Freitag, 19. April 2024
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JOURNAL ONKOLOGIE – STUDIE

A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

Rekrutierend

NCT-Nummer:
NCT00781612

Studienbeginn:
Oktober 2008

Letztes Update:
18.04.2024

Wirkstoff:
Docetaxel, Paclitaxel, Pertuzumab, Trastuzumab, Trastuzumab Emtansine, Atezolizumab

Indikation (Clinical Trials):
Neoplasm Metastasis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Genentech, Inc.

Collaborator:
Hoffmann-La Roche

Studienleiter

Clinical Trials
Study Director
Genentech, Inc.

Kontakt

Reference Study ID Number: BO25430 https://forpatients.roche.com/
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 228)

Studienzentrum Aschaffenburg
63739 Aschaffenburg
(Bayern)
GermanyAbgeschlossen» Google-Maps
HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe
13125 Berlin
(Berlin)
GermanyAbgeschlossen» Google-Maps
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
14169 Berlin
(Berlin)
GermanyAbgeschlossen» Google-Maps
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
45136 Essen
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln
50931 Köln
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Rotkreuzklinikum München; Frauenklinik
80637 Muenchen
(Bayern)
GermanyAbgeschlossen» Google-Maps
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
81377 Muenchen
(Bayern)
GermanyAbgeschlossen» Google-Maps
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
18439 Stralsund
(Mecklenburg-Vorpommern)
GermanyAbgeschlossen» Google-Maps
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
97080 Würzburg
(Bayern)
GermanyZurückgezogen» Google-Maps
City of Hope National Medical Center
91010 Duarte
United StatesAbgeschlossen» Google-Maps
Can Care Assoc Med Group Inc; Beach Cities Offices
90095-1772 Los Angeles
United StatesAbgeschlossen» Google-Maps
Comp Cancer Centers of Nevada
90095-1772 Los Angeles
United StatesAbgeschlossen» Google-Maps
Univ of Calif, San Francisco; Breast Cancer Center
94115 San Francisco
United StatesAbgeschlossen» Google-Maps
Central Coast Medical Oncology
93454 Santa Maria
United StatesAbgeschlossen» Google-Maps
UCLA Oncology Office; Oncology
90404 Santa Monica
United StatesAbgeschlossen» Google-Maps
Stanford Cancer Institute
94305 Stanford
United StatesAbgeschlossen» Google-Maps
Kaiser Permanente; Oncology Clinical Trials
94589 Vallejo
United StatesAbgeschlossen» Google-Maps
Kaiser Permanente - Walnut Creek
94596 Walnut Creek
United StatesAbgeschlossen» Google-Maps
Univ of Colorado Canc Ctr
80045 Aurora
United StatesAbgeschlossen» Google-Maps
University of Colorado
80045 Aurora
United StatesAbgeschlossen» Google-Maps
Rocky Mountain Cancer Center - Denver
80120 Littleton
United StatesAbgeschlossen» Google-Maps
Christina Care Institutional Review Board
18713 Newark
United StatesAbgeschlossen» Google-Maps
Florida Cancer Specialists; Department of Oncology
33901-8101 Fort Myers
United StatesAbgeschlossen» Google-Maps
Baptist - MD Anderson Cancer Center
32207 Jacksonville
United StatesZurückgezogen» Google-Maps
Univ of Miami Health Systems
33136 Miami
United StatesZurückgezogen» Google-Maps
Memorial Cancer Institute at Memorial West
33028 Pembroke Pines
United StatesAbgeschlossen» Google-Maps
Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
33705 Saint Petersburg
United StatesAbgeschlossen» Google-Maps
Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
33607 Tampa
