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JOURNAL ONKOLOGIE – STUDIE

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

Rekrutierend

NCT-Nummer:
NCT03975647

Studienbeginn:
Oktober 2019

Letztes Update:
09.04.2024

Wirkstoff:
Tucatinib, Placebo, T-DM1

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Seagen Inc.

Collaborator:
-

Studienleiter

Kit Wong, MD
Study Director
Seagen Inc.

Kontakt

Studienlocations
(3 von 274)

Helios Klinikum Berlin-Buch
13125 Berlin
(Berlin)
GermanyAbgeschlossen» Google-Maps
Stadtisches Klinikum Dessau
06847 Dessau-Rosslau
(Sachsen-Anhalt)
GermanyAbgeschlossen» Google-Maps
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
45136 Essen
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Universitaetsklinikum Hamburg-Eppendorf (UKE)
20246 Hamburg
(Hamburg)
GermanyAbgeschlossen» Google-Maps
Universitatsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Universitatsklinikum Schleswig-Holstein
24105 Kiel
(Schleswig-Holstein)
GermanyAktiv, nicht rekrutierend» Google-Maps
InVO- Institut fUr Versorgungsforschung in der onkologie GbR
56068 Koblenz
(Rheinland-Pfalz)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
55101 Mainz
(Rheinland-Pfalz)
GermanyAktiv, nicht rekrutierend» Google-Maps
Klinikum Rechts der Isar der Technischen Universitaet Muenchen
81675 Muenchen
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Klinikum der Universitat Munchen
80337 Munchen
(Bayern)
GermanyAbgeschlossen» Google-Maps
Sana Klinikum Offenbach GmbH
63069 Offenbach am Main
(Hessen)
GermanyAbgeschlossen» Google-Maps
University of Rostock
18059 Rostock
(Mecklenburg-Vorpommern)
GermanyAbgeschlossen» Google-Maps
University of South Alabama - Mitchell Cancer Institute
36604 Mobile
United StatesAktiv, nicht rekrutierend» Google-Maps
Ironwood Cancer & Research Centers - Chandler
85224 Chandler
United StatesAbgeschlossen» Google-Maps
Banner MD Anderson Cancer Center
85234 Gilbert
United StatesAktiv, nicht rekrutierend» Google-Maps
Cancer Treatment Centers of America / Western Regional Medical Center
85338 Goodyear
United StatesAktiv, nicht rekrutierend» Google-Maps
Arizona Oncology Associates, PC - HAL
85016 Phoenix
United StatesAbgeschlossen» Google-Maps
Arizona Oncology Associates, PC - HOPE
85710 Tucson
United StatesAbgeschlossen» Google-Maps
St. Bernards Medical Center
72401 Jonesboro
United StatesAbgeschlossen» Google-Maps
City of Hope National Medical Center
91010-3000 Duarte
United StatesAbgeschlossen» Google-Maps
California Cancer Associates for Research and Excellence Inc (cCARE)
92024 Encinitas
United StatesAbgeschlossen» Google-Maps
St. Joseph Heritage Healthcare TRIO
92835 Fullerton
United StatesAbgeschlossen» Google-Maps
Chao Family Comprehensive Cancer Center University of California Irvine
92868 Orange
United StatesAktiv, nicht rekrutierend» Google-Maps
University of California Irvine - Newport
92868 Orange
United StatesAktiv, nicht rekrutierend» Google-Maps
University of California Davis
95817 Sacramento
United StatesAktiv, nicht rekrutierend» Google-Maps
San Francisco General Hospital
94110 San Francisco
United StatesAbgeschlossen» Google-Maps
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
94134 San Francisco
United StatesAbgeschlossen» Google-Maps
UCLA Department of Medicine - Hematology & Oncology
90404 Santa Monica
United StatesAktiv, nicht rekrutierend» Google-Maps
Torrance Memorial Physician Network - TRIO
90505 Torrance
United StatesAktiv, nicht rekrutierend» Google-Maps
Kaiser Permanente Medical Center Northern California
94589 Vallejo
United StatesAktiv, nicht rekrutierend» Google-Maps
Rocky Mountain Cancer Centers - Aurora
80012 Aurora
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Colorado Hospital / University of Colorado
80045-0510 Aurora
United StatesAktiv, nicht rekrutierend» Google-Maps
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
80021 Broomfield
United StatesAbgeschlossen» Google-Maps
University of Colorado Health Memorial Hospital
80909 Colorado Springs
United StatesAbgeschlossen» Google-Maps
Cancer Centers of Colorado - Denver
80218 Denver
United StatesAbgeschlossen» Google-Maps
Poudre Valley Health System (PVHS)
80524 Fort Collins
United StatesAktiv, nicht rekrutierend» Google-Maps
Helen F. Graham Cancer Center / Christiana Care Health Systems
19713 Newark
