Trial Title:
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
NCT ID:
NCT05840211
Condition:
Locally Advanced or Unresectable Metastatic Breast Cancer
Stage IV Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Capecitabine
Sacituzumab govitecan
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sacituzumab Govitecan-hziy
Description:
Administered intravenously
Arm group label:
Sacituzumab Govitecan-hziy (SG)
Other name:
Trodelvy™
Other name:
GS-0132
Other name:
IMMU-132
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Administered intravenously
Arm group label:
Treatment of Physician's Choice (TPC)
Other name:
Taxol®
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Administered intravenously
Arm group label:
Treatment of Physician's Choice (TPC)
Other name:
Abraxane®
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Administered orally
Arm group label:
Treatment of Physician's Choice (TPC)
Other name:
Xeloda®
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).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Address:
City:
Chandler
Zip:
85224
Country:
United States
Facility:
Name:
Los Angeles Hematology Oncology Medical Group
Address:
City:
Los Angeles
Zip:
90017
Country:
United States
Facility:
Name:
Stanford Cancer Institute
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Facility:
Name:
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Facility:
Name:
Rocky Mountain Cancer Centers, LLP
Address:
City:
Littleton
Zip:
80120
Country:
United States
Facility:
Name:
Yale-New Haven Hospital-Yale Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Facility:
Name:
Investigational Drug Services, AdventHealth Orlando
Address:
City:
Altamonte Springs
Zip:
32701
Country:
United States
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Brooksville
Zip:
34613
Country:
United States
Facility:
Name:
Florida Cancer Specialist
Address:
City:
Leesburg
Zip:
34748
Country:
United States
Facility:
Name:
Florida Cancer Specialist
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Facility:
Name:
Piedmont Cancer Institute
Address:
City:
Atlanta
Zip:
30318
Country:
United States
Facility:
Name:
Georgia Cancer Specialist - Annex
Address:
City:
Atlanta
Zip:
30341
Country:
United States
Facility:
Name:
Northwest Georgia Oncology Centers
Address:
City:
Marietta
Zip:
30060
Country:
United States
Facility:
Name:
The University of Kansas Hospital
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Facility:
Name:
Hematology Oncology Clinic
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Facility:
Name:
Saint Luke's Cancer Institute
Address:
City:
Kansas City
Zip:
64110
Country:
United States
Facility:
Name:
David C. Pratt Cancer Center
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Facility:
Name:
Astera Cancer Care
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Facility:
Name:
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Facility:
Name:
Stefanie Spielman Comprehensive Breast Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Penn State Cancer Institute
Address:
City:
Hershey
Zip:
17033
Country:
United States
Facility:
Name:
Magee-Womens of UPMC
Address:
City:
Pittsburgh
Zip:
15213
Country:
United States
Facility:
Name:
Prisma Health - Upstate
Address:
City:
Greenville
Zip:
29605
Country:
United States
Facility:
Name:
Tennessee Oncology, PLLC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Vanderbilt University Medical Center - Vanderbilt-Ingram Cancer Center
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
US Oncology Investigational Products Center (IPC)
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Facility:
Name:
US Oncology Investigational Products Center (IPC)
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Facility:
Name:
MultiCare Regional Cancer Center - Auburn
Address:
City:
Auburn
Zip:
98001
Country:
United States
Facility:
Name:
Hospital Britanico de Buenos Aires
Address:
City:
Buenos Aires
Zip:
1426
Country:
Argentina
Facility:
Name:
Instituto de Investigaciones Clinicas de Mar del Plata
Address:
City:
Buenos Aires
Zip:
B7600
Country:
Argentina
Facility:
Name:
Instituto Alexander Fleming
Address:
City:
C.a.b.a.
Zip:
1426ANZ
Country:
Argentina
Facility:
Name:
Hospital Alemán
Address:
City:
Caba
Zip:
1118
Country:
Argentina
Facility:
Name:
Centro Privado de RMI Rio Cuarto S.A.