United StatesAbgeschlossen» Google-Maps
Northwest Georgia Oncology Centers PC - Marietta
30060 Marietta
United StatesAbgeschlossen» Google-Maps
Kootenai Cancer Center
83854 Post Falls
United StatesAbgeschlossen» Google-Maps
Loyola University Med Center
60153 Maywood
United StatesAbgeschlossen» Google-Maps
Midwestern Regional Medical Center; Office of Research
60099 Zion
United StatesAbgeschlossen» Google-Maps
Indiana University Melvin and Bren Simon Cancer Center
46202 Indianapolis
United StatesAbgeschlossen» Google-Maps
Hematology-Oncology; Associates of the Quad Cities
52722 Bettendorf
United StatesAbgeschlossen» Google-Maps
Oncology Assoc of Cedar Rapids; Iowa Cancer Care
52403 Cedar Rapids
United StatesAbgeschlossen» Google-Maps
Cancer Center of Kansas
67214-3728 Wichita
United StatesZurückgezogen» Google-Maps
New England Cancer Specialists
04074 Scarborough
United StatesZurückgezogen» Google-Maps
Anne Arundel Medical Center; Anne Arundel Health System
21401 Annapolis
United StatesAbgeschlossen» Google-Maps
Johns Hopkins Univ Med Center
21231 Baltimore
United StatesAbgeschlossen» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesAbgeschlossen» Google-Maps
Dana Farber Cancer Institute; Breast Oncology
02115 Boston
United StatesAbgeschlossen» Google-Maps
Karmanos Cancer Institute
48201 Detroit
United StatesAbgeschlossen» Google-Maps
Minnesota Oncology Hematology, Pa
55407 Minneapolis
United StatesAbgeschlossen» Google-Maps
University of Minnesota.
55454 Minneapolis
United StatesAbgeschlossen» Google-Maps
Mayo Clinic - Rochester
55905 Rochester
United StatesAbgeschlossen» Google-Maps
Capitol Comprehensive CA Care
65101 Jefferson City
United StatesZurückgezogen» Google-Maps
St. John's Mercy Medical Ctr; David C. Pratt Cancer Center
63141 Saint Louis
United StatesAbgeschlossen» Google-Maps
Mercy Clinic Cancer & Hematology
65804 Springfield
United StatesAbgeschlossen» Google-Maps
St. Barnabas Health Care Sys
07039 Livingston
United StatesAbgeschlossen» Google-Maps
NS-Long Island Jewish Hlth Sys
11042 Lake Success
United StatesAbgeschlossen» Google-Maps
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
10016 New York
United StatesAbgeschlossen» Google-Maps
Memorial Sloan-Kettering Cancer Center
10065 New York
United StatesAbgeschlossen» Google-Maps
Clinical Research Alliance
11590 Westbury
United StatesAbgeschlossen» Google-Maps
Carolina Oncology Specialists, PA - Hickory
28602 Hickory
United StatesAbgeschlossen» Google-Maps
The Cleveland Clinic Foundation
44195 Cleveland
United StatesAbgeschlossen» Google-Maps
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
43219 Columbus
United StatesAbgeschlossen» Google-Maps
Northwest Cancer Specialists - Portland (N Broadway)
97227 Portland
United StatesAbgeschlossen» Google-Maps
Fox Chase Cancer Center
19111 Philadelphia
United StatesAbgeschlossen» Google-Maps
Sarah Cannon Research Institute / Tennessee Oncology
37404 Chattanooga
United StatesAbgeschlossen» Google-Maps
Sarah Cannon Research Institute / Tennessee Oncology
38138 Germantown
United StatesAbgeschlossen» Google-Maps
Vanderbilt Ingram Cancer Ctr
37232 Nashville
United StatesZurückgezogen» Google-Maps
Texas Oncology - Dallas Presbyterian Hospital
75231 Dallas
United StatesAbgeschlossen» Google-Maps
Millennium Research & Clinical Development
77090 Houston
United StatesZurückgezogen» Google-Maps
US Oncology Research Pharm.
75063 Irving
United StatesZurückgezogen» Google-Maps
