Sonntag, 30. Juni 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
ASCENT-07

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

Rekrutierend

NCT-Nummer:
NCT05840211

Studienbeginn:
Mai 2023

Letztes Update:
21.06.2024

Wirkstoff:
Sacituzumab Govitecan-Hziy, Paclitaxel, Nab-Paclitaxel, Capecitabine

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Gilead Sciences

Collaborator:
-

Studienleiter

Gilead Study Director
Study Director
Gilead Sciences

Kontakt

Gilead Clinical Study Information Center
Kontakt:
Phone: 1-833-445-3230 (GILEAD-0)
E-Mail: GileadClinicalTrials@gilead.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 282)

University Hospital rechts der Isar Technical University of Munich
81675 Bayern
(Bayern)
GermanyRekrutierend» Google-Maps
Vivantes Klinikum am Urban
10967 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
HELIOS Klinikum Berlin-Buch
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Brustzentrum Marienhospital Bottrop
Josef-Albers-Straße 70
46236 Bottrop
DeutschlandRekrutierend» Google-Maps
Universitätsklinik Erlangen
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
SRH Wald-Klinikum Gera GmbH
07548 Gera
(Thüringen)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Hamburg-Eppendorf
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
DeutschlandRekrutierend» Google-Maps
Nationales Centrum für Tumorerkrankungen Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Darmkrebszentrum Universitätsklinikum Mannheim
Theodor-Kutzer-Ufer 1 - 3
68167 Mannheim
DeutschlandRekrutierend» Google-Maps
Universitatsklinikum Munster
48149 Munster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
LMU Klinikum der Universitat München
81377 München
(Bayern)
GermanyRekrutierend» Google-Maps
Universitäts - Frauenklinik
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
85224 Chandler
United StatesRekrutierend» Google-Maps
Los Angeles Hematology Oncology Medical Group
90017 Los Angeles
United StatesRekrutierend» Google-Maps
Stanford Cancer Institute
94305 Palo Alto
United StatesRekrutierend» Google-Maps
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
94143 San Francisco
United StatesRekrutierend» Google-Maps
Rocky Mountain Cancer Centers, LLP
80120 Littleton
United StatesRekrutierend» Google-Maps
Yale-New Haven Hospital-Yale Cancer Center
06510 New Haven
United StatesRekrutierend» Google-Maps
Investigational Drug Services, AdventHealth Orlando
32701 Altamonte Springs
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
34613 Brooksville
United StatesRekrutierend» Google-Maps
Florida Cancer Specialist
34748 Leesburg
United StatesRekrutierend» Google-Maps
Florida Cancer Specialist
33705 Saint Petersburg
United StatesRekrutierend» Google-Maps
Piedmont Cancer Institute
30318 Atlanta
United StatesRekrutierend» Google-Maps
Georgia Cancer Specialist - Annex
30341 Atlanta
United StatesRekrutierend» Google-Maps
Northwest Georgia Oncology Centers
30060 Marietta
United StatesRekrutierend» Google-Maps
The University of Kansas Hospital
66160 Kansas City
United StatesRekrutierend» Google-Maps
Hematology Oncology Clinic
70809 Baton Rouge
United StatesRekrutierend» Google-Maps
Saint Luke's Cancer Institute
64110 Kansas City
United StatesRekrutierend» Google-Maps
David C. Pratt Cancer Center
63141 Saint Louis
United StatesRekrutierend» Google-Maps
Astera Cancer Care
08816 East Brunswick
United StatesRekrutierend» Google-Maps
Rutgers Cancer Institute of New Jersey
08901 New Brunswick
United StatesRekrutierend» Google-Maps
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
10065 New York
United StatesRekrutierend» Google-Maps
Penn State Cancer Institute
17033 Hershey
United StatesRekrutierend» Google-Maps
Magee-Womens of UPMC
15213 Pittsburgh
United StatesRekrutierend» Google-Maps
Prisma Health - Upstate
29605 Greenville
United StatesRekrutierend» Google-Maps
Tennessee Oncology, PLLC
37203 Nashville