Address:
City:
Cordoba
Zip:
5800
Country:
Argentina
Facility:
Name:
Instituto de Oncología de Rosario
Address:
City:
Rosario
Zip:
2000
Country:
Argentina
Facility:
Name:
CER San Juan Centro Polivalente de Asistencia e Investigación Clínica
Address:
City:
San Juan
Zip:
5400
Country:
Argentina
Facility:
Name:
Royal Brisbane and Women's Hospital
Address:
City:
Queensland
Zip:
4029
Country:
Australia
Facility:
Name:
St Vincent's Hospital Sydney
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Facility:
Name:
Liverpool Hospital
Address:
City:
Liverpool
Zip:
2170
Country:
Australia
Facility:
Name:
GenesisCare North Shore (Oncology)
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Facility:
Name:
Icon Cancer Centre Wesley
Address:
City:
Auchenflower
Zip:
4066
Country:
Australia
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Facility:
Name:
Icon Cancer Centre Hobart
Address:
City:
Hobart
Zip:
7000
Country:
Australia
Facility:
Name:
Austin Health
Address:
City:
Melbourne
Zip:
3084
Country:
Australia
Facility:
Name:
Sunshine Hospital (Western Health)
Address:
City:
St Albans
Zip:
3021
Country:
Australia
Facility:
Name:
Breast Cancer Research Centre - WA
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Facility:
Name:
University Hospital Innsbruck
Address:
City:
Innsbruck
Zip:
06020
Country:
Austria
Facility:
Name:
Universitätsklinik für Innere Medizin 3 der PMU
Address:
City:
Salzburg
Zip:
A-5020
Country:
Austria
Facility:
Name:
Klinikum Wels-Grieskirchen
Address:
City:
Wels
Zip:
4710
Country:
Austria
Facility:
Name:
Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie
Address:
City:
Wien
Zip:
1090
Country:
Austria
Facility:
Name:
GZA Ziekenhuizen - Campus Sint-Augustinus
Address:
City:
Antwerpen
Zip:
2610
Country:
Belgium
Facility:
Name:
AZ Klina
Address:
City:
Brasschaat
Zip:
2930
Country:
Belgium
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Facility:
Name:
Universitaire Ziekenhuis Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Facility:
Name:
CHU UCL Namur-Site STE. Elisabeth
Address:
City:
Namur
Zip:
5000
Country:
Belgium
Facility:
Name:
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
Address:
City:
Fortaleza
Zip:
60430-230
Country:
Brazil
Facility:
Name:
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
Address:
City:
Goiânia
Zip:
74605-070
Country:
Brazil
Facility:
Name:
Oncosite - Centro de Pesquisa Clinica e Oncologia
Address:
City:
Ijui
Zip:
98700-000
Country:
Brazil
Facility:
Name:
Catarina Pesquisa Clinica
Address:
City:
Itajai
Zip:
88301-220
Country:
Brazil
Facility:
Name:
Oncoclinicas do Brasil Servicos Medicos AS
Address:
City:
Minas Gerais
Zip:
30360-680
Country:
Brazil
Facility:
Name:
Liga Norte-Rio-Grandense Contra o Câncer
Address:
City:
Natal
Zip:
59062-000
Country:
Brazil
Facility:
Name:
CIONC-Centro Integrado de Oncologia de Curitiba
Address:
City:
Paraana
Zip:
80810050
Country:
Brazil
Facility:
Name:
Hospital Erasto Gaertner
Address:
City:
Paraná
Zip:
81.520-060
Country:
Brazil
Facility:
Name:
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
Address:
City:
Pernambuco
Zip:
50070550
Country:
Brazil
Facility:
Name:
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90020-090
Country:
Brazil
Facility:
Name:
Hospital de Clínicas de Porto Alegre - HCPA
Address:
City:
Porto Alegre
Zip:
90035-903
Country:
Brazil
Facility:
Name:
HGB - Hospital Giovanni Battista/Mãe de Deus Center
Address:
City:
Porto Alegre
Zip:
90110-270
Country:
Brazil
Facility:
Name:
Hospital São Lucas da PUCRS
Address:
City:
Porto Alegre
Zip:
90610001
Country:
Brazil
Facility:
Name:
Instituto Americas
Address:
City:
Rio de Janeiro
Zip:
22775-001
Country:
Brazil
Facility:
Name:
Clínica de Oncologia de Porto Alegre Ltda - CLINIONCO
Address:
City:
Rio Grande Do Sul
Zip:
90430-090
Country:
Brazil
Facility:
Name:
Unidade de PesquisasClinicas em Oncologia - UPCO