Cancer Therapy & Research Center
78229 San Antonio
United StatesAbgeschlossen» Google-Maps
US Oncology Research, Inc.
77380 The Woodlands
United StatesZurückgezogen» Google-Maps
Univ of WA Medical Center
98109 Seattle
United StatesAbgeschlossen» Google-Maps
Uni of Washington Medical Center; Dept of Oncology
98195 Seattle
United StatesAbgeschlossen» Google-Maps
Northwest Medical Specialties
98405 Tacoma
United StatesAbgeschlossen» Google-Maps
Peninsula and South Eastern Haematology and Oncology Group
3199 Frankston
AustraliaAbgebrochen» Google-Maps
Peter MacCallum Cancer Center
3051 North Melbourne
AustraliaAbgeschlossen» Google-Maps
Klinik Favoriten; 1 Medizinische Abteilung
1100 Wien
AustriaZurückgezogen» Google-Maps
Sint Augustinus Wilrijk, Apotheek
2610 Wilrijk
BelgiumAbgeschlossen» Google-Maps
Nucleo de Oncologia da Bahia - NOB
40170-380 Salvador, Bahia
BrazilZurückgezogen» Google-Maps
Trymed Clinical Research
30150-281 Belo Horizonte
BrazilZurückgezogen» Google-Maps
Instituto Nacional de Cancer - INCa; Oncologia
20560-120 Rio de Janeiro
BrazilAbgeschlossen» Google-Maps
Santa Casa de Misericordia de Porto Alegre
90020-090 Porto Alegre
BrazilZurückgezogen» Google-Maps
Hospital Nossa Senhora da Conceicao
90040-373 Porto Alegre
BrazilAbgeschlossen» Google-Maps
Clinica de Oncologia de Porto Alegre - CliniOnco
90430-090 Porto Alegre
BrazilAbgeschlossen» Google-Maps
Hospital Sao Lucas - PUCRS
90610-000 Porto Alegre
BrazilZurückgezogen» Google-Maps
Clinica de Neoplasias Litoral
88301-220 Itajai
BrazilAbgeschlossen» Google-Maps
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
09060-650 Santo Andre
BrazilAbgeschlossen» Google-Maps
Hospital Perola Byington
01317-000 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
4004 Plovdiv
BulgariaAbgeschlossen» Google-Maps
BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
V1Y 5L3 Kelowna
CanadaAbgeschlossen» Google-Maps
Ottawa Regional Cancer Centre; Civic Hospital Division
K1H 8L6 Ottawa
CanadaAbgeschlossen» Google-Maps
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
M5G 2M9 Toronto
CanadaAbgeschlossen» Google-Maps
Centre Hospitalier de l?Université de Montréal (CHUM)
H2X 0C2 Montreal
CanadaAbgeschlossen» Google-Maps
Saskatoon Cancer Centre
SK S7N 4H4 Saskatoon
CanadaAbgeschlossen» Google-Maps
CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY
G1S 4L8 Quebec
CanadaAbgeschlossen» Google-Maps
Fundacion Arturo Lopez Perez
7500921 Santiago
ChileAbgeschlossen» Google-Maps
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
100071 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps
Beijing Cancer Hospital
100142 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps
the First Hospital of Jilin University
130021 Changchun
ChinaAktiv, nicht rekrutierend» Google-Maps
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center
510120 Guangzhou City
ChinaRekrutierend» Google-Maps
Sun Yet-sen University Cancer Center
510663 Guangzhou City
ChinaAktiv, nicht rekrutierend» Google-Maps
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
310022 Hangzhou City
ChinaAktiv, nicht rekrutierend» Google-Maps
Zhejiang Provincial People's Hospital; Oncology& Breast
310014 Hangzhou
ChinaRekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaAktiv, nicht rekrutierend» Google-Maps
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
210029 Nanjing City
ChinaAbgeschlossen» Google-Maps
Jiangsu Cancer Hospital