United StatesAbgeschlossen» Google-Maps
Lombardi Cancer Center / Georgetown University Medical Center
20007 Washington
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists - South Region
33901 Fort Myers
United StatesAktiv, nicht rekrutierend» Google-Maps
Baptist MD Anderson Cancer Center
32207 Jacksonville
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Miami
33136 Miami
United StatesAktiv, nicht rekrutierend» Google-Maps
Miami Cancer Institute at Baptist Health, Inc.
33176 Miami
United StatesAktiv, nicht rekrutierend» Google-Maps
AdventHealth Cancer Institute
32804 Orlando
United StatesAktiv, nicht rekrutierend» Google-Maps
Orlando Health, Inc. TRIO
32806 Orlando
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists - North Region
33705 Saint Petersburg
United StatesAktiv, nicht rekrutierend» Google-Maps
H. Lee Moffitt Cancer Center and Research Institute
33612 Tampa
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists - East West Palm Beach, FL (SCRI)
33401 West Palm Beach
United StatesAbgeschlossen» Google-Maps
Winship Cancer Institute / Emory University School of Medicine
30322 Atlanta
United StatesAbgeschlossen» Google-Maps
Augusta University
30912 Augusta
United StatesAktiv, nicht rekrutierend» Google-Maps
Northside Hospital
30115 Canton
United StatesAktiv, nicht rekrutierend» Google-Maps
Kaiser Permanente Moanalua Medical Center
96819 Honolulu
United StatesAbgeschlossen» Google-Maps
Kapi'olani Medical Center for Women and Children
96826 Honolulu
United StatesAktiv, nicht rekrutierend» Google-Maps
Illinois Cancer Specialists - Arlington Heights
60005 Arlington Heights
United StatesAbgeschlossen» Google-Maps
Rush University Medical Center
60612 Chicago
United StatesAbgeschlossen» Google-Maps
University of Chicago Medical Center
60637-1470 Chicago
United StatesAbgeschlossen» Google-Maps
Illinois Cancer Care
61615 Peoria
United StatesAktiv, nicht rekrutierend» Google-Maps
Ft Wayne Medical Oncology and Hematology, Inc TRIO
46804 Fort Wayne
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Kansas Medical Center
66160 Kansas City
United StatesAktiv, nicht rekrutierend» Google-Maps
CHI Saint Joseph Medical Group Cancer Care Center
40509 Lexington
United StatesAbgeschlossen» Google-Maps
Ochsner Medical Center
70121 New Orleans
United StatesAbgeschlossen» Google-Maps
University of Maryland
21201 Baltimore
United StatesAbgeschlossen» Google-Maps
Mercy Medical Center -Weinberg Center
21202 Baltimore
United StatesAbgeschlossen» Google-Maps
American Oncology Networks LLC
20817 Bethesda
United StatesAbgeschlossen» Google-Maps
Maryland Oncology Hematology, P.A.
20850 Rockville
United StatesAktiv, nicht rekrutierend» Google-Maps
Beth Israel Deaconess Medical Center
02215 Boston
United StatesAbgeschlossen» Google-Maps
Dana Farber Cancer Institute
02215 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Michigan Comprehensive Cancer Center
48109 Ann Arbor
United StatesAktiv, nicht rekrutierend» Google-Maps
Henry Ford Health System
48202 Detroit
United StatesAktiv, nicht rekrutierend» Google-Maps
Minnesota Oncology Hematology P.A.
55404 Minneapolis
United StatesAktiv, nicht rekrutierend» Google-Maps
North Mississippi Medical Center Hematology Oncology - Tupelo
38801 Tupelo
United StatesAbgeschlossen» Google-Maps
Saint Luke's Cancer Institute LLC
64113 Kansas City
United StatesAktiv, nicht rekrutierend» Google-Maps
HCA Midwest Health Kansas City
64132 Kansas City
United StatesAktiv, nicht rekrutierend» Google-Maps
Washington University in St Louis
63110 Saint Louis
United StatesAktiv, nicht rekrutierend» Google-Maps
St. Vincent Frontier Cancer Center
59102 Billings
United StatesAktiv, nicht rekrutierend» Google-Maps
Nebraska Cancer Specialists
68130 Omaha
United StatesAktiv, nicht rekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada
89169 Las Vegas
United StatesAktiv, nicht rekrutierend» Google-Maps
Summit Medical Group
07932 Florham Park
United StatesAbgeschlossen» Google-Maps
Saint Barnabas Medical Center Cancer Center
07039 Livingston
United StatesAktiv, nicht rekrutierend» Google-Maps
Rutgers Cancer Institute of New Jersey
08903-2681 New Brunswick
United StatesAktiv, nicht rekrutierend» Google-Maps
New York Oncology Hematology, P.C.
12206 Albany
United StatesAktiv, nicht rekrutierend» Google-Maps
Stony Brook University Cancer Center