Address:
City:
Rio Grande Do Sul
Zip:
96020-080
Country:
Brazil
Facility:
Name:
Instituto do Câncer - Hospital São Vicente de Paulo
Address:
City:
Rio Grande Do Sul
Zip:
99010-090
Country:
Brazil
Facility:
Name:
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Address:
City:
Santo Andre
Zip:
09060-650
Country:
Brazil
Facility:
Name:
Instituto Hemomed Oncologia e Hematologia
Address:
City:
São Paulo
Zip:
01236-030
Country:
Brazil
Facility:
Name:
Clinica de pesquisa e centro de estudos em oncologia ginecológica e mamaria
Address:
City:
São Paulo
Zip:
1317000
Country:
Brazil
Facility:
Name:
BC Cancer - Kelowna
Address:
City:
Kelowna
Zip:
V1Y 5L3
Country:
Canada
Facility:
Name:
The Ottawa Hospital Cancer Centre
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Facility:
Name:
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
Address:
City:
Quebec
Zip:
G1S 4L8
Country:
Canada
Facility:
Name:
Humber River Hospital
Address:
City:
Toronto
Zip:
M3M 0B2
Country:
Canada
Facility:
Name:
BC Cancer-Victoria
Address:
City:
Victoria
Zip:
V8R 6V5
Country:
Canada
Facility:
Name:
Centro de Investigacion Clinica Bradford Hill
Address:
City:
Recoleta
Country:
Chile
Facility:
Name:
Centro del Cancer UC
Address:
City:
Region Metropolitana
Zip:
7550000
Country:
Chile
Facility:
Name:
Centro de Oncología de Precisión (COP)
Address:
City:
Santiago Region
Zip:
8330032
Country:
Chile
Facility:
Name:
James Lind Centro de Investigacion del Cancer
Address:
City:
Temuco
Country:
Chile
Facility:
Name:
Oncocentro APYS
Address:
City:
Vina del Mar
Zip:
2520612
Country:
Chile
Facility:
Name:
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Address:
City:
Anhui
Zip:
230001
Country:
China
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Zip:
410008
Country:
China
Facility:
Name:
West China Hospital Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
404100
Country:
China
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fujian
Zip:
350015
Country:
China
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangdong
Zip:
510060
Country:
China
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Facility:
Name:
The First Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Facility:
Name:
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Facility:
Name:
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Heilongjiang
Zip:
150081
Country:
China
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Jiangsu
Zip:
210029
Country:
China
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Jiangsu
Zip:
215004
Country:
China
Facility:
Name:
The Nanchang Third Hospital
Address:
City:
Jiangxi
Zip:
330009
Country:
China
Facility:
Name:
The Second Hospital of Jilin University
Address:
City:
Jilin Sheng
Zip:
130041
Country:
China
Facility:
Name:
Affiliated Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Zip:
250117
Country:
China
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
General Hospital of Ningxia Medical University
Address:
City:
Ningxia Hui
Zip:
750004
Country:
China
Facility:
Name:
The Affiliated Hospital Of Qingdao University
Address:
City:
Qingdao
Zip:
266071
Country:
China
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200030
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
453000
Country:
China
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Zhejiang
Zip:
310009
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Facility:
Name:
Fakultni Nemocnice Brno
Address:
City:
Brno
Zip:
62500
Country:
Czechia
Facility:
Name:
Masaryk Memorial Cancer Institute
Address:
City:
Brno
Zip:
656 53
Country:
Czechia
Facility:
Name:
University Hospital Olomouc
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Facility:
Name:
Multiscan s.r.o
Address:
City:
Pardubice
Zip:
532 01
Country:
Czechia
Facility:
Name:
Fakultni nemocnice v Motole
Address:
City:
Prague 4
Zip:
14059