211100 Nanjing City
ChinaAktiv, nicht rekrutierend» Google-Maps
Fudan University Shanghai Cancer Center
200120 Shanghai City
ChinaRekrutierend» Google-Maps
Clinical Hospital Centre Zagreb
10000 Zagreb
CroatiaZurückgezogen» Google-Maps
Fakultni nemocnice Olomouc; Onkologicka klinika
779 00 Olomouc
CzechiaAbgeschlossen» Google-Maps
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
128 08 Praha 2
CzechiaAbgeschlossen» Google-Maps
Odense Universitetshospital, Onkologisk Afdeling R
5000 Odense C
DenmarkAbgeschlossen» Google-Maps
Vejle Sygehus; Onkologisk Afdeling
7100 Vejle
DenmarkAbgeschlossen» Google-Maps
Centre Francois Baclesse; Comite Sein
14076 Caen
FranceAbgeschlossen» Google-Maps
Centre Georges Francois Leclerc; Oncologie 3
21079 Dijon
FranceAbgeschlossen» Google-Maps
Centre Hospitalier Departemental Les Oudairies
85925 La Roche Sur Yon
FranceZurückgezogen» Google-Maps
Institut Paoli Calmettes; Oncologie Medicale
13273 Marseille
FranceAbgeschlossen» Google-Maps
Institut régional du Cancer Montpellier
34298 Montpellier
FranceAbgeschlossen» Google-Maps
Institut Curie; Oncologie Medicale
75231 Paris
FranceAbgeschlossen» Google-Maps
Ico Rene Gauducheau; Oncologie
44805 Saint Herblain
FranceAbgeschlossen» Google-Maps
Institut Curie - Hopital Rene Huguenin
92211 Saint-Cloud
FranceAktiv, nicht rekrutierend» Google-Maps
Queen Mary Hospital; Dept of Medicine
Hong Kong
Hong KongAbgeschlossen» Google-Maps
Szent Margit Hospital; Dept. of Oncology
1032 Budapest
HungaryAbgeschlossen» Google-Maps
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
1125 Budapest
HungaryZurückgezogen» Google-Maps
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
4032 Debrecen
HungaryAbgeschlossen» Google-Maps
Shaare Zedek Medical Center
9103102 Jerusalem
IsraelAbgeschlossen» Google-Maps
Kaplan Medical Center; Oncology Inst.
7610001 Rehovot
IsraelZurückgezogen» Google-Maps
Tel Aviv Sourasky Medical Ctr; Oncology
6423906 Tel Aviv
IsraelAbgeschlossen» Google-Maps
Ospedale San Carlo; Day Hospital Oncologia Medica
85100 Potenza
ItalyAbgeschlossen» Google-Maps
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
88100 Catanzaro
ItalyAbgeschlossen» Google-Maps
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
80131 Napoli
ItalyAbgeschlossen» Google-Maps
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
47014 Meldola
ItalyAbgeschlossen» Google-Maps
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
47014 Meldola
ItalyZurückgezogen» Google-Maps
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
43100 Parma
ItalyAbgeschlossen» Google-Maps
RCCS - Centro di Riferimento; Oncologia Medica B
33081 Aviano (PN)
ItalyAbgeschlossen» Google-Maps
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
33100 Udine
ItalyAbgeschlossen» Google-Maps
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
20133 Milano
ItalyAbgeschlossen» Google-Maps
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
10060 Candiolo
ItalyAbgeschlossen» Google-Maps
Ospedale Civile; Oncologia Medica
07100 Sassari
ItalyAbgeschlossen» Google-Maps
Humanitas Istituto Clinico Catanese S.p.A
95045 Misterbianco (CT)
ItalyAbgeschlossen» Google-Maps
A.O. Universitaria Pisana; Oncologia
56100 Pisa
ItalyZurückgezogen» Google-Maps
Ospedale Misericordia E Dolce; Oncologia Medica
59100 Prato
ItalyZurückgezogen» Google-Maps
Hiroshima University Hospital; Breast Surgery
734-8551 Hiroshima
JapanAbgeschlossen» Google-Maps
Hyogo Cancer Center; Breast Surgery