11794-7263 Stony Brook
United StatesAbgeschlossen» Google-Maps
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
27599 Chapel Hill
United StatesAbgeschlossen» Google-Maps
Levine Cancer Institute
28204 Charlotte
United StatesAbgeschlossen» Google-Maps
Duke University Medical Center
27710 Durham
United StatesAktiv, nicht rekrutierend» Google-Maps
Providence Portland Medical Center
97213 Portland
United StatesAktiv, nicht rekrutierend» Google-Maps
Oregon Health and Science University
97239-3098 Portland
United StatesAktiv, nicht rekrutierend» Google-Maps
Northwest Cancer Specialists, P.C.
97223 Tigard
United StatesAbgeschlossen» Google-Maps
University of Pennsylvania / Perelman Center for Advanced Medicine
19104 Philadelphia
United StatesAktiv, nicht rekrutierend» Google-Maps
Cancer Treatment Centers of America / Eastern Regional Medical Center
19124 Philadelphia
United StatesAbgeschlossen» Google-Maps
Brig Center for Cancer Care and Survivorship
37909 Knoxville
United StatesAbgeschlossen» Google-Maps
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
37203 Nashville
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology - Amarillo
79124 Amarillo
United StatesAbgeschlossen» Google-Maps
Texas Oncology - Austin Central
78731 Austin
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology - DFW
76022 Bedford
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology - Methodist Dallas Cancer Center
75203 Dallas
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology - Medical City Dallas
75230 Dallas
United StatesAbgeschlossen» Google-Maps
Texas Oncology - Baylor Sammons Cancer Center
75246 Dallas
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Texas Southwestern Medical Center
75390 Dallas
United StatesAbgeschlossen» Google-Maps
The Center for Cancer and Blood Disorders: Fortworth
76104 Fort Worth
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology - Houston Memorial City
77024 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
MD Anderson Cancer Center / University of Texas
77030-4095 Houston
United StatesAbgeschlossen» Google-Maps
Baylor Clinic
77030 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
Oncology Consultants, PA
77030 Houston
United StatesAbgeschlossen» Google-Maps
Texas Oncology - San Antonio Medical Center
78240 San Antonio
United StatesAktiv, nicht rekrutierend» Google-Maps
Huntsman Cancer Institute/University of Utah
84112 Salt Lake City
United StatesAbgeschlossen» Google-Maps
Virginia Cancer Specialists, PC
22031 Fairfax
United StatesAktiv, nicht rekrutierend» Google-Maps
Saint Francis Hospital / Bon Secours - Virginia
23114 Midlothian
United StatesAbgeschlossen» Google-Maps
Peninsula Cancer Institute
23601 Newport News
United StatesAbgeschlossen» Google-Maps
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
24153 Salem
United StatesAktiv, nicht rekrutierend» Google-Maps
Swedish Cancer Institute - Edmonds
98026 Edmonds
United StatesAktiv, nicht rekrutierend» Google-Maps
Swedish Cancer Institute - Issaquah
98029 Issaquah
United StatesAktiv, nicht rekrutierend» Google-Maps
Swedish Cancer Institute
98104 Seattle
United StatesAktiv, nicht rekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3000 Melbourne
AustraliaAktiv, nicht rekrutierend» Google-Maps
Austin Health
3084 Melbourne
AustraliaAktiv, nicht rekrutierend» Google-Maps
Breast Cancer Research Centre
6009 Nedlands
AustraliaAktiv, nicht rekrutierend» Google-Maps
Westmead Hospital
2145 Westmead
AustraliaAktiv, nicht rekrutierend» Google-Maps
Medizinische Universitat Innsbruck
6020 Innsbruck
AustriaAbgeschlossen» Google-Maps
LKH Salzburg, Universitatsklinikum der PMU
5020 Salzburg
AustriaAbgeschlossen» Google-Maps
Medizinische Universitat Wien
1090 Vienna
AustriaAbgeschlossen» Google-Maps
Institut Jules Bordet
B-1070 Anderlecht
BelgiumAktiv, nicht rekrutierend» Google-Maps
Cliniques Universitaires Saint Luc
1200 Brussels
BelgiumAbgeschlossen» Google-Maps
Grand Hôpital de Charleroi - Saint-Joseph
6000 Charleroi
BelgiumAbgeschlossen» Google-Maps
Universitair Ziekenhuis Antwerpen
2650 Edegem
BelgiumAktiv, nicht rekrutierend» Google-Maps
Academisch Ziekenhuis Groeninge
8500 Kortrijk
BelgiumAktiv, nicht rekrutierend» Google-Maps
Universitair Ziekenhuis Leuven
3000 Lueven
BelgiumAktiv, nicht rekrutierend» Google-Maps
CHU UCL Namur-Site de Saint Elisabeth