Country:
Czechia
Facility:
Name:
Charles General University Hospital, Prague
Address:
City:
Prague
Zip:
12808
Country:
Czechia
Facility:
Name:
Krajska nemocnice Tomase Bati Zlin
Address:
City:
Zlin
Zip:
760 01
Country:
Czechia
Facility:
Name:
CHU Jean Minjoz
Address:
City:
Besancon
Zip:
25030
Country:
France
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Facility:
Name:
Centre Georges François Leclerc
Address:
City:
Dijon
Zip:
21000
Country:
France
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Zip:
59000
Country:
France
Facility:
Name:
Clinique Francois Chenieux
Address:
City:
Limoges
Zip:
87039
Country:
France
Facility:
Name:
Ico René Gauducheau
Address:
City:
Loire Atlantique
Zip:
44 805
Country:
France
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69373
Country:
France
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Zip:
13009
Country:
France
Facility:
Name:
Institut Regional du Cancer de Montpellier
Address:
City:
Montpellier Cedex 5
Zip:
34298
Country:
France
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75248
Country:
France
Facility:
Name:
Centre Hospitalier Lyon-Sud
Address:
City:
Pierre-benite
Zip:
69310
Country:
France
Facility:
Name:
Hopital Privé des Cotes d'Armor
Address:
City:
Plerin
Zip:
22190
Country:
France
Facility:
Name:
Centre Jean Bernard Service d'Oncologie Médicale
Address:
City:
Rennes Cedex
Zip:
35042
Country:
France
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Country:
France
Facility:
Name:
Institut Universitaire du Cancer de Toulouse Oncopole
Address:
City:
Toulouse Cedex 9
Zip:
31059
Country:
France
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Facility:
Name:
Universitaetsklinikum Freiburg, Klinik fuer Frauenheilkunde
Address:
City:
Baden-Württemberg
Zip:
79106
Country:
Germany
Facility:
Name:
University Hospital rechts der Isar Technical University of Munich
Address:
City:
Bayern
Zip:
81675
Country:
Germany
Facility:
Name:
Vivantes Klinikum am Urban
Address:
City:
Berlin
Zip:
10967
Country:
Germany
Facility:
Name:
HELIOS Klinikum Berlin-Buch
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Facility:
Name:
Marienhospital Bottrop
Address:
City:
Bottrop
Zip:
46236
Country:
Germany
Facility:
Name:
Universitätsklinik Erlangen
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Facility:
Name:
SRH Wald-Klinikum Gera GmbH
Address:
City:
Gera
Zip:
07548
Country:
Germany
Facility:
Name:
Universitatsklinikum Hamburg-Eppendorf
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Facility:
Name:
Medizinische Hochschule Hannover
Address:
City:
Hannover
Zip:
D-30625
Country:
Germany
Facility:
Name:
Nationales Centrum für Tumorerkrankungen Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Facility:
Name:
Universitätsklinikum Mannheim
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Facility:
Name:
Universitatsklinikum Munster
Address:
City:
Munster
Zip:
48149
Country:
Germany
Facility:
Name:
LMU Klinikum der Universitat München
Address:
City:
München
Zip:
81377
Country:
Germany
Facility:
Name:
Universitäts - Frauenklinik
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Facility:
Name:
Alexandra General Hospital
Address:
City:
Athens
Zip:
11528
Country:
Greece
Facility:
Name:
Attikon Hospital
Address:
City:
Athens
Zip:
124 62
Country:
Greece
Facility:
Name:
University Hospital of Heraklion
Address:
City:
Heraklion
Country:
Greece
Facility:
Name:
University Hospital of Larissa
Address:
City:
Larissa
Zip:
41110
Country:
Greece
Facility:
Name:
University Hospital of Patras
Address:
City:
Patras
Zip:
26 500
Country:
Greece
Facility:
Name:
Bioclinic of Thessaloniki
Address:
City:
Thessaloniki
Zip:
546 22
Country:
Greece
Facility:
Name:
Euromedica General Clinic of Thessaloniki
Address:
City:
Thessaloniki
Zip:
546 45
Country:
Greece
Facility:
Name:
Hong Kong Integrated Oncology Centre
Address:
City:
Hong Kong
Zip:
0
Country:
Hong Kong
Facility:
Name:
Prince of Wales Hospital
Address:
City:
New Territories
Country:
Hong Kong
Facility:
Name:
Queen Mary Hospital
Address:
City:
Pok Fu Lam
Zip:
0
Country:
Hong Kong
Facility:
Name:
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Address:
City:
Budapest
Zip:
1083
Country:
Hungary
Facility:
Name:
Debreceni Egyetem Klinikai Központ
Address:
City:
Debrecen
Zip:
4032
Country:
Hungary
Facility:
Name:
Bács-Kiskun Varmegyei Oktatokorhaz, Onkaradiologiai Kozpont
Address:
City:
Kecskemét
Zip:
6000
Country:
Hungary
Facility:
Name:
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Onkoradiologia
Address:
City:
Nyiregyhaza
Zip:
4400
Country:
Hungary
Facility:
Name:
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Address:
City:
Szeged
Zip:
6720
Country:
Hungary
Facility:
Name:
Oncology Institute Rambam Health Care Campus
Address:
City:
Haifa
Zip:
31096
Country:
Israel
Facility:
Name:
Shaare Zedek Medical Center
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Facility:
Name:
Hadassah Medical Center
Address:
City:
Jerusalem
Country:
Israel
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Facility:
Name:
Sheba Medical Center
Address:
City:
Ramat Gan
Zip:
52621
Country:
Israel
Facility:
Name:
Tel Aviv Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
64239
Country:
Israel
Facility:
Name:
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Address:
City:
Ancona AN
Zip:
60126
Country:
Italy
Facility:
Name:
Centro di Riferimento Oncologico - IRCCS
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Facility:
Name:
Humanitas Gavazzeni
Address:
City:
Bergamo
Zip:
24125
Country:
Italy
Facility:
Name:
ASST Papa Giovanni XXIII
Address:
City:
Bergamo
Zip:
24127
Country:
Italy
Facility:
Name:
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
Address:
City:
Bologna
Country:
Italy
Facility:
Name:
Humanitas Istituto Clinico Catanese
Address:
City:
Catania
Zip:
95045
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Mater Domini
Address:
City:
Catanzaro
Zip:
88100
Country:
Italy
Facility:
Name:
IRCCS Ospedale Policlinico San Martino
Address:
City:
Genova GE
Zip:
16132
Country:
Italy
Facility:
Name:
Fondazione IRCCS San Raffaele del Monte Tabor
Address:
City:
Milano
Zip:
20132
Country:
Italy
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milan
Zip:
20141
Country:
Italy
Facility:
Name:
Azienda Ospedaliera San Gerardo
Address:
City:
Monza
Zip:
20090
Country:
Italy
Facility:
Name:
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Istituto Oncologico Veneto IOV
Address:
City:
Padova
Zip:
35128
Country:
Italy
Facility:
Name:
Irccs Crob
Address:
City:
Rionero in Vulture
Zip:
85028
Country:
Italy
Facility:
Name:
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Address:
City:
Roma
Zip:
161
Country:
Italy
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Roma
Zip:
168
Country:
Italy
Facility:
Name:
Istituto Clinico Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Facility:
Name:
Aichi Cancer Center Hospital
Address:
City:
Aichi
Zip:
464-8681
Country:
Japan
Facility:
Name:
Tohoku University Hospital
Address:
City:
Aoba-ku
Zip:
980-8574
Country:
Japan
Facility:
Name:
Juntendo University Hospital
Address:
City:
Bunkyo-ku
Zip:
113-8431
Country:
Japan
Facility:
Name:
Chiba Cancer Center
Address:
City:
Chiba
Zip:
260-8717
Country:
Japan
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
1040045
Country:
Japan
Facility:
Name:
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Address:
City:
Chuo-ku
Zip:
541-8567
Country:
Japan
Facility:
Name:
National Hospital Organization Shikoku Cancer Center
Address:
City:
Ehime
Zip:
791-0280
Country:
Japan
Facility:
Name:
Fukushima Medical University Hospital
Address:
City:
Fukushima
Country:
Japan
Facility:
Name:
Social Medical Corporation Hakuaikai Sagara Hospital
Address:
City:
Kagoshima-shi
Zip:
892-0833
Country:
Japan
Facility:
Name:
Tokai University Hospital
Address:
City:
Kanagawa
Zip:
259-1193
Country:
Japan
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Facility:
Name:
Saitama Cancer Center
Address:
City:
Kitaadachi-gun
Zip:
362-0806
Country:
Japan
Facility:
Name:
Cancer Institute Hospital of JFCR
Address:
City:
Koto-Ku
Zip:
135-8550
Country:
Japan
Facility:
Name:
Kumamoto University Hospital
Address:
City:
Kumamoto- shi
Zip:
860-8556
Country:
Japan
Facility:
Name:
Kyoto University Hospital
Address:
City:
Kyoto-shi
Zip:
606-8507
Country:
Japan
Facility:
Name:
National Hospital Organization Kyushu Cancer Center
Address:
City:
Minami-ku
Zip:
811-1395
Country:
Japan
Facility:
Name:
Nagoya University Hospital
Address:
City:
Nagoya
Zip:
466-8560
Country:
Japan
Facility:
Name:
Hiroshima City Hiroshima Citizens Hospital
Address:
City:
Naka-ku
Zip:
730-8518
Country:
Japan
Facility:
Name:
Hyogo Medical University Hospital
Address:
City:
Nishinomiya-shi
Zip:
663-8501
Country:
Japan
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama
Zip:
700-8558
Country:
Japan
Facility:
Name:
Gunma Prefectural Cancer Center
Address:
City:
Ota
Zip:
373-8550
Country:
Japan
Facility:
Name:
National Hospital Organization Hokkaido Cancer Center
Address:
City:
Sapporo
Zip:
003-0804
Country:
Japan
Facility:
Name:
Center Hospital of the National Center for Global Health and Medicine
Address:
City:
Shinjuku-ku
Zip:
162-8655
Country:
Japan
Facility:
Name:
Showa University Hospital
Address:
City:
Tokyo
Zip:
142-8555
Country:
Japan
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Yokohama
Zip:
241-8515
Country:
Japan
Facility:
Name:
Samsung Medical Center
Address:
City:
Gangnam-Gu
Zip:
06351
Country:
Korea, Republic of
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si Gyeonggi-do
Zip:
10408
Country:
Korea, Republic of
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Gyeongsangbuk-do
Zip:
41404
Country:
Korea, Republic of
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam
Zip:
13620
Country:
Korea, Republic of
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Facility:
Name:
Hospital Kuala Lumpur
Address:
City:
Kuala Lumpur
Zip:
50586
Country:
Malaysia
Facility:
Name:
University Malaya Medical Centre
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Facility:
Name:
Sarawak General Hospital
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Facility:
Name:
Institut Kanser Negara
Address:
City:
Putrajaya
Zip:
62250
Country:
Malaysia
Facility:
Name:
Centro de Investigacion y Avances Medicos Especializados
Address:
City:
Cancún
Zip:
77550
Country:
Mexico
Facility:
Name:
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Address:
City:
Mexico City
Zip:
04700
Country:
Mexico
Facility:
Name:
Hospital Universitario Dr. José Eleuterio González
Address:
City:
Monterrey
Zip:
64460
Country:
Mexico
Facility:
Name:
FUCAM
Address:
City:
México
Zip:
4980
Country:
Mexico
Facility:
Name:
Clinica Integral Internacional de Oncologia S de RL de CV
Address:
City:
Puebla
Zip:
72530
Country:
Mexico
Facility:
Name:
Centro Medico Zambrano Hellion
Address:
City:
San Pedro Garza García
Zip:
64710
Country:
Mexico
Facility:
Name:
Centro de Atención e Investigación Clínica en Oncología
Address:
City:
Yucatán
Zip:
97134
Country:
Mexico
Facility:
Name:
Copemicus Podmiot Leczniczy Wojewodzkie Centrum Okologii w Gdansku
Address:
City:
Gdansk
Zip:
80-219
Country:
Poland
Facility:
Name:
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o
Address:
City:
Krakow
Zip:
31-826
Country:
Poland
Facility:
Name:
Instytut MSF Sp. z o.o.
Address:
City:
Lodz
Zip:
90-302
Country:
Poland
Facility:
Name:
Wojewodzki Szpital Specjalistyczny lm. Stefana Kardynala Wyszynsklego SPZOZ w Lublinie
Address:
City:
Lublin
Zip:
19713
Country:
Poland
Facility:
Name:
LUX MED Onkologia Sp. Zo.o.