673-8558 Hyogo
JapanAbgeschlossen» Google-Maps
Saitama Medical University International Medical Center; Breast Oncology
350-1298 Saitama
JapanZurückgezogen» Google-Maps
Kyungpook National University Medical Center; Oncology
702-210 Daegu
Korea, Republic ofAbgeschlossen» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofAbgeschlossen» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofAbgeschlossen» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Seoul National University Hospital; Department of Oncology
110-744 Seoul
Korea, Republic ofZurückgezogen» Google-Maps
Centro de Investigacion; Clinica Del Pacifico
39670 Acapulco
MexicoAbgeschlossen» Google-Maps
Consultorio de Medicina Especializada
03100 Mexico
MexicoAbgeschlossen» Google-Maps
Oaxaca Site Management Organization
68000 Oaxaca de Juárez
MexicoZurückgezogen» Google-Maps
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
1023 Auckland
New ZealandAbgeschlossen» Google-Maps
Private Health Organization Acibadem Sistina Hospital
1000 Skopje
North MacedoniaAbgeschlossen» Google-Maps
Oslo Universitetssykehus HF; Radiumhospitalet
0310 Oslo
NorwayAbgeschlossen» Google-Maps
Instituto Nacional de Enfermedades Neoplasicas
Lima 34 Lima
PeruAktiv, nicht rekrutierend» Google-Maps
Cebu Cancer Institute; Perpetual Succour Hospital
6000 Cebu City
PhilippinesAbgeschlossen» Google-Maps
Veterans Memorial Medical Ctr; Cancer Research Centre
1101 Quezon City
PhilippinesAbgeschlossen» Google-Maps
Cardinal Santos Medical Center
1502 San Juan
PhilippinesAbgeschlossen» Google-Maps
Uniwersyteckie Centrum Kliniczne
Gdansk
PolandAktiv, nicht rekrutierend» Google-Maps
?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii
25-734 Kielce
PolandAktiv, nicht rekrutierend» Google-Maps
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
20-090 Lublin
PolandZurückgezogen» Google-Maps
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
05-400 Otwock
PolandAbgeschlossen» Google-Maps
Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii
61-866 Poznan
PolandAktiv, nicht rekrutierend» Google-Maps
Wojewódzki Szpital Specjalistyczny Nr 3
44-200 Rybnik
PolandAktiv, nicht rekrutierend» Google-Maps
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
02-781 Warszawa
PolandAktiv, nicht rekrutierend» Google-Maps
Hospital da Luz; Departamento de Oncologia Medica
1500-650 Lisboa
PortugalAbgeschlossen» Google-Maps
Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
4099-001 Porto
PortugalAktiv, nicht rekrutierend» Google-Maps
IPO do Porto; Servico de Oncologia Medica
4200-072 Porto
PortugalAktiv, nicht rekrutierend» Google-Maps
Bashkirian Republican Clinical Oncology Dispensary
450054 UFA
Russian FederationAbgeschlossen» Google-Maps
City Clinical Oncology Hospital
143423 Moscow
Russian FederationAbgeschlossen» Google-Maps
Blokhin Cancer Research Center; Combined Treatment
115478 Moskva
Russian FederationAbgeschlossen» Google-Maps
FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF
197758 St Petersburg
Russian FederationAbgeschlossen» Google-Maps
City Oncology Dispensary
St Petersburg
Russian FederationAbgeschlossen» Google-Maps
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
355045 Stavropol
Russian FederationAbgeschlossen» Google-Maps
National University Hospital; National University Cancer Institute, Singapore (NCIS)
119228 Singapore
SingaporeZurückgezogen» Google-Maps
Institute of Oncology Ljubljana
1000 Ljubljana