5000 Namur
BelgiumAktiv, nicht rekrutierend» Google-Maps
University of Alberta / Cross Cancer Institute
T6G 1Z2 Edmonton
CanadaAktiv, nicht rekrutierend» Google-Maps
Queen Elizabeth II Health Sciences Centre
B3H 2Y9 Halifax
CanadaAbgeschlossen» Google-Maps
Cancer Centre of Southeastern Ontario At Kingston General Hospital
K7L 5P9 Kingston
CanadaAbgeschlossen» Google-Maps
London Health Sciences Centre - Victoria Hospital
N6A 5W9 London
CanadaAktiv, nicht rekrutierend» Google-Maps
University of Ottawa / Ottawa General Hospital
K1H 8L6 Ottawa
CanadaAktiv, nicht rekrutierend» Google-Maps
University Health Network, Princess Margaret Hospital
M5G 2M9 Toronto
CanadaAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier de l'Universite de Montreal
H2X 3E4 Montreal
CanadaAktiv, nicht rekrutierend» Google-Maps
Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval
G1S 4L8 Quebec
CanadaAktiv, nicht rekrutierend» Google-Maps
Cancer Hospital Chinese Academy of Medical Sciences
100021 Beijing City
ChinaRekrutierend» Google-Maps
Peking University People's Hospital
100044 Beijing
ChinaRekrutierend» Google-Maps
Jilin Province Cancer Hospital
130012 Changghun
ChinaRekrutierend» Google-Maps
Sun Yat-sen University Cancer Center
510060 Guangzhou City
ChinaRekrutierend» Google-Maps
Guangdong Provincial People's Hospital
510080 Guangzhou
ChinaRekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Hangzhou City
ChinaRekrutierend» Google-Maps
First Affiliated Hospital of Zhejiang University
Hangzhou City
ChinaAbgeschlossen» Google-Maps
The Second Affiliated Hospital of Zhejiang University School of Medicine
0571 Hangzhou
ChinaRekrutierend» Google-Maps
Gulou Hospital Affiliated to Nanjing University Medical College
210008 Nanjing
ChinaRekrutierend» Google-Maps
Shengjing Hospital of China Medical University
110022 Shenyang City
ChinaRekrutierend» Google-Maps
Tianjin Medical University - Cancer Institute & Hospital
453000 Tianjin
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Xi'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-Maps
Xi'An International Medical Center Hospital
710100 Xi'An
ChinaRekrutierend» Google-Maps
The Affiliated Hospital of Xuzhou Medical College
22100 Xuzhou
ChinaRekrutierend» Google-Maps
The Affiliated Hospital of Guangdong Medical University
524000 Zhan Jiang City
ChinaRekrutierend» Google-Maps
Zigong First People's Hospital
643000 Zigong City
ChinaRekrutierend» Google-Maps
Center of Women and Children Hospital of Guangdong Province
511400 Guangzhou
ChinaRekrutierend» Google-Maps
Nanchang Third Hospital
330009 Nanchang City
ChinaRekrutierend» Google-Maps
Guangxi Medical University Affiliated Tumor Hospital
530021 Nanning
ChinaRekrutierend» Google-Maps
Aalborg Universitetshospital
9100 Aalborg
DenmarkAbgeschlossen» Google-Maps
Odense University Hospital
5000 Odense C
DenmarkAktiv, nicht rekrutierend» Google-Maps
Sygehus Lillebaelt - Vejle Sygehus
7100 Vejle
DenmarkAktiv, nicht rekrutierend» Google-Maps
University Hospital of Besancon
25030 Besancon cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Hospital Center Regional University Morvan De Brest
29200 Brest
FranceAbgeschlossen» Google-Maps
Centre de Lutte contre le Cancer - François Baclesse
14076 Caen Cedex 5
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Europeen Georges Pompidou
75908 Cedex 15
FranceAbgeschlossen» Google-Maps
Center Georges Francois Leclerc
21000 Dijon
FranceAktiv, nicht rekrutierend» Google-Maps
Clinique Victor Hugo Le Mans
72000 Le Mans
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
69008 Lyon cedex 08
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Paoli Calmettes
13273 Marseille
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Saint-Louis / Service d'Hematologie
75475 Paris Cedex 10
FranceAbgeschlossen» Google-Maps
Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris
75298 CEDEX 05 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
76038 Rouen
FranceAbgeschlossen» Google-Maps
Hopitaux Universitaires de Strasbourg
67200 Strasbourg
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Claudius Regaud IUCT-O
31059 Toulouse Cedex 9
FranceAktiv, nicht rekrutierend» Google-Maps
CHU Tours - Hopital Bretonneau
37044 TOURS Cedex 09
FranceAktiv, nicht rekrutierend» Google-Maps
Shaare Zedek Medical Center
9103102 Jerusalem
