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JOURNAL ONKOLOGIE – STUDIE
HER2CLIMB-05

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Rekrutierend

NCT-Nummer:
NCT05132582

Studienbeginn:
März 2022

Letztes Update:
23.04.2024

Wirkstoff:
Tucatinib, Trastuzumab, Pertuzumab, Combination product: Trastuzumab + Pertuzumab, Placebo

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Seagen Inc.

Collaborator:
Merck Sharp & Dohme LLC

Studienleiter

Medical Monitor
Study Director
Seagen Inc.

Kontakt

Studienlocations
(3 von 291)

Universitatsklinikum Augsburg
86156 Augsburg
(Bayern)
GermanyRekrutierend» Google-Maps
Charite Universitatsmedizin Berlin
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Dusseldorf
40225 Dusseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Erlangen
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum Esslingen GmbH
73730 Esslingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Hamburg-Eppendorf (UKE)
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
DeutschlandRekrutierend» Google-Maps
St. Elisabeth-Krankenhaus Koln-Hohenlind
50935 Koln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Schleswig-Holstein - Campus Lubeck
23538 Lubeck
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Medical Faculty Mannheim, Heidelberg University
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Klinikum Rechts der Isar der Technischen Universitaet Muenchen
81675 München
(Bayern)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Muenster
48149 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitatsklinik Tuebingen
72076 Tubingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Uniklinikum Wurzburg
97080 Wurzburg
(Bayern)
GermanyRekrutierend» Google-Maps
Krankenhaus St. Josef
93053 Regensburg
(Bayern)
GermanyRekrutierend» Google-Maps
CARTI Cancer Center
72205 Little Rock
United StatesRekrutierend» Google-Maps
UCLA Department of Medicine - Hematology & Oncology
90404 Santa Monica
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Nicholas P McAndrew
Phone: 310-980-6537
E-Mail: nmcandrew@mednet.ucla.edu
» Ansprechpartner anzeigen
Winship Cancer Institute / Emory University School of Medicine
30322 Atlanta
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jane L Meisel
Phone: 404-778-1900
E-Mail: jane.l.meisel@emory.edu
» Ansprechpartner anzeigen
Kaiser Permanente Moanalua Medical Center
96819 Honolulu
United StatesAbgeschlossen» Google-Maps
Norton Cancer Institute
40202 Louisville
United StatesRekrutierend» Google-Maps
Norton Cancer Institute
40207 Louisville
United StatesRekrutierend» Google-Maps
Nebraska Cancer Specialists
68803 Grand Island
United StatesRekrutierend» Google-Maps
Rutgers Cancer Institute of New Jersey
07302 Jersey City
United StatesRekrutierend» Google-Maps
Monmouth Medical Center Southern Campus
08701 Lakewood
United StatesRekrutierend» Google-Maps
Saint Barnabas Medical Center Cancer Center
07039 Livingston
United StatesRekrutierend» Google-Maps
Monmouth Medical Center
07740 Long Branch
United StatesRekrutierend» Google-Maps
Newark Beth Israel Medical Center
07112 Newark
United StatesRekrutierend» Google-Maps
Robert Wood Johnson University Hospital Somerset
08876 Somerville
United StatesRekrutierend» Google-Maps
Community Medical Center
08755 Toms River
United StatesRekrutierend» Google-Maps
Thomas Jefferson University
19107 Philadelphia
United StatesAbgeschlossen» Google-Maps
Thomas Jefferson University
19114 Philadelphia
United StatesAbgeschlossen» Google-Maps
Thomas Jefferson University
19090 Willow Grove
United StatesAbgeschlossen» Google-Maps
Charleston Oncology
29414 Charleston
United StatesAbgeschlossen» Google-Maps
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Erika P Hamilton
Phone: 615-329-7274
E-Mail: Erika.hamilton@scri.com
» Ansprechpartner anzeigen
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
98109 Seattle
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Natasha Hunter
Phone: 206-288-7222
E-Mail: nhunter@uw.edu
» Ansprechpartner anzeigen
Cancer Research South Australia
5000 Adelaide
AustraliaRekrutierend» Google-Maps
Flinders Medical Centre
5042 Bedford Park
AustraliaRekrutierend» Google-Maps
Peninsula and South East Oncology
3199 Frankston
AustraliaAbgeschlossen» Google-Maps
Macquarie University Hospital
2109 Macquarie University
AustraliaRekrutierend» Google-Maps
St John of God Subiaco Hospital
6008 Subiaco
AustraliaRekrutierend» Google-Maps
Medizinische Universitat Innsbruck
A-6020 Innsbruck
AustriaRekrutierend» Google-Maps
Ordensklinikum Linz GmbH Barmherzige Schwestern
A-4010 Linz
AustriaRekrutierend» Google-Maps
Ordination Priv.-Doz. Dr. M. Hubalek
6130 Schwaz
AustriaRekrutierend» Google-Maps
AKH - Medizinische Universitat Wien
1090 Vienna
AustriaRekrutierend» Google-Maps
Universitair Ziekenhuis Brussel
1090 Bruxelles-Capitale
BelgiumRekrutierend» Google-Maps
Hospital de Cancer de Barretos - Fundacao Pio XII
14784-400 Barretos
BrazilRekrutierend» Google-Maps
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda.
01317-001 Bela Vista
BrazilRekrutierend» Google-Maps
INCAN - Instituto do Cancer - Hospital Pompeia
95010-005 Caxias do Sul
BrazilAbgeschlossen» Google-Maps
Centro Regional Integrado de Oncologia
60336-045 Fortaleza
BrazilRekrutierend» Google-Maps
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
74605-070 Goiania
BrazilRekrutierend» Google-Maps
Fundacao Doutor Amaral Carvalho
17210-120 Jaú
BrazilRekrutierend» Google-Maps
Hospital do Cancer de Londrina
86015-520 Londrina
BrazilRekrutierend» Google-Maps
Liga Norte-Rio-Grandense Contra o Cancer
59151-600 Natal
BrazilRekrutierend» Google-Maps
Irmandade da Santa Casa de Misericordia de Porto Alegre
90020-090 Porto Alegre
BrazilRekrutierend» Google-Maps
Hospital de Clinicas de Porto Alegre
90035-903 Porto Alegre
BrazilRekrutierend» Google-Maps
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
90110-270 Porto Alegre
BrazilRekrutierend» Google-Maps
Hospital Nossa Senhora da Conceicao
91350-200 Porto Alegre
BrazilRekrutierend» Google-Maps
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
09060-870 Santo Andre
BrazilRekrutierend» Google-Maps
Praxis Pesquisa Medica
09090-790 Santo Andre
BrazilAbgeschlossen» Google-Maps
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
15090-000 Sao Jose Rio Preto
BrazilRekrutierend» Google-Maps
Fundacao Antonio Prudente (AC Camargo Cancer Center)
01509-010 Sao Paulo
BrazilRekrutierend» Google-Maps
ICESP - Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
01246-000 São Paulo
BrazilRekrutierend» Google-Maps
University of Alberta / Cross Cancer Institute
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-Maps
Ottawa Hospital Cancer Centre
K1H 8L6 Ottawa
CanadaRekrutierend» Google-Maps
Sunnybrook Health Sciences Centre
M4N 3M5 Toronto
CanadaRekrutierend» Google-Maps
Mount Sinai Hospital - Toronto
M5G1X2 Toronto
CanadaRekrutierend» Google-Maps
CIUSSS du Saguenay Lac Saint Jean
G7H 5H6 Chicoutimi
CanadaRekrutierend» Google-Maps
Centre Hospitalier de l'Universite de Montreal
H2X 3E4 Montreal
CanadaRekrutierend» Google-Maps
Centro de Investigacion Clinica Bradford Hill
13127 Santiago
ChileRekrutierend» Google-Maps
Pontificia Universidad Catolica De Chile Santiago
7770177 Santiago
ChileRekrutierend» Google-Maps
Clinica Universidad Catolica del Maule
3460000 Talca
ChileRekrutierend» Google-Maps
Sociedad de Investigaciones Medicas Limitada
4810469 Temuco
ChileRekrutierend» Google-Maps
Affiliated Hospital of Hebei University
071000 Baoding
ChinaRekrutierend» Google-Maps
The First Bethune Hospital of Jilin University
130021 Changchun
ChinaRekrutierend» Google-Maps
The Second Xiangya Hospital of Central South University
410011 Changsha
ChinaRekrutierend» Google-Maps
Affiliated Hospital of Chengde Medical University
067000 Chengde
ChinaAbgeschlossen» Google-Maps
The First People's Hospital of Foshan
528000 Foshan
ChinaAbgeschlossen» Google-Maps
Fujian Provincial Cancer Hospital
350015 Fuzhou
ChinaAbgeschlossen» Google-Maps
900TH Hospital of Joint Logistics Support Force
350025 Fuzhou
ChinaAbgeschlossen» Google-Maps
Guangdong Provincial People's Hospital
510081 Guangzhou
ChinaRekrutierend» Google-Maps
The first Affiliated Hospital of Hainan Medical University
570102 Haikou
ChinaRekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Hangzhou City
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of Zhejiang University School of Medicine
310009 Hangzhou
ChinaRekrutierend» Google-Maps
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
310016 Hangzhou
ChinaRekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaAbgeschlossen» Google-Maps
The Second Hospital of Anhui Medical University
230601 Hefei
ChinaRekrutierend» Google-Maps
The Affiliated Hospital of Inner Mongolia Medical University
010050 Hohhot
ChinaAbgeschlossen» Google-Maps
Meizhou People's Hospital - Guangdong Province
514031 Meizhou
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of Nanchang University
330006 Nanchang
ChinaRekrutierend» Google-Maps
Nanjing Medical University (NMU) - Jiangsu Province Hospital
210029 Nanjing
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Guangxi Medical University
530021 Nanning
ChinaRekrutierend» Google-Maps
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
200025 Shanghai
ChinaRekrutierend» Google-Maps
Fudan University Shanghai Cancer Center
200030 Shanghai
ChinaRekrutierend» Google-Maps
The First Hospital of China Medical University
110001 Shenyang
ChinaRekrutierend» Google-Maps
Liaoning Cancer Hospital and Institute
110042 Shenyang
ChinaRekrutierend» Google-Maps
Tianjin Medical University - Cancer Institute & Hospital
453000 Tianjin
ChinaRekrutierend» Google-Maps
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
430030 Wuhan City
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Xi'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-Maps
Shaanxi Provincial People's Hospital
710068 Xi'an
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Xinxiang Medical University
453700 Xinxiang
ChinaAbgeschlossen» Google-Maps
The Affiliated Hospital of Xuzhou Medical College
221006 Xuzhou
ChinaAbgeschlossen» Google-Maps
Henan Provincial People's Hospital
450003 Zhengzhou
ChinaAbgeschlossen» Google-Maps
Nanchang Third Hospital
330009 Nanchang City
ChinaAbgeschlossen» Google-Maps
Guangxi Medical University Affiliated Tumor Hospital
530021 Nanning
ChinaRekrutierend» Google-Maps
Masaryk Memorial Cancer Institute
62800 Brno
CzechiaRekrutierend» Google-Maps
Vseobecna fakultni nemocnice v Praze
128 08 Praha 2
CzechiaRekrutierend» Google-Maps
Thomayer University Hospital (Fakultní Thomayerova nemocnice)
140 59 Praha 4-Krc
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice v Motole
150 06 Praha 5
CzechiaRekrutierend» Google-Maps
Nemocnice Horovice (NH Hospital) a.s.
155 00 Praha
CzechiaRekrutierend» Google-Maps
Helsinki University Hospital
00290 Helsinki
FinlandRekrutierend» Google-Maps
Tampere University Hospital
33520 Tampere, Pirkanmaa
FinlandRekrutierend» Google-Maps
Sainte Catherine Institut du Cancer Avignon Provence
84000 Avignon
FranceRekrutierend» Google-Maps
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
25000 Besancon Cedex
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire Hopital Avicenne
93000 Bobigny
FranceRekrutierend» Google-Maps
Centre de Lutte contre le Cancer - Francois Baclesse
14076 Caen Cedex 5
FranceRekrutierend» Google-Maps
CARIO - Centre Armoricain De Radiothérapie, D'imagerie Médicale Et D'oncologie
22190 Cotes d'Armor
FranceRekrutierend» Google-Maps
Center Georges Francois Leclerc
21000 Dijon
FranceRekrutierend» Google-Maps
Centre de Lutte contre le Cancer (CLCC) - Centre Oscar Lambret
59000 Lille
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
87042 Limoges Cedex
FranceRekrutierend» Google-Maps
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
69008 Lyon cedex 08
FranceRekrutierend» Google-Maps
Centre de Cancerologie du Grand Montpellier
34070 Montpellier
FranceRekrutierend» Google-Maps
Institut Regional du Cancer de Montpellier
34298 Montpellier
FranceRekrutierend» Google-Maps
Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne
06189 Nice Cedex 2
FranceRekrutierend» Google-Maps
Hopitaux Civils de Lyon
69310 Pierre Benite
FranceRekrutierend» Google-Maps
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
76038 Rouen
FranceRekrutierend» Google-Maps
Institut de Cancerologie de lOuest - Site Rene Gauducheau
44800 Saint Herblain cedex
FranceRekrutierend» Google-Maps
Institut de cancerologie Strasbourg Europe
67033 Strasbourg
FranceRekrutierend» Google-Maps
Alexandra General Hospital of Athens
11528 Athens
GreeceRekrutierend» Google-Maps
University General Hospital of Heraklion (PAGNI)
711 10 Heraklion
GreeceRekrutierend» Google-Maps
University Hospital of Larissa
41110 Larissa
GreeceRekrutierend» Google-Maps
General Hospital of Thessaloniki Papageorgiou
TK 56403 Nea Efkarpia
GreeceRekrutierend» Google-Maps
Metropolitan General Hospital
185 47 Neo Faliro
GreeceRekrutierend» Google-Maps
Metaxa Anticancer Hospital of Piraeus
18537 Pireaus
GreeceRekrutierend» Google-Maps
Euromedica General Clinic
54645 Thessaloniki
GreeceRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria di Ferrara
44124 Cona (FE)
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria San Martino
16132 Genova
ItalyRekrutierend» Google-Maps
Azienda Usl Toscana Nord Ovest
56124 Livorno
ItalyRekrutierend» Google-Maps
Humanitas Istituto Clinico Catanese
95045 Misterbianco (CT)
ItalyRekrutierend» Google-Maps
Fondazione IRCCS San Gerardo dei Tintori
20900 Monza
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria (AOU) Federico II
80131 Napoli
ItalyRekrutierend» Google-Maps
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
80131 Napoli
ItalyRekrutierend» Google-Maps
Ospedale Sacro Cuore Don Calabria
37024 Negrar Di Valpolicella
ItalyAbgeschlossen» Google-Maps
Istituto Oncologico Veneto - IRCCS
35128 Padova
ItalyRekrutierend» Google-Maps
XX.Servizio Sanitario Regionale Emilia-Romagna Azienda Ospedaliero Universitaria di Parma
43126 Parma
ItalyRekrutierend» Google-Maps
Azienda USL 4 Prato - Ospedale Misericordia e Dolce di Prato
59100 Prato
ItalyRekrutierend» Google-Maps
Istituto Clinico Humanitas-Humanitas Cancer Center
20089 Rozzano (Milano)
ItalyRekrutierend» Google-Maps
A.O.U. - Ospedali Riuniti di Ancona
60126 Torrette (AN)
ItalyRekrutierend» Google-Maps
Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di Trento - Presidio Ospedaliero S. Chiara
38122 Trento
ItalyRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-ku
JapanRekrutierend» Google-Maps
St. Luke's International Hospital
104-8560 Chuo-ku
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka-shi
JapanRekrutierend» Google-Maps
Fukushima Medical University Hospital
960-1295 Fukushima-shi
JapanRekrutierend» Google-Maps
University of Tsukuba Hospital
305-8576 Ibaraki
JapanRekrutierend» Google-Maps
Tesshokai Kameda General Hospital
296-8602 Kamogawa-shi
JapanRekrutierend» Google-Maps
Ishikawa Prefectural Central Hospital
920-8530 Kanazawa-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps
NHO Shikoku Cancer Center
791-0280 Matsuyama
JapanRekrutierend» Google-Maps
Kindai University Hospital
589-8511 Osakasayama-Shi
JapanRekrutierend» Google-Maps
National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo-shi
JapanRekrutierend» Google-Maps
Showa University Hospital
142-8666 Shinagawa-ku
JapanRekrutierend» Google-Maps
Dong-A University Hospital
49201 Busan
Korea, Republic ofRekrutierend» Google-Maps
Chungbuk National University Hospital
28644 Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Korea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul Saint Mary's Hospital
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ewha Womans University Mokdong Hospital
07985 Seoul
Korea, Republic ofRekrutierend» Google-Maps
St. Vincent's Hospital, The Catholic University of Korea
16247 Suwon-si
Korea, Republic ofRekrutierend» Google-Maps
Ajou University Hospital
16499 Suwon-si
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
26426 Wonju-si
Korea, Republic ofRekrutierend» Google-Maps
Gangnam Severance Hospital
06273 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Netherlands Cancer Institute
1066 WX Amsterdam
NetherlandsRekrutierend» Google-Maps
Albert Schweitzer Hospital
3318AT Doedrecht
NetherlandsRekrutierend» Google-Maps
Medisch Centrum Leeuwarden (MCL)
8934 AD Leeuwarden
NetherlandsRekrutierend» Google-Maps
St. Antonius Hospital
3435 CM Nieuwegein
NetherlandsRekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne
80-214 Gdansk
PolandRekrutierend» Google-Maps
Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)
44-102 Gliwice
PolandRekrutierend» Google-Maps
Przychodnia Lekarska KOMED Roman Karaszewski
62-500 Konin
PolandAbgeschlossen» Google-Maps
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi
93-513 Lodz
PolandRekrutierend» Google-Maps
SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
45-061 Opole
PolandRekrutierend» Google-Maps
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
02-761 Warszawa
PolandRekrutierend» Google-Maps
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
3000-075 Coimbra
PortugalRekrutierend» Google-Maps
Champalimaud Clinical Center
1400-038 Lisbon
PortugalRekrutierend» Google-Maps
Centro Hospitalar De Vila Nova De Gaia Espinho
4434-502 Vila Nova de Gaia
PortugalRekrutierend» Google-Maps
Hospital General Universitario Alicante
03010 Alicante
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital de la Santa Creu i Sant Pau
08041 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario de Basurto
48013 Bilbao
SpainRekrutierend» Google-Maps
Complejo Hospitalario De Caceres - Hospital General San Pedro De Alcantara
10003 Caceres
SpainRekrutierend» Google-Maps
Institut Catala d'Oncologia Girona - ICO Girona
17007 Girona
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen de las Nieves
18014 Granada
SpainRekrutierend» Google-Maps
Hospital Universitari Arnau de Vilanova
25198 Lleida
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Maranon
28007 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen de la Victoria
29010 Malaga
SpainRekrutierend» Google-Maps
Hospital Clínico Universitario Virgen de la Arrixaca
30120 El Palmar Murcia
SpainRekrutierend» Google-Maps
Hospital Universitario Son Espases
07120 Palma de Mallorca
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Hospital Universitario de Canarias
38320 San Cristóbal de la Laguna
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps
Valencian Institute of Oncology Foundation
46009 Valencia
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps
Kantonsspital Winterthur (KSW)
8401 Winterthur
SwitzerlandRekrutierend» Google-Maps
Kaohsiung Medical University Hospital
807 Kaohsiung
TaiwanRekrutierend» Google-Maps
Taipei Medical University Hospital
23561 New Taipei City
TaiwanRekrutierend» Google-Maps
China Medical University Hospital
40447 Taichung
TaiwanRekrutierend» Google-Maps
National Cheng-Kung University Hospital
704 Tainan
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital
11217 Taipei
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Sun Yat-sen University Cancer Center
112 Taipei
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Central Hospital of the Ministry of National Defense
11490 Taipei
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Chang Gung Memorial Hospital - Linkou
333 Taoyuan
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National Taiwan University Hospital
10002 Taipei
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The University of Edinburgh
EH4 2XU Edinburgh
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University College London Hospitals NHS Foundation Trust
NW1 2PG London
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Royal Free London NHS Foundation Trust
NW3 2QG London
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The Royal Marsden NHS Foundation Trust (RM)
SW3 6JJ London
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Christie Hospital NHS Foundation Trust
M20 4BX Manchester
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The Royal Marsden NHS Foundation Trust (RM)
SM2 5PT Sutton
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Alle anzeigen

Studien-Informationen

Detailed Description:

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Time Frame - Up to approximately 3 years):
The time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause



Secondary outcome:

1. Overall survival (OS) (Time Frame - Up to approximately 5 years):
The time from randomization to death from any cause.

2. PFS by blinded independent central review (BICR) per RECIST v1.1 (Time Frame - Up to approximately 3 years):
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

3. Time to deterioration of health-related quality of life (HRQoL) (Time Frame - Up to approximately 3 years):
Will be measured based on patient reported outcomes (PROs) according to the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ C30).

4. Central nervous system (CNS) PFS (Time Frame - Up to approximately 3 years):
The time from randomization to investigator assessed disease progression in brain (RECIST v1.1), or death from any cause

5. Incidence of adverse events (AEs) (Time Frame - Through 30 days after last study treatment, approximately 18 months):
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

6. Incidence of laboratory abnormalities (Time Frame - Through 30 days after last study treatment, approximately 18 months):
To be summarized using descriptive statistics.

7. Incidence of tucatinib dose alterations (Time Frame - Through 30 days after last study treatment, approximately 18 months):
To be summarized using descriptive statistics.

8. Incidence of trastuzumab dose alterations (Time Frame - Through 30 days after last study treatment, approximately 18 months):
To be summarized using descriptive statistics.

9. Incidence of pertuzumab dose alterations (Time Frame - Through 30 days after last study treatment, approximately 18 months):
To be summarized using descriptive statistics.

10. Maximum concentration (Cmax) (Time Frame - Through 30 days after last study treatment, approximately 18 months):
To be summarized using descriptive statistics.

11. Trough concentration (Ctrough) (Time Frame - Through 30 days after last study treatment, approximately 18 months):
To be summarized using descriptive statistics.

Studien-Arme

  • Experimental: Tucatinib + trastuzumab + pertuzumab
    Tucatinib + trastuzumab + pertuzumab
  • Active Comparator: Placebo + trastuzumab + pertuzumab
    Placebo + trastuzumab + pertuzumab

Geprüfte Regime

  • Tucatinib (TUKYSA, ONT-380, ARRY-380):
    300mg given by mouth (orally) twice daily
  • Trastuzumab (Herceptin, Herceptin Hylecta):
    6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
  • Pertuzumab (Perjeta):
    420mg given by IV every 21 days
  • Combination product: Trastuzumab + Pertuzumab (Phesgo):
    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.
  • Placebo:
    Given orally twice daily

Quelle: ClinicalTrials.gov


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"A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer"

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