SloveniaAbgeschlossen» Google-Maps
Hospital General Universitario de Elche; Servicio de Oncologia
03203 Elche
SpainAbgeschlossen» Google-Maps
Hospital Univ Vall d'Hebron; Servicio de Oncologia
08740 Sant Andreu de La Barca
SpainAbgeschlossen» Google-Maps
Hospital de Jerez de la Frontera; Servicio de Oncologia
11407 Jerez de La Frontera
SpainAbgeschlossen» Google-Maps
Hospital de Donostia; Servicio de Oncologia Medica
20080 San Sebastian
SpainAbgeschlossen» Google-Maps
Hospital Severo Ochoa; Servicio de Oncologia
28911 Leganes
SpainZurückgezogen» Google-Maps
Hospital del Mar; Servicio de Oncologia
08003 Barcelona
SpainAbgeschlossen» Google-Maps
Hospital Duran i Reynals; Oncologia
08907 Barcelona
SpainAbgeschlossen» Google-Maps
Hospital San Pedro De Alcantara; Servicio de Oncologia
10003 Caceres
SpainAbgeschlossen» Google-Maps
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
25198 Lerida
SpainAbgeschlossen» Google-Maps
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
28007 Madrid
SpainAbgeschlossen» Google-Maps
Hospital Ramon y Cajal; Servicio de Oncologia
28034 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario La Paz; Servicio de Oncologia
28046 Madrid
SpainZurückgezogen» Google-Maps
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
41013 Sevilla
SpainZurückgezogen» Google-Maps
Hospital Universitario Miguel Servet; Servicio Oncologia
50009 Zaragoza
SpainAbgeschlossen» Google-Maps
Mälarsjukhuset; Onkologkliniken Sörmland
63188 Eskilstuna
SwedenAbgeschlossen» Google-Maps
Universitätsspital Zürich
8091 Zürich
SwitzerlandAbgeschlossen» Google-Maps
National Cheng Kung Uni Hospital; Surgery
704 Tainan
TaiwanZurückgezogen» Google-Maps
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
11259 Taipei City
TaiwanZurückgezogen» Google-Maps
National Taiwan Uni Hospital; Dept of Oncology
100 Taipei
TaiwanAbgeschlossen» Google-Maps
Chang Gung Memorial Hospital - Linkou
333 Taoyuan
TaiwanZurückgezogen» Google-Maps
Bumrungrad International Hosp
10110 Bangkok
ThailandAbgeschlossen» Google-Maps
Rajavithi Hospital; Division of Medical Oncology
10400 Bangkok
ThailandAbgebrochen» Google-Maps
Ninewells Hospital
DD12 9SY Dundee
United KingdomAbgeschlossen» Google-Maps
Western General Hospital; Clinical Oncology
EH4 2XU Edinburgh
United KingdomAbgeschlossen» Google-Maps
Diana Princess of Wales Hosp.
DN33 2BA Grimsby
United KingdomAbgeschlossen» Google-Maps
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
LA1 4RP Lancaster
United KingdomAbgeschlossen» Google-Maps
Royal Free Hospital; Dept of Oncology
NW3 2QG London
United KingdomAbgeschlossen» Google-Maps
Christie Hospital NHS Trust
M20 4BX Manchester
United KingdomAbgeschlossen» Google-Maps
Mount Vernon Hospital
HA6 2RN Middlesex
United KingdomAbgeschlossen» Google-Maps
Mount Vernon Cancer Centre
HA6 2RN Northwood
United KingdomZurückgezogen» Google-Maps
Nottingham City Hospital; Oncology
NG5 1PB Nottingham
United KingdomAbgeschlossen» Google-Maps
Poole General Hospital
BH15 2JB Poole
United KingdomAbgeschlossen» Google-Maps
Queen's Hospital; Oncology
RM7 0AG Romford
United KingdomAbgeschlossen» Google-Maps
Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute
SA6 6NL Swansea
United KingdomAbgeschlossen» Google-Maps
Royal Cornwall Hospital
TR1 3LQ Truro
United KingdomAbgeschlossen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This is a global, multicenter, open-label safety extension study. Participants receiving