IsraelAbgeschlossen» Google-Maps
Rabin Medical Center
49414 Petach Tikva
IsraelAktiv, nicht rekrutierend» Google-Maps
Kaplan Medical Center
76100 Rehovot
IsraelAktiv, nicht rekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
40138 Bologna
ItalyAbgeschlossen» Google-Maps
Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo FPO - IRCCS
10060 Candiolo
ItalyAbgeschlossen» Google-Maps
Istituto Europeo di Oncologia
20141 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
Seconda Università degli Studi di Napoli, AOU
80131 Napoli
ItalyAbgeschlossen» Google-Maps
Nuovo Ospedale di Prato - Santo Stefano
59100 Prato
ItalyAbgeschlossen» Google-Maps
Policlinico Universitario Agostino Gemelli
00168 Roma
ItalyAbgeschlossen» Google-Maps
Azienda Ospedaliera S. Maria di Terni
05100 Terni
ItalyAbgeschlossen» Google-Maps
A.O.U. - Ospedali Riuniti di Ancona
60126 Torrette
ItalyAbgeschlossen» Google-Maps
Chiba Cancer Center
260-8717 Chiba
JapanAktiv, nicht rekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-ku
JapanAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Hiroshima City Hiroshima Citizens Hospital
730-8518 Hiroshima
JapanAktiv, nicht rekrutierend» Google-Maps
University of Tsukuba Hospital
305-8576 Ibaraki
JapanAktiv, nicht rekrutierend» Google-Maps
Hakuaikai Sagara Hospital/Breast Surgery
892-0833 Kagosima
JapanAktiv, nicht rekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Saitama Cancer Center
362-0806 Kitaadachi-gun
JapanAktiv, nicht rekrutierend» Google-Maps
Kumamoto Shinto General Hospital
862-8655 Kumamoto
JapanAktiv, nicht rekrutierend» Google-Maps
NHO Shikoku Cancer Center
791-0280 Matsuyama
JapanAktiv, nicht rekrutierend» Google-Maps
Aichi Cancer Center
464-8681 Nagoya-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Hyogo College of Medicine Hospital
730-8518 Nishinomiya
JapanAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization Osaka
540-0006 Osaka
JapanAktiv, nicht rekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka
JapanAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo
JapanAktiv, nicht rekrutierend» Google-Maps
Shizuoka Cancer Center
411-8777 Sunto-Gun
JapanAktiv, nicht rekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
Kanagawa Cancer Center
241-8515 Yokohama
JapanAktiv, nicht rekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Korea University Anam Hospital
02841 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Asan Medical Center - Oncology
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Isala Ziekenhuis Zwolle
8025 AB Zwolle
NetherlandsAbgeschlossen» Google-Maps
Netherlands Cancer Institute
1066 WX Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Amphia Ziekenhuis
4818 CK Breda
NetherlandsAktiv, nicht rekrutierend» Google-Maps
University Medical Center Groningen
9713 GZ Groningen
NetherlandsAbgeschlossen» Google-Maps
Maastricht University Medical Center
6229 HX Maastricht
NetherlandsAbgeschlossen» Google-Maps
Erasmus Medisch Centrum Daniel Den Hoed
3015GD Rotterdam
NetherlandsAktiv, nicht rekrutierend» Google-Maps
National University Cancer Institute, Singapore
119228 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
National Cancer Centre Singapore
169610 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Reina Sofia
14004 Cordoba
SpainAbgeschlossen» Google-Maps
Hospital General Universitario Gregorio Marañon
28007 Madrid
SpainAbgeschlossen» Google-Maps
Hospital Clinico San Carlos
28040 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario HM Sanchinarro
28050 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Virgen de la Victoria
29010 Malaga
SpainAbgeschlossen» Google-Maps
Hospital Universitario Son Espases
07120 Palma de Mallorca
SpainAktiv, nicht rekrutierend» Google-Maps
L'Institut Catala d'Oncologia
08970 Saint Joan Despi
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario de Canarias
38320 San Cristóbal de la Laguna
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Miguel Servet
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Ryhov Hospital
55185 Jonkoping
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22185 Lund
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Onkologklinike Sodersjukhuset
S-11883 Stockholm
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8400 Winterthur
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Alle anzeigen