United StatesRekrutierend» Google-Maps
Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center
37203 Nashville
United StatesRekrutierend» Google-Maps
US Oncology Investigational Products Center (IPC)
22031 Fairfax
United StatesRekrutierend» Google-Maps
US Oncology Investigational Products Center (IPC)
23502 Norfolk
United StatesRekrutierend» Google-Maps
MultiCare Regional Cancer Center - Auburn
98001 Auburn
United StatesRekrutierend» Google-Maps
Hospital Britanico de Buenos Aires
1426 Buenos Aires
ArgentinaRekrutierend» Google-Maps
Instituto de Investigaciones Clinicas de Mar del Plata
B7600 Buenos Aires
ArgentinaRekrutierend» Google-Maps
Instituto Alexander Fleming
1426ANZ C.a.b.a.
ArgentinaRekrutierend» Google-Maps
Centro Privado de RMI Rio Cuarto S.A.
5800 Cordoba
ArgentinaRekrutierend» Google-Maps
Instituto de Oncología de Rosario
2000 Rosario
ArgentinaRekrutierend» Google-Maps
CER San Juan Centro Polivalente de Asistencia e Investigación Clínica
5400 San Juan
ArgentinaRekrutierend» Google-Maps
Royal Brisbane and Women's Hospital
4029 Queensland
AustraliaRekrutierend» Google-Maps
St Vincent's Hospital Sydney
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps
GenesisCare North Shore (Oncology)
2065 St Leonards
AustraliaRekrutierend» Google-Maps
Icon Cancer Centre Wesley
4066 Auchenflower
AustraliaRekrutierend» Google-Maps
Flinders Medical Centre
5042 Bedford Park
AustraliaRekrutierend» Google-Maps
Sunshine Hospital (Western Health)
3021 St Albans
AustraliaRekrutierend» Google-Maps
Breast Cancer Research Centre - WA
6009 Nedlands
AustraliaRekrutierend» Google-Maps
University Hospital Innsbruck
06020 Innsbruck
AustriaRekrutierend» Google-Maps
Universitätsklinik für Innere Medizin 3 der PMU
A-5020 Salzburg
AustriaRekrutierend» Google-Maps
Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie
1090 Wien
AustriaRekrutierend» Google-Maps
GZA Ziekenhuizen - Campus Sint-Augustinus
2610 Antwerpen
BelgiumRekrutierend» Google-Maps
Cliniques Universitaires Saint-Luc
1200 Brussels
BelgiumRekrutierend» Google-Maps
Universitaire Ziekenhuis Leuven
3000 Leuven
BelgiumRekrutierend» Google-Maps
CHU UCL Namur-Site STE. Elisabeth
5000 Namur
BelgiumRekrutierend» Google-Maps
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
60430-230 Fortaleza
BrazilRekrutierend» Google-Maps
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
74605-070 Goiânia
BrazilRekrutierend» Google-Maps
Oncosite - Centro de Pesquisa Clinica e Oncologia
98700-000 Ijui
BrazilRekrutierend» Google-Maps
Oncoclinicas do Brasil Servicos Medicos AS
30360-680 Minas Gerais
BrazilRekrutierend» Google-Maps
Liga Norte-Rio-Grandense Contra o Câncer
59062-000 Natal
BrazilRekrutierend» Google-Maps
CIONC-Centro Integrado de Oncologia de Curitiba
80810050 Paraana
BrazilRekrutierend» Google-Maps
Hospital Erasto Gaertner
81.520-060 Paraná
BrazilRekrutierend» Google-Maps
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
50070550 Pernambuco
BrazilRekrutierend» Google-Maps
Irmandade da Santa Casa de Misericórdia de Porto Alegre
90020-090 Porto Alegre
BrazilRekrutierend» Google-Maps
Hospital de Clínicas de Porto Alegre - HCPA
90035-903 Porto Alegre
BrazilRekrutierend» Google-Maps
HGB - Hospital Giovanni Battista/Mãe de Deus Center
90110-270 Porto Alegre
BrazilRekrutierend» Google-Maps
Hospital São Lucas da PUCRS
90610001 Porto Alegre
BrazilRekrutierend» Google-Maps
Instituto Americas
22775-001 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Clínica de Oncologia de Porto Alegre Ltda - CLINIONCO
90430-090 Rio Grande Do Sul
BrazilRekrutierend» Google-Maps
Unidade de PesquisasClinicas em Oncologia - UPCO
96020-080 Rio Grande Do Sul
BrazilRekrutierend» Google-Maps
Instituto do Câncer - Hospital São Vicente de Paulo
99010-090 Rio Grande Do Sul
BrazilRekrutierend» Google-Maps
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
09060-650 Santo Andre
BrazilRekrutierend» Google-Maps