single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with

other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and

receiving benefit at the closure of parent study are eligible for continued treatment in this

study.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine

treatment in the parent study or who continue to receive single-agent trastuzumab

emtansine or combination trastuzumab emtansine treatment at the time of the parent

study closure and received the last study drug dose within the 6 weeks (42 days) prior

to the first dose of study therapy on the extension study or Continue to receive

treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of

the parent study closure if the participant received the last dose of control arm

study drug within the 6 weeks (42 days) prior to the first dose of control arm study

therapy in the extension study

- Participants in the control arm from Study BO21976/TDM4450g whose disease progression

has occurred during the transition interval between the parent study and this

extension study may initiate trastuzumab emtansine treatment at the time of enrollment

into study TDM4529g (NCT00781612)

- Expectation by the investigator that the participant may continue to benefit from

additional single-agent trastuzumab emtansine or combination trastuzumab emtansine

treatment or Expectation of the investigator that the participant may continue to

benefit from control arm treatment as given in study BO21976/TDM4450g and at the time

of disease progression may benefit from single-agent trastuzumab emtansine treatment

- Women of childbearing potential and men with partners of childbearing potential, must

be willing to use a highly effective form of non-hormonal contraception or two

effective forms of non-hormonal contraception by the participants and/or partner, and

to continue the use of contraception for the duration of study treatment and for at

least 5 months after the final dose of atezolizumab (if applicable) or 7 months after

the final dose of trastuzumab, trastuzumab emtansine or pertuzumab, whichever is

later. Women must refrain from donating eggs during this same period

- Male participants whose partners are pregnant should use condoms for the duration of

the pregnancy. Men must refrain from donating sperm during this same period

Exclusion Criteria:

- AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine

treatment discontinuation in the parent study

- Ongoing SAEs from the parent study

- Progressive disease on single-agent trastuzumab emtansine or a trastuzumab

emtansine-containing regimen during the parent study or before starting the extension

study, with the exception of participants from study TDM4688g (NCT00943670) with early

disease progression who went on to receive pertuzumab + trastuzumab emtansine

treatment and have not experienced further disease progression on the combination

regimen

- Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National

Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version

3.0, 4.0 or 5.0, as utilized in the parent study

- History of symptomatic congestive heart failure ([CHF]; New York Heart Association

[NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable

angina, or history of myocardial infarction within 6 months prior to study entry

- Severe dyspnea at rest due to complications of advanced malignancy or current

requirement for continuous oxygen therapy

- Current severe, uncontrolled systemic disease (for example [e.g.] clinically

significant cardiovascular, pulmonary, or metabolic disease)

- Major surgical procedure or significant traumatic injury within 28 days prior to study

entry or anticipation of the need for major surgery during the course of study

treatment

- Current pregnancy or lactation

- History of receiving any investigational treatment or other systemic therapy directed

at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's

last study drug dose in the parent study

- History of hypersensitivity with previous trastuzumab emtansine or any agent used with

trastuzumab emtansine in the parent study, precluding further dosing

- Assessed by the investigator to be unable or unwilling to comply with the requirements

of the protocol

Studien-Rationale

Primary outcome:

1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Time Frame - Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years))

2. Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction (Time Frame - Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years))

Geprüfte Regime

  • Docetaxel:
    Docetaxel will be administered as per local prescribing information.
  • Paclitaxel:
    Paclitaxel will be administered as per local prescribing information.
  • Pertuzumab (Perjeta):
    Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).
  • Trastuzumab (Herceptin):
    Trastuzumab will be administered as per local prescribing information.
  • Trastuzumab Emtansine (Kadcyla; T-DM1):
    Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).
  • Atezolizumab (Tecentriq):
    Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)

Quelle: ClinicalTrials.gov


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"A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies"

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