Studien-Informationen

Detailed Description:

This study is designed to evaluate the efficacy and safety of tucatinib in combination with

T-DM1 in participants with unresectable locally-advanced or metastatic HER2+ breast cancer

who have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab

treatment is permitted, but not required. Participants will be randomized in a 1:1 manner to

receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.

While on study treatment, participants will be assessed for progression every 6 weeks for the

first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions.

Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of

consent, or study closure. After completion of study treatment and after occurrence of

disease progression, participants in both arms of the study will continue to be followed for

survival until study closure or withdrawal of consent.

Ein-/Ausschlusskriterien

- Inclusion Criteria:

- Histologically confirmed HER2+ breast carcinoma as determined by a

sponsor-designated central laboratory

- History of prior treatment with a taxane and trastuzumab in any setting,

separately or in combination

- Have progression of unresectable locally advanced/metastatic breast cancer after

last systemic therapy, or be intolerant of last systemic therapy

- Measurable or non-measurable disease assessable by RECIST v1.1

- ECOG performance status score of 0 or 1

- CNS Inclusion - Based on screening contrast brain magnetic resonance imaging

(MRI), participants must have at least one of the following:

(a) No evidence of brain metastases

(b) Untreated brain metastases not needing immediate local therapy

(c) Previously treated brain metastases

1. Brain metastases previously treated with local therapy may either be stable

since treatment or may have progressed since prior local CNS therapy,

provided that there is no clinical indication for immediate re-treatment

with local therapy

2. Participants treated with CNS local therapy for newly identified lesions or

previously treated and progressing lesions may be eligible to enroll if all

of the following criteria are met:

(i) Time since SRS is at least 7 days prior to first dose of study

treatment, time since WBRT is at least 14 days prior to first dose, or time

since surgical resection is at least 28 days.

(ii) Other sites of evaluable disease are present

3. Relevant records of any CNS treatment must be available to allow for

classification of target and non-target lesions

- Exclusion Criteria:

- Prior treatment with tucatinib, afatinib, trastuzumab deruxtecan (DS-8201a), or

any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior

treatment with lapatinib or neratinib within 12 months of starting study

treatment (except in cases where they were given for ≤21 days and was

discontinued for reasons other than disease progression or severe toxicity).

Prior treatment with pyrotinib for recurrent of mBC (except in cases where

pyrotinib was given for ≤21 days and was discontinued for reasons other than

disease progression or severe toxicity).

- CNS Exclusion - Based on screening contrast brain magnetic resonance imaging

(MRI), participants must not have any of the following:

1. Any untreated brain lesions >2 cm in size

2. Ongoing use of corticosteroids for control of symptoms of brain metastases

at a total daily dose of >2 mg of dexamethasone (or equivalent).

3. Any brain lesion thought to require immediate local therapy

4. Known or concurrent leptomeningeal disease as documented by the investigator

5. Poorly controlled generalized or complex partial seizures

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment (Time Frame - Up to approximately 5 years):
PFS per investigator is defined as the time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.



Secondary outcome:

1. Overall Survival (Time Frame - Up to approximately 5 years):
OS is defined as the time from randomization to death due to any cause.

2. PFS per RECIST v1.1 by blinded independent committee review (BICR) (Time Frame - Up to approximately 5 years):
PFS per BICR is defined as the time from the date of randomization to the centrally-reviewed documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.

3. PFS per RECIST v1.1 by investigator assessment in participants with brain metastases at baseline (PFS.BM per investigator) (Time Frame - Up to approximately 5 years):
PFS.BM is defined as the time from the date of randomization in participants with brain metastases at baseline to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.

4. PFS.BM per RECIST v1.1 by BICR (Time Frame - Up to approximately 5 years)

5. Objective response rate (ORR) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 3 years):
ORR is defined as the proportion of participants with complete response (CR) or partial response (PR) according to RECIST v1.1.

6. ORR per RECIST v1.1 by BICR (Time Frame - Up to approximately 3 years)

7. Overall survival in participants with brain metastases at baseline (OS.BM) (Time Frame - Up to approximately 5 years):
OS.BM is defined as the time from randomization to death due to any cause in participants with brain metastases at baseline.

8. Duration of response (DOR) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 5 years):
DOR is defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of disease progression or death from any cause, whichever occurs earlier.

9. DOR per RECIST v1.1 by BICR (Time Frame - Up to approximately 5 years)

10. Clinical benefit rate (CBR) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 3 years):
CBR is defined as the proportion of participants with stable disease (SD) or non-CR or non-PD for ≥6 months or best response of CR or PR according to RECIST v1.1.

11. CBR per RECIST v1.1 by BICR (Time Frame - Up to approximately 3 years)

12. Number of participants with adverse events (AEs) (Time Frame - Through 1 month following last dose; up to approximately 9 months overall per participant):
An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Studien-Arme

  • Experimental: Tucatinib + T-DM1
    Tucatinib + T-DM1
  • Active Comparator: Placebo + T-DM1
    Placebo + T-DM1

Geprüfte Regime

  • tucatinib (ONT-380):
    300mg given twice per day by mouth (orally)
  • placebo:
    Given twice per day orally
  • T-DM1 (Kadcyla):
    3.6 mg/kg given into the vein (IV; intravenously) every 21 days

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer"

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