Instituto Hemomed Oncologia e Hematologia
01236-030 São Paulo
BrazilRekrutierend» Google-Maps
Clinica de pesquisa e centro de estudos em oncologia ginecológica e mamaria
1317000 São Paulo
BrazilRekrutierend» Google-Maps
The Ottawa Hospital Cancer Centre
K1H 8L6 Ottawa
CanadaRekrutierend» Google-Maps
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
G1S 4L8 Quebec
CanadaRekrutierend» Google-Maps
Centro de Investigacion Clinica Bradford Hill
Recoleta
ChileRekrutierend» Google-Maps
Centro del Cancer UC
7550000 Region Metropolitana
ChileRekrutierend» Google-Maps
Centro de Oncología de Precisión (COP)
8330032 Santiago Region
ChileRekrutierend» Google-Maps
James Lind Centro de Investigacion del Cancer
Temuco
ChileRekrutierend» Google-Maps
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
230001 Anhui
ChinaRekrutierend» Google-Maps
Peking University People's Hospital
100044 Beijing
ChinaRekrutierend» Google-Maps
The First Hospital of Jilin University
130021 Changchun
ChinaRekrutierend» Google-Maps
Xiangya Hospital Central South University
410008 Changsha
ChinaRekrutierend» Google-Maps
West China Hospital Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-Maps
Chongqing University Cancer Hospital
404100 Chongqing
ChinaRekrutierend» Google-Maps
Fujian Medical University Union Hospital
350001 Fuzhou
ChinaRekrutierend» Google-Maps
Sun Yat-Sen University Cancer Center
510060 Guangdong
ChinaRekrutierend» Google-Maps
Guangdong Provincial People's Hospital
510080 Guangzhou
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Sun Yat-sen University
510080 Guangzhou
ChinaRekrutierend» Google-Maps
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
510120 Guangzhou
ChinaRekrutierend» Google-Maps
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
310000 Hangzhou
ChinaRekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Heilongjiang
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Soochow University
215004 Jiangsu
ChinaRekrutierend» Google-Maps
The Second Hospital of Jilin University
130041 Jilin Sheng
ChinaRekrutierend» Google-Maps
Affiliated Cancer Hospital of Shandong First Medical University
250117 Jinan
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Nanchang University
330006 Nanchang
ChinaRekrutierend» Google-Maps
General Hospital of Ningxia Medical University
750004 Ningxia Hui
ChinaRekrutierend» Google-Maps
The Affiliated Hospital Of Qingdao University
266071 Qingdao
ChinaRekrutierend» Google-Maps
Fudan University Shanghai Cancer Center
200030 Shanghai
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
The Second Affiliated Hospital of Zhejiang University School of Medicine
310009 Zhejiang
ChinaRekrutierend» Google-Maps
Masaryk Memorial Cancer Institute
656 53 Brno
CzechiaRekrutierend» Google-Maps
University Hospital Olomouc
779 00 Olomouc
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice v Motole
14059 Prague 4
CzechiaRekrutierend» Google-Maps
Charles General University Hospital, Prague
12808 Prague
CzechiaRekrutierend» Google-Maps
Krajska nemocnice Tomase Bati Zlin
760 01 Zlin
CzechiaRekrutierend» Google-Maps
Centre Georges François Leclerc
21000 Dijon
FranceRekrutierend» Google-Maps
Ico René Gauducheau
44 805 Loire Atlantique
FranceRekrutierend» Google-Maps
Institut Regional du Cancer de Montpellier
34298 Montpellier Cedex 5
FranceRekrutierend» Google-Maps
Centre Hospitalier Lyon-Sud
69310 Pierre-benite
FranceRekrutierend» Google-Maps
Hopital Privé des Cotes d'Armor
22190 Plerin
FranceRekrutierend» Google-Maps
Centre Jean Bernard Service d'Oncologie Médicale
35042 Rennes Cedex
FranceRekrutierend» Google-Maps
Institut Universitaire du Cancer de Toulouse Oncopole
31059 Toulouse Cedex 9
FranceRekrutierend» Google-Maps
University Hospital of Larissa
41110 Larissa
GreeceRekrutierend» Google-Maps
University Hospital of Patras
26 500 Patras
GreeceRekrutierend» Google-Maps
Bioclinic of Thessaloniki
546 22 Thessaloniki
GreeceRekrutierend» Google-Maps
Euromedica General Clinic of Thessaloniki
546 45 Thessaloniki
GreeceRekrutierend» Google-Maps
Hong Kong Integrated Oncology Centre
Hong Kong
Hong KongRekrutierend» Google-Maps
Prince of Wales Hospital
New Territories
Hong KongRekrutierend» Google-Maps
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
1083 Budapest
HungaryRekrutierend» Google-Maps
Debreceni Egyetem Klinikai Központ
4032 Debrecen
HungaryRekrutierend» Google-Maps
Bács-Kiskun Varmegyei Oktatokorhaz, Onkaradiologiai Kozpont
6000 Kecskemét
HungaryRekrutierend» Google-Maps
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Onkoradiologia
4400 Nyiregyhaza
HungaryRekrutierend» Google-Maps
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
6720 Szeged
HungaryRekrutierend» Google-Maps
Oncology Institute Rambam Health Care Campus
31096 Haifa
IsraelRekrutierend» Google-Maps
Shaare Zedek Medical Center
9103102 Jerusalem
IsraelRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center
64239 Tel Aviv
IsraelRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
60126 Ancona AN
ItalyRekrutierend» Google-Maps
Centro di Riferimento Oncologico - IRCCS
33081 Aviano
ItalyRekrutierend» Google-Maps
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
Bologna
ItalyRekrutierend» Google-Maps
Humanitas Istituto Clinico Catanese
95045 Catania
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Mater Domini
88100 Catanzaro
ItalyRekrutierend» Google-Maps
IRCCS Ospedale Policlinico San Martino
16132 Genova GE
ItalyRekrutierend» Google-Maps
Fondazione IRCCS San Raffaele del Monte Tabor
20132 Milano
ItalyRekrutierend» Google-Maps
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
80131 Napoli
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria Policlinico Umberto I
161 Roma
ItalyRekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
168 Roma
ItalyRekrutierend» Google-Maps
Juntendo University Hospital
113-8431 Bunkyo-ku
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
1040045 Chuo-ku
JapanRekrutierend» Google-Maps
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
541-8567 Chuo-ku
JapanRekrutierend» Google-Maps
National Hospital Organization Shikoku Cancer Center
791-0280 Ehime
JapanRekrutierend» Google-Maps
Fukushima Medical University Hospital
Fukushima
JapanRekrutierend» Google-Maps
Social Medical Corporation Hakuaikai Sagara Hospital
892-0833 Kagoshima-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa
JapanRekrutierend» Google-Maps
Saitama Cancer Center
362-0806 Kitaadachi-gun
JapanRekrutierend» Google-Maps
Cancer Institute Hospital of JFCR
135-8550 Koto-Ku
JapanRekrutierend» Google-Maps
Kumamoto University Hospital
860-8556 Kumamoto- shi
JapanRekrutierend» Google-Maps
Kyoto University Hospital
606-8507 Kyoto-shi
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Minami-ku
JapanRekrutierend» Google-Maps
Hiroshima City Hiroshima Citizens Hospital
730-8518 Naka-ku
JapanRekrutierend» Google-Maps
Hyogo Medical University Hospital
663-8501 Nishinomiya-shi
JapanRekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanRekrutierend» Google-Maps
Gunma Prefectural Cancer Center
373-8550 Ota
JapanRekrutierend» Google-Maps
National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo
JapanRekrutierend» Google-Maps
Center Hospital of the National Center for Global Health and Medicine
162-8655 Shinjuku-ku
JapanRekrutierend» Google-Maps
Samsung Medical Center
06351 Gangnam-Gu
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Kyungpook National University Chilgok Hospital
41404 Gyeongsangbuk-do
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam
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
University Malaya Medical Centre
59100 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps
Centro de Investigacion y Avances Medicos Especializados
77550 Cancún
MexicoRekrutierend» Google-Maps
COI Centro Oncologico Internacional S.A.P.I. de C.V.
04700 Mexico City
MexicoRekrutierend» Google-Maps
Clinica Integral Internacional de Oncologia S de RL de CV
72530 Puebla
MexicoRekrutierend» Google-Maps
Centro Medico Zambrano Hellion
64710 San Pedro Garza García
MexicoRekrutierend» Google-Maps
Centro de Atención e Investigación Clínica en Oncología
97134 Yucatán
MexicoRekrutierend» Google-Maps
Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku
80-219 Gdansk
PolandRekrutierend» Google-Maps
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o
31-826 Krakow
PolandRekrutierend» Google-Maps
Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie
19713 Lublin
PolandRekrutierend» Google-Maps
LUX MED Onkologia Sp. Zo.o.
01-748 Warszawa
PolandRekrutierend» Google-Maps
Maria Sklodowska - Curie Institute of Oncology
02-781 Warszawa
PolandRekrutierend» Google-Maps
Centro Clinico Academico - Hospital de Braga
Braga
PortugalRekrutierend» Google-Maps
Hospital da Senhora da Oliveira Guimaraes
4835-044 Guimarães
PortugalRekrutierend» Google-Maps
Centro Hospitalar de Lisboa Central, E.P.E . - Hospital de Santo Antonio dos Capuchos
1153-302 Lisbon
PortugalRekrutierend» Google-Maps
Centro Hospitalar Lisboa Norte, EPE
1649-035 Lisbon
PortugalRekrutierend» Google-Maps
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano
4464-513 Matosinhos
PortugalRekrutierend» Google-Maps
National University Hospital
119228 Singapore
SingaporeRekrutierend» Google-Maps
National Cancer Centre Singapore
169610 Singapore
SingaporeRekrutierend» Google-Maps
The Medical Oncology Centre of Rosebank
2196 Johannesburg
South AfricaRekrutierend» Google-Maps
Cape Town Oncology Trials
7570 Kraaifontein
South AfricaRekrutierend» Google-Maps
Hospital Universitari Dexeus
08028 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clinic de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari Vall D'Hebron
8035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Reina Sofia
14004 Córdoba
SpainRekrutierend» Google-Maps
Hospital General Universitario De Elche
3203 Elche
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañón
28007 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Ramón y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario de Salamanca
37002 Salamanca
SpainRekrutierend» Google-Maps
Hospital Clínico Universitario de Santiago de Compostela - CHUS
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen Macarena
41071 Sevilla
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
41013 Seville
SpainRekrutierend» Google-Maps
Instituto Valenciano De Oncologia (IVO)
46009 Valencia
SpainRekrutierend» Google-Maps
Hospital Clínico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps
Kaohsiung Chang Gung Memorial Hospital
83301 Kaohsiung City
TaiwanRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital
807 Kaohsiung
TaiwanRekrutierend» Google-Maps
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
235 New Taipei City
TaiwanRekrutierend» Google-Maps
Chi Mei Hospital, Liouying
73657 Tainan City
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital
704 Tainan
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital
11217 Taipei City
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
10048 Taipei
TaiwanRekrutierend» Google-Maps
Koo Foundation Sun Yat-Sen Cancer Center
999999 Taipei
TaiwanRekrutierend» Google-Maps
Chang Gung Memorial Hospital, Linkou
33305 Taoyuan City
TaiwanRekrutierend» Google-Maps
Barts Cancer Institute
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
University College London Hospitals
NW1 2PG London
United KingdomRekrutierend» Google-Maps
The Royal Marsden NHS Foundation Trust
SW10 9NH London
United KingdomRekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomRekrutierend» Google-Maps
Nottingham University Hospitals NHS Trust
NG5 1PB Nottingham
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life

spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or

spread when compared to currently available standard treatments, such as paclitaxel,

nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative

to the treatment of physician's choice (TPC) on progression-free survival (PFS).

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

- Able to understand and give written informed consent.

- Must have adequate tumor tissue sample preferably from locally recurrent or metastatic

site.

- Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most

recently available tumor biopsy preferably from a locally recurrent or metastatic

site.

- Documented evidence of HER2- status.

- Documented PD by computed tomography (CT) or magnetic resonance imaging during or

after the most recent therapy per RECIST v1.1 criteria.

- Candidate for the first chemotherapy in the locally advanced or metastatic setting.

- Eligible for capecitabine, nab-paclitaxel, or paclitaxel.

- Individuals must have at least one of the following:

- Disease progression on at least 2 or more previous lines of endocrine therapy

(ET) with or without a targeted therapy in the metastatic setting.

- Disease recurrence while on the first 24 months of starting adjuvant ET will

be considered a line of therapy; these individuals will only require 1 line

of ET in the metastatic setting.

- Disease progression within 6 months of starting first-line ET with or without a

cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access

a CDK 4/6 inhibitor) in the metastatic setting.

- Disease recurrence while on the first 24 months of starting adjuvant ET with CDK

4/6 inhibitor and if the individual is no longer a candidate for additional ET in

the metastatic setting.

- Individuals may have received prior targeted therapies, including but not limited to

PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations),

phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations), or

mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be

candidates for additional endocrine treatment with or without targeted therapies.

- Individuals with HIV must be on antiretroviral therapy (ART) and have a

well-controlled HIV infection/disease.

- Demonstrates adequate organ function.

- Male individuals and female individuals of childbearing potential who engage in

heterosexual intercourse must agree to use protocol-specified method(s) of

contraception.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

- Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.

- Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are

candidates for curative intent therapy at the time of study enrollment.

- Current enrollment in another clinical study and use of any investigational device or

drug (drugs not marketed for any indication) either within 5 half-lives or 28 days

prior to randomization, whichever is longer.

- Use of investigational drugs in the category of Selective Estrogen Receptor

Degraders are acceptable if last dose was longer than 14 days prior to

randomization.

- Received any prior treatment (including antibody-drug conjugate (ADC)) containing a

chemotherapeutic agent targeting topoisomerase I.

- Received any prior treatment with a trophoblast cell-surface antigen 2

(Trop-2)-directed ADC.

- Have an active second malignancy.

- Have an active serious infection requiring antibiotics.

- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV).

- Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a

history of Kaposi sarcoma and/or Multicentric Castleman Disease.

- Have a positive serum pregnancy test or are breastfeeding for individuals who are

assigned female at birth.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Time Frame - Up to approximately 29 months):
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.



Secondary outcome:

1. Overall Survival (OS) (Time Frame - Until death, up to approximately 60 months):
OS is defined as the time from randomization until the date of death from any cause.

2. Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1 (Time Frame - Until progression, up to approximately 60 months):
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.

3. Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16 (Time Frame - Baseline, Week 16):
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants will be asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 4 (excellent), with a higher score representing a high QoL.

4. Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores (Time Frame - Up to approximately 60 months):
Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.

5. Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Time Frame - Until progression or death, up to approximately 60 months):
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.

6. Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1 (Time Frame - Up to approximately 60 months):
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.

7. Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1 (Time Frame - Until progression or death, up to approximately 60 months):
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).

8. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Time Frame - First dose date up to 30 days post last dose, up to approximately 60 months)

9. Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities (Time Frame - First dose date up to 30 days post last dose, up to approximately 60 months)

Studien-Arme

  • Experimental: Sacituzumab Govitecan-hziy (SG)
    Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.
  • Active Comparator: Treatment of Physician's Choice (TPC)
    Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: paclitaxel 80 mg/m^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. nab-Paclitaxel 100 mg/m^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. capecitabine at 1000-1250 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.

Geprüfte Regime

  • Sacituzumab Govitecan-hziy (Trodelvy™ / GS-0132 / IMMU-132 / ):
    Administered intravenously
  • Paclitaxel (Taxol®):
    Administered intravenously
  • Nab-paclitaxel (Abraxane®):
    Administered intravenously
  • Capecitabine (Xeloda®):
    Administered orally

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.