
-
San Luis Obispo, California, Stany Zjednoczone, 93401
- UCLA Hematology/Oncology - San Luis Obispo
-
Santa Barbara, California, Stany Zjednoczone, 93101
- UCLA Hematology/Oncology- Santa Barbara
-
Santa Monica, California, Stany Zjednoczone, 90404
- UCLA Hematology/Oncology - Santa Monica
-
Santa Monica, California, Stany Zjednoczone, 90404
- UCLA Hematology/Oncology Parkside
-
Torrance, California, Stany Zjednoczone, 90509
- Harbor-UCLA Medical Center
-
Torrance, California, Stany Zjednoczone, 90502
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
-
Torrance, California, Stany Zjednoczone, 90502
- Clinical And Translational Research Center
-
Valencia, California, Stany Zjednoczone, 91355
- UCLA Hematology/Oncology - Santa Clarita
-
Vista, California, Stany Zjednoczone, 92081
- UCSD Medical Center - Vista
-
Westlake Village, California, Stany Zjednoczone, 91361
- UCLA Hematology/Oncology- Westlake
-
-
Florida
-
Altamonte Springs, Florida, Stany Zjednoczone, 32701
- AdventHealth Altamonte Infusion Center
-
Altamonte Springs, Florida, Stany Zjednoczone, 32701
- AdventHealth Medical Group Altamonte(second location)
-
Altamonte Springs, Florida, Stany Zjednoczone, 32701
- AdventHealth Medical Group Altamonte
-
Jacksonville, Florida, Stany Zjednoczone, 32224
- Mayo Clinic Florida
-
Orlando, Florida, Stany Zjednoczone, 32804
- AdventHealth Orlando Infusion Center
-
Orlando, Florida, Stany Zjednoczone, 32804
- AdventHealth Medical Group Orlando
-
-
Georgia
-
Atlanta, Georgia, Stany Zjednoczone, 30308
- Emory University Hospital Midtown
-
Atlanta, Georgia, Stany Zjednoczone, 30342
- Emory Saint Joseph's Hospital
-
Atlanta, Georgia, Stany Zjednoczone, 30322
- Winship Cancer Institute
-
Atlanta, Georgia, Stany Zjednoczone, 30322
- Emory University Clinic
-
-
Illinois
-
Chicago, Illinois, Stany Zjednoczone, 60612
- University of Illinois Hospital and Health Systems
-
Chicago, Illinois, Stany Zjednoczone, 60612
- University of Illinois Hospital and Health Systems (Outpatient Cancer Center)
-
Chicago, Illinois, Stany Zjednoczone, 60612
- University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy)
-
-
Kentucky
-
Louisville, Kentucky, Stany Zjednoczone, 40207
- Norton Cancer Institute, St. Matthews Campus
-
Louisville, Kentucky, Stany Zjednoczone, 40207
- Norton Cancer Institute, St Matthews Campus
-
Louisville, Kentucky, Stany Zjednoczone, 40241
- Norton Cancer Institute, Brownsboro Hospital Campus
-
Louisville, Kentucky, Stany Zjednoczone, 40202
- Norton Cancer Institute, Downtown
-
Louisville, Kentucky, Stany Zjednoczone, 40202
- Norton Cancer Institute - Downtown
-
-
Maryland
-
Baltimore, Maryland, Stany Zjednoczone, 21202
- Mercy Medical Center
-
-
Minnesota
-
Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic
-
-
Missouri
-
Kansas City, Missouri, Stany Zjednoczone, 64111
- Saint Luke's Cancer Institute.
-
-
Nebraska
-
Grand Island, Nebraska, Stany Zjednoczone, 68803
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
-
Grand Island, Nebraska, Stany Zjednoczone, 68803
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, Stany Zjednoczone, 68130
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, Stany Zjednoczone, 68124
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, Stany Zjednoczone, 68114
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Papillion, Nebraska, Stany Zjednoczone, 68046
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
-
New Jersey
-
Jersey City, New Jersey, Stany Zjednoczone, 07302
- RWJBarnabas Health- Jersey City Medical Center
-
Lakewood, New Jersey, Stany Zjednoczone, 08701
- RWJBarnabas Health- Monmouth Medical Center-Southern Campus
-
Livingston, New Jersey, Stany Zjednoczone, 07039
- RWJBarnabas Health- Cooperman Barnabas Medical Center
-
Long Branch, New Jersey, Stany Zjednoczone, 07740
- RWJBarnabas Health- Monmouth Medical Center
-
New Brunswick, New Jersey, Stany Zjednoczone, 08903
- Rutgers Cancer Institute of New Jersey
-
Newark, New Jersey, Stany Zjednoczone, 07112
- Newark Beth Israel Medical Center
-
Somerville, New Jersey, Stany Zjednoczone, 08876
- Steeplechase Cancer Center
-
Somerville, New Jersey, Stany Zjednoczone, 08876
- RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset
-
Toms River, New Jersey, Stany Zjednoczone, 08755
- RWJBarnabas Health - Community Medical Center
-
West Long Branch, New Jersey, Stany Zjednoczone, 07764
- Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center
-
-
New York
-
The Bronx, New York, Stany Zjednoczone, 10461
- Montefiore Einstein Comprehensive Cancer Center
-
-
Ohio
-
Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic
-
Cleveland, Ohio, Stany Zjednoczone, 44106
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
-
Strongsville, Ohio, Stany Zjednoczone, 44136
- Cleveland Clinic Cancer Center - Strongsville
-
-
Pennsylvania
-
Willow Grove, Pennsylvania, Stany Zjednoczone, 19090
- Asplundh Cancer Pavillion
-
-
Tennessee
-
Gallatin, Tennessee, Stany Zjednoczone, 37066
- Tennessee Oncology, PLLC
-
Murfreesboro, Tennessee, Stany Zjednoczone, 37129
- Tennessee Oncology, PLLC
-
Nashville, Tennessee, Stany Zjednoczone, 37203
- Tennessee Oncology, PLLC
-
Nashville, Tennessee, Stany Zjednoczone, 37203
- Sarah Cannon Research Institute- Pharmacy
-
Shelbyville, Tennessee, Stany Zjednoczone, 37160
- Tennessee Oncology, PLLC
-
-
Washington
-
Seattle, Washington, Stany Zjednoczone, 98195
- University of Washington Medical Center
-
Seattle, Washington, Stany Zjednoczone, 98109
- Fred Hutchinson Cancer Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Froedtert Hospital/Medical College of Wisconsin
-
-
-
-
-
Baden, Szwajcaria, 5404
- Kantonsspital Baden.