Address:
City:
Warszawa
Zip:
01-748
Country:
Poland
Facility:
Name:
Maria Sklodowska - Curie Institute of Oncology
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Facility:
Name:
Centro Clinico Academico - Hospital de Braga
Address:
City:
Braga
Country:
Portugal
Facility:
Name:
Hospital da Senhora da Oliveira Guimaraes
Address:
City:
Guimarães
Zip:
4835-044
Country:
Portugal
Facility:
Name:
Centro Hospitalar de Lisboa Central, E.P.E . - Hospital de Santo Antonio dos Capuchos
Address:
City:
Lisbon
Zip:
1153-302
Country:
Portugal
Facility:
Name:
Fundacao Champalimaud
Address:
City:
Lisbon
Zip:
1400-038
Country:
Portugal
Facility:
Name:
Centro Hospitalar Lisboa Norte, EPE
Address:
City:
Lisbon
Zip:
1649-035
Country:
Portugal
Facility:
Name:
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano
Address:
City:
Matosinhos
Zip:
4464-513
Country:
Portugal
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119228
Country:
Singapore
Facility:
Name:
National Cancer Centre Singapore
Address:
City:
Singapore
Zip:
169610
Country:
Singapore
Facility:
Name:
Tan Tock Seng Hospital
Address:
City:
Singapore
Zip:
308433
Country:
Singapore
Facility:
Name:
Wilgers Oncology Centre
Address:
City:
Gauteng
Zip:
0081
Country:
South Africa
Facility:
Name:
Wits Clinical Research
Address:
City:
Johannesburg
Zip:
2192
Country:
South Africa
Facility:
Name:
The Medical Oncology Centre of Rosebank
Address:
City:
Johannesburg
Zip:
2196
Country:
South Africa
Facility:
Name:
Cape Town Oncology Trials
Address:
City:
Kraaifontein
Zip:
7570
Country:
South Africa
Facility:
Name:
Hospital Universitari Dexeus
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Facility:
Name:
Hospital Universitari Vall D'Hebron
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Facility:
Name:
Hospital de Basurto
Address:
City:
Bilbo
Zip:
48013
Country:
Spain
Facility:
Name:
Hospital Universitario Reina Sofia
Address:
City:
Córdoba
Zip:
14004
Country:
Spain
Facility:
Name:
Hospital General Universitario De Elche
Address:
City:
Elche
Zip:
3203
Country:
Spain
Facility:
Name:
Hospital Universitario de Jaen
Address:
City:
Jaen
Zip:
23007
Country:
Spain
Facility:
Name:
Hospital Beata María Ana
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Facility:
Name:
Hospital General Universitario Gregorio Marañón
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Facility:
Name:
Hospital Universitario Ramón y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Facility:
Name:
Hospital Clinico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Hospital Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37002
Country:
Spain
Facility:
Name:
Hospital Clínico Universitario de Santiago de Compostela - CHUS
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Zip:
41071
Country:
Spain
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Seville
Zip:
41013
Country:
Spain
Facility:
Name:
Instituto Valenciano De Oncologia (IVO)
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Facility:
Name:
Hospital Clínico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Facility:
Name:
Kaohsiung Chang Gung Memorial Hospital
Address:
City:
Kaohsiung City
Zip:
83301
Country:
Taiwan
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
807
Country:
Taiwan
Facility:
Name:
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
Address:
City:
New Taipei City
Zip:
235
Country:
Taiwan
Facility:
Name:
Chi Mei Hospital, Liouying
Address:
City:
Tainan City
Zip:
73657
Country:
Taiwan
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei City
Zip:
11217
Country:
Taiwan
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10048
Country:
Taiwan
Facility:
Name:
Tri-Service General Hospital
Address:
City:
Taipei
Zip:
11490
Country:
Taiwan
Facility:
Name:
Koo Foundation Sun Yat-Sen Cancer Center
Address:
City:
Taipei
Zip:
999999
Country:
Taiwan
Facility:
Name:
Chang Gung Memorial Hospital, Linkou
Address:
City:
Taoyuan City
Zip:
33305
Country:
Taiwan
Facility:
Name:
Barts Cancer Institute
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Facility:
Name:
University College London Hospitals
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Zip:
SW10 9NH
Country:
United Kingdom
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Facility:
Name:
Nottingham University Hospitals NHS Trust
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Start date:
May 8, 2023
Completion date:
December 2028
Lead sponsor:
Agency:
Gilead Sciences
Agency class:
Industry
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05840211
https://www.gileadclinicaltrials.com/study?nctid=NCT05840211