-
Zurich, Szwajcaria, 8008
- Brust-Zentrum AG
-
-
Canton of Zurich
-
Winterthur, Canton of Zurich, Szwajcaria, 8401
- Kantonsspital Winterthur
-
-
-
-
-
Changhua, Tajwan, 500 (R.O.C.)
- Changhua Christian Medical Foundation Changhua Christian Hospital
-
Kaohsiung City, Tajwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
New Taipei City, Tajwan, 23561 (R.O.C.)
- Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
-
New Taipei City, Tajwan, 23561 (R.O.C)
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
-
Taichung, Tajwan, 40447 (R.O.C.)
- China Medical University Hospital
-
Taipei, Tajwan, 11217
- Taipei Veterans General Hospital
-
Taipei, Tajwan, 11490, R.O.C.
- Tri-Service General Hospital
-
Taoyuan City, Tajwan, 333
- Chang Gung Memorial Hospital LinKou
-
-
Other
-
Tainan, Other, Tajwan, 704
- National Cheng Kung University Hospital
-
Taipei, Other, Tajwan, 10449
- MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
-
Taipei, Other, Tajwan, 112
- Koo Foundation Sun Yat-Sen Cancer Center
-
-
R.o.c
-
Taipei, R.o.c, Tajwan, 100
- National Taiwan University Hospital
-
-
Tainan
-
Tainan, Tainan, Tajwan, 710
- Chi Mei Medical Center
-
-
-
-
-
Bologna, Włochy, 40138
- Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
-
Bologna, Włochy, 40138
- SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi
-
Milan, Włochy, 20089
- Istituto Clinico Humanitas
-
Milan, Włochy, 20141
- Divisione di Senologia Medica; Istituto Europeo di Oncologia
-
Parma, Włochy, 43126
- UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma
-
Pavia, Włochy, 27100
- Istituti Clinici Scientifici Maugeri IRCCS
-
-
Campania
-
Naples, Campania, Włochy, 80131
- Azienda Ospedaliera Universitaria Federico II
-
Naples, Campania, Włochy, 80131
- lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica
-
-
Liguria
-
Genoa, Liguria, Włochy, 16132
- IRCCS Ospedale Policlinico, San Martino
-
-
Lombardy
-
Monza (MB), Lombardy, Włochy, 20900
- ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1
-
-
Sicily
-
Catania (CT), Sicily, Włochy, 95045
- Humanitas lstituto Clinico Catanese
-
-
The Marches
-
Torrette, The Marches, Włochy, 60126
- Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica
-
-
Trentino-Alto Adige
-
Trento, Trentino-Alto Adige, Włochy, 38122
- Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara
-
Trento, Trentino-Alto Adige, Włochy, 38122
- SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO)
-
-
Tuscany
-
Livorno, Tuscany, Włochy, 57124
- Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor
-
Prato, Tuscany, Włochy, 59100
- S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano
-
-
-
-
-
London, Zjednoczone Królestwo, SW3 6JJ
- The Royal Marsden
-
London, Zjednoczone Królestwo, N12 0JE
- Finchley Memorial Hospital
-
London, Zjednoczone Królestwo, NW1 2PG
- University College London Hospital (UCLH) NHS Foundation Trust
-
Manchester, Zjednoczone Królestwo, M20 4BX
- Christie Hospital NHS Foundation Trust
-
-
England
-
London, England, Zjednoczone Królestwo, NW3 2QG
- Academic Oncology
-
-
Surrey
-
Sutton, Surrey, Zjednoczone Królestwo, SM2 5PT
- The Royal Marsden
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Tucatinib + trastuzumab + pertuzumab
Tucatinib + trastuzumab + pertuzumab |
300mg given by mouth (orally) twice daily
Inne nazwy:
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
Inne nazwy:
420mg given by IV every 21 days
Inne nazwy:
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.
Inne nazwy:
|
|
Aktywny komparator: 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
Inne nazwy:
420mg given by IV every 21 days
Inne nazwy:
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.
Inne nazwy:
Given orally twice daily |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Overall Survival (OS)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants With TEAEs: Through Study Completion
Ramy czasowe: 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)
|
Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Pfizer CT.gov Call Center, Pfizer
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory według lokalizacji
- Nowotwory
- Choroby skórne
- Choroby piersi
- Choroby skóry i tkanki łącznej
- Nowotwory piersi
- Aminokwasy, peptydy i białka
- Białka
- Przeciwciała, monoklonalne, humanizowane
- Przeciwciała, monoklonalne
- Przeciwciała
- Immunoglobuliny
- Immunoproteiny
- Białka krwi
- Globuliny w surowicy
- Globuliny
- Trastuzumab
- pertuzumab
- Tukatynib
Inne numery identyfikacyjne badania
- SGNTUC-028
- C4251007 (Inny identyfikator: Alias Study Number)
- 2023-503826-37-00 (Identyfikator rejestru: CTIS (EU))
- 2023 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .