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JOURNAL ONKOLOGIE – STUDIE

A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

Rekrutierend

NCT-Nummer:
NCT04546009

Studienbeginn:
Oktober 2020

Letztes Update:
21.07.2021

Wirkstoff:
Letrozole, Letrozole-matched Placebo, Palbociclib, LHRH Agonist, Giredestrant, Giredestrant-matched Placebo

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: BO41843 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. Only)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 279)

Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
13581 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Städtisches Klinikum Brandenburg GmbH; Klinik für Gynäkologie und Geburtshilfe
14770 Brandenburg an der Havel
(Brandenburg)
GermanyRekrutierend» Google-Maps
Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik
09116 Chemnitz
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
01307 Dresden
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
45122 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
73730 Esslingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
49124 Georgsmarienhütte
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Dres.Andreas Ammon und Dirk Meyer
37073 Göttingen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Facharztzentrum Eppendorf, Studien GbR
20249 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Diakovere Henriettenstift, Frauenklinik
30559 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
30625 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin
56068 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Dres. Andreas Köhler und Roswitha Fuchs
63225 Langen
(Hessen)
GermanyRekrutierend» Google-Maps
St. Elisabeth-Krankenhaus, Senologie/Brustzentrum
04277 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Onkologische Schwerpunktpraxis Lübeck
23562 Lübeck
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Klinikum Magdeburg gGmbH, Brustzentrum; Klinik für Frauenheilkunde und Geburtshilfe
39130 Magdeburg
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Mannheim; Frauenklinik
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
80337 München
(Bayern)
GermanyRekrutierend» Google-Maps
Gemeinschaftspraxis für Hämatologie und Onkologie
48153 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg
88212 Ravensburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
18059 Rostock
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
54290 Trier
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
53840 Troisdorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitätsklinik Tübingen; Frauenklinik
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe
35578 Wetzlar
(Hessen)
GermanyZurückgezogen» Google-Maps
Marien-Hospital Witten; Frauenklinik Brustzentrum
58452 Witten
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Kaiser Permanente - Oakland
94611 Oakland
United StatesRekrutierend» Google-Maps
Kaiser Permanente - Roseville
95661 Roseville
United StatesRekrutierend» Google-Maps
Kaiser Permanente - San Leandro Medical Center
94577 San Leandro
United StatesRekrutierend» Google-Maps
California Cancer Associates for Research & Excellence, Inc.
92069 San Marcos
United StatesRekrutierend» Google-Maps
Kaiser Permanente - South San Francisco
94080 South San Francisco
United StatesRekrutierend» Google-Maps
Stanford Univ Medical Center
94305 Stanford
United StatesRekrutierend» Google-Maps
Kaiser Permanente - Vallejo
94589 Vallejo
United StatesRekrutierend» Google-Maps
Kaiser Permanente - Walnut Creek
94596 Walnut Creek
United StatesRekrutierend» Google-Maps
University of Colorado
80045-2517 Aurora
United StatesRekrutierend» Google-Maps
Rocky Mountain Cancer Center
80218 Denver
United StatesRekrutierend» Google-Maps
University of Miami; Dept Sylvester Cancer Center
33442 Deerfield Beach
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists - Fort Myers (Broadway)
33901 Fort Myers
United StatesRekrutierend» Google-Maps
Memorial Regional Cancer Ctr
33021 Hollywood
United StatesRekrutierend» Google-Maps
SCRI Florida Cancer Specialists North; Research Office North Region.
33705 Saint Petersburg
United StatesRekrutierend» Google-Maps
SCRI Florida Cancer Specialists PAN
32308 Tallahassee
United StatesRekrutierend» Google-Maps
Northwest Georgia Oncology Centers PC - Marietta
30060 Marietta
United StatesRekrutierend» Google-Maps
Mercy Medical Center
21202 Baltimore
United StatesRekrutierend» Google-Maps
Maryland Oncology Hematology; Maryland Oncology Hematology, PA
20902 Silver Spring
United StatesRekrutierend» Google-Maps
Beth Israel Deaconess Medical Center
02215 Boston
United StatesRekrutierend» Google-Maps
US oncology research at Minnesota Oncology
55404 Minneapolis
United StatesRekrutierend» Google-Maps
HCA Midwest Division
64132 Kansas City
United StatesRekrutierend» Google-Maps
St. Vincent Frontier Cancer Center
59101 Billings
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center Basking Ridge
07920 Basking Ridge
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering - Monmouth
07748 Middletown
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center at Bergen
07645 Montvale
United StatesRekrutierend» Google-Maps
Jefferson Health New Jersey
08080 Sewell
United StatesRekrutierend» Google-Maps
Cooper Cancer Institute
08043 Voorhees
United StatesRekrutierend» Google-Maps
New Mexico Oncology Hematology Consultants
87109 Albuquerque
United StatesRekrutierend» Google-Maps
Presbyterian Kaseman Hospital
87110 Albuquerque
United StatesRekrutierend» Google-Maps
University of New Mexico Cancer Center
87131 Albuquerque
United StatesRekrutierend» Google-Maps
San Juan Oncology Associates
87401 Farmington
United StatesRekrutierend» Google-Maps
Memorial Medical Center
88011 Las Cruces
United StatesRekrutierend» Google-Maps
Presbyterian Rust Medical Center/Jorgensen Cancer Center
87124 Rio Rancho
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center at Westchester
10604 Harrison
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center at Nassau
11553 Uniondale
United StatesRekrutierend» Google-Maps
Waverly Hematology Oncology
27518 Cary
United StatesRekrutierend» Google-Maps
Fairview Hospital; Cleveland Clinic Cancer Center
44111 Cleveland
United StatesRekrutierend» Google-Maps
The Cleveland Clinic Foundation
44195 Cleveland
United StatesRekrutierend» Google-Maps
Hillcrest Hospital; Hirsch Cancer Center
44124 Mayfield Heights
United StatesRekrutierend» Google-Maps
Strongsville Hospital; Cleveland Clinic Cancer Center
44136 Strongsville
United StatesRekrutierend» Google-Maps
Providence Portland Medical Ctr
97225 Portland
United StatesRekrutierend» Google-Maps
Thomas Jefferson University Hospital
19107 Philadelphia
United StatesRekrutierend» Google-Maps
Asplundh Cancer Pavilion
19090 Willow Grove
United StatesRekrutierend» Google-Maps
Charleston Oncology, P .A
29414 Charleston
United StatesRekrutierend» Google-Maps
Sarah Cannon Research Inst.
37203 Nashville
United StatesAktiv, nicht rekrutierend» Google-Maps
Harrington Cancer Center
79106 Amarillo
United StatesRekrutierend» Google-Maps
Texas Oncology-Baylor Sammons Cancer Center
75246 Dallas
United StatesAktiv, nicht rekrutierend» Google-Maps
The Center for Cancer and Blood Disorders - Fort Worth
76104 Fort Worth
United StatesRekrutierend» Google-Maps
Baylor St. Luke's Medical Center
77030 Houston
United StatesRekrutierend» Google-Maps
Houston Methodist Hospital
77030 Houston
United StatesRekrutierend» Google-Maps
Inova Fairfax Hospital
22031 Fairfax
United StatesRekrutierend» Google-Maps
Virginia Oncology Associates
23502 Norfolk
United StatesAktiv, nicht rekrutierend» Google-Maps
Providence Regional Cancer Partnership
98201 Everett
United StatesRekrutierend» Google-Maps
Northwest Medical Specialties
98405 Tacoma
United StatesRekrutierend» Google-Maps
University of Wisconsin
53792 Madison
United StatesRekrutierend» Google-Maps
Hospital de Onc Angel Roffo
1425 Buenos Aires
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Fundación CENIT para la Investigación en Neurociencias
C1125ABD Buenos Aires
ArgentinaRekrutierend» Google-Maps
Hospital Britanico
C1280AEB Ciudad Autonoma Bs As
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Instituto de Investigaciones Metabolicas (Idim)
C1012AAR Ciudad Autonoma de Buenos Aires
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Hospital Provincial del Centenario
2000 Rosario
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Instituto de Oncología de Rosario
S2000KZE Rosario
ArgentinaAktiv, nicht rekrutierend» Google-Maps
CEMER Centro Medico de Enfermedades Respiratorias
B1602DQD Vicente López
ArgentinaRekrutierend» Google-Maps
Kinghorn Cancer Centre; St Vincents Hospital
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps
Calvary Mater Newcastle; Medical Oncology
2298 Waratah
AustraliaAktiv, nicht rekrutierend» Google-Maps
Mater Hospital Brisbane
4101 South Brisbane
AustraliaRekrutierend» Google-Maps
Princess Alexandra Hospital; Division of Cancer Services
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Flinders Medical Centre; Medical Oncology
5042 Bedford Park
AustraliaRekrutierend» Google-Maps
Austin Health; Cancer Clinical Trial Centre
3084 Heidelberg
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Centre-East Melbourne
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Fiona Stanley Hospital - Medical Oncology
6150 Murdoch
AustraliaRekrutierend» Google-Maps
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
5020 Salzburg
AustriaRekrutierend» Google-Maps
A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
4400 Steyr
AustriaRekrutierend» Google-Maps
Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie
2700 Wiener Neustadt
AustriaRekrutierend» Google-Maps
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
1090 Wien
AustriaRekrutierend» Google-Maps
Cliniques Universitaires St-Luc
1200 Bruxelles
BelgiumRekrutierend» Google-Maps
Jessa Zkh (Campus Virga Jesse)
3500 Hasselt
BelgiumRekrutierend» Google-Maps
Hospital Sao Rafael - HSR
41253-190 Salvador
BrazilRekrutierend» Google-Maps
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
74605-070 Goiania
BrazilRekrutierend» Google-Maps
Hospital do Cancer de Pernambuco - HCP
50040-000 Recife
BrazilRekrutierend» Google-Maps
Santa Casa de Misericordia de Porto Alegre
90050-170 Porto Alegre
BrazilRekrutierend» Google-Maps
Hospital Sao Lucas - PUCRS
90610-000 Porto Alegre
BrazilRekrutierend» Google-Maps
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
01317-001 Sao Paulo
BrazilRekrutierend» Google-Maps
Royal Victoria Regional Health Centre
L4M 6M2 Barrie
CanadaRekrutierend» Google-Maps
William Osler Health System Brampton Civic Hospital
L6R 3J7 Brampton
CanadaRekrutierend» Google-Maps
Ottawa Hospital Research Institute
K1Y 4E9 Ottawa
CanadaRekrutierend» Google-Maps
Princess Margaret Cancer Center
M5G 1Z5 Toronto
CanadaRekrutierend» Google-Maps
Universite de Montreal - Hopital Maisonneuve-Rosemont
H1T 2M4 Montreal
CanadaAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier de l'Université de Montréal (CHUM)
H2X 0C2 Montreal
CanadaRekrutierend» Google-Maps
McGill University Health Center
H4A 3J1 Montreal
CanadaAktiv, nicht rekrutierend» Google-Maps
Hopital du Saint Sacrement
G1S 4L8 Quebec City
CanadaRekrutierend» Google-Maps
Centre Hospitalier Regional De Rimouski
G5L 5T1 Rimouski
CanadaRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
J1H 5N4 Sherbrooke
CanadaRekrutierend» Google-Maps
Herlev Hospital; Afdeling for Kræftbehandling
2730 Herlev
DenmarkRekrutierend» Google-Maps
Sjællands Universitetshospital, Næstved; Onkologisk Afdeling
4700 Naestved
DenmarkRekrutierend» Google-Maps
Odense Universitetshospital, Onkologisk Afdeling R
5000 Odense C
DenmarkRekrutierend» Google-Maps
Vejle Sygehus; Onkologisk Afdeling
7100 Vejle
DenmarkRekrutierend» Google-Maps
ICO Paul Papin; Oncologie Medicale.
49055 Angers
FranceRekrutierend» Google-Maps
Centre Hospitalier de La Cote Basque; Oncologie
64109 Bayonne
FranceRekrutierend» Google-Maps
CHD DE VENDEE; Unité de Recherche Clinique Onco-Hematologie
85925 La Roche Sur Yon
FranceRekrutierend» Google-Maps
Institut régional du Cancer Montpellier
34298 Montpellier
FranceRekrutierend» Google-Maps
Chu La Miletrie; Oncologie Medicale
86021 Poitiers
FranceRekrutierend» Google-Maps
Institut Jean Godinot; Oncologie Medicale
51056 Reims CEDEX
FranceRekrutierend» Google-Maps
Centre Eugene Marquis; Service d'oncologie
35042 Rennes
FranceRekrutierend» Google-Maps
Centre Alexis Vautrin; Oncologie Medicale
54519 Vandoeuvre-les-nancy
FranceRekrutierend» Google-Maps
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
115 22 Athens
GreeceRekrutierend» Google-Maps
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
115 22 Athens
GreeceRekrutierend» Google-Maps
University Hospital of Larissa;Department of Medical Oncology
411 10 Larissa
GreeceRekrutierend» Google-Maps
Euromedical General Clinic of Thessaloniki; Oncology Department
546450 Thessaloniki
GreeceRekrutierend» Google-Maps
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
Hong Kong
Hong KongRekrutierend» Google-Maps
Princess Margaret Hospital; Oncology
Hong Kong
Hong KongRekrutierend» Google-Maps
Queen Mary Hospital; Dept of Medicine
Hong Kong
Hong KongAktiv, nicht rekrutierend» Google-Maps
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
7623 Pécs
HungaryRekrutierend» Google-Maps
Davidof Center - Rabin Medical Center
49100 Petah Tiqwa
IsraelRekrutierend» Google-Maps
Chaim Sheba Medical Center; Oncology Dept
5262100 Ramat Gan
IsraelRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Ctr; Oncology
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
80131 Napoli
ItalyRekrutierend» Google-Maps
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
47014 Meldola
ItalyRekrutierend» Google-Maps
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
00144 Roma
ItalyRekrutierend» Google-Maps
A.O. Universitaria S. Martino Di Genova
16132 Genova
ItalyRekrutierend» Google-Maps
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
25123 Brescia
ItalyAktiv, nicht rekrutierend» Google-Maps
Istituto Europeo Di Oncologia
20141 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
Fondazione del Piemonte per l'Oncologia (IRCCS)
10060 Candiolo
ItalyRekrutierend» Google-Maps
Ospedale Sacro Cuore Don Calabria
37024 Negrar
ItalyRekrutierend» Google-Maps
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
35128 Padova
ItalyRekrutierend» Google-Maps
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
36100 Vicenza
ItalyAktiv, nicht rekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Chiba
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka
JapanAktiv, nicht rekrutierend» Google-Maps
Fukushima Medical University Hospital
960-1295 Fukushima
JapanRekrutierend» Google-Maps
Hiroshima City Hiroshima Citizens Hospital
730-8518 Hiroshima
JapanAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization Hokkaido Cancer Center
003-0804 Hokkaido
JapanRekrutierend» Google-Maps
Kumamoto University Hospital
860-8556 Kumamoto
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanRekrutierend» Google-Maps
National Hospital Organization Osaka National Hospital
540-0006 Osaka
JapanRekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Tokyo
JapanRekrutierend» Google-Maps
St. Luke's Internat. Hospital, Breast Surgical Oncology
104-8560 Tokyo
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
Chungbuk National University Hospital
28644 Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
Kyungpook National University Medical Center
41404 Daegu
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Ajou University Medical Center
16499 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Korea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Gangnam Severance Hospital
06273 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06531 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul St Mary's Hospital
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ewha Womans University Mokdong Hospital
07985 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Korea University Guro Hospital
08308 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Ulsan University Hosiptal
44033 Ulsan
Korea, Republic ofRekrutierend» Google-Maps
Health Pharma Professional Research
03100 Cdmx
MexicoRekrutierend» Google-Maps
Christus Muguerza Clinica Vidriera
64570 Monterrey
MexicoRekrutierend» Google-Maps
Auckland City Hospital; Clinical Oncology
1023 Auckland
New ZealandRekrutierend» Google-Maps
Waikato Breast Cancer Trust
3240 Hamilton
New ZealandRekrutierend» Google-Maps
Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
15088 Lima
PeruRekrutierend» Google-Maps
Instituto Nacional de Enfermedades Neoplasicas
Lima 34 Lima
PeruRekrutierend» Google-Maps
Instituto Regional de Enfermedades Neoplasicas - IREN Norte
13014 Trujillo
PeruRekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
80-214 Gdańsk
PolandRekrutierend» Google-Maps
Szpital Morski im. PCK; Poradnia Onkologiczna
81-519 Gdynia
PolandRekrutierend» Google-Maps
Woj. Wielospecjalistyczne Centrum Onkol. i Traumat. im.M.Kopernika; Woj. Przychodnia Onkologiczna
93-513 Lodz
PolandRekrutierend» Google-Maps
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
02-781 Warszawa
PolandRekrutierend» Google-Maps
Hospital da Luz; Departamento de Oncologia Medica
1500-650 Lisboa
PortugalRekrutierend» Google-Maps
IPO do Porto; Servico de Oncologia Medica
4200-072 Porto
PortugalAktiv, nicht rekrutierend» Google-Maps
Respublikanskiy Onkologicheskiy Dispanser
430032 Saransk
Russian FederationAktiv, nicht rekrutierend» Google-Maps
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
111123 Moskva
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Ryazan Regional clinical oncology dispensary
390011 Ryazan
Russian FederationRekrutierend» Google-Maps
Chelyabinsk region oncology dispensary
454087 Chelyabinsk
Russian FederationRekrutierend» Google-Maps
Podolsk City Clinical Hospital; Hematology
142100 Podolsk
Russian FederationAktiv, nicht rekrutierend» Google-Maps
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
197758 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Multidisciplinary clinic Reaviz
443011 Samara
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Regional Clinical Oncology Hospital
150040 Yaroslavl
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404 Taichung
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100 Taipei
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104 Taipei
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Chang Gung Memorial Hosipital at Linkou
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10330 Bangkok
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Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology
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Songklanagarind Hospital; Department of Oncology
90110 Songkhla
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Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
22030 Edirne
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34214 Istanbul
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Katip Celebi University Ataturk Training and Research Hospital; Oncology
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Kocaeli University Faculty of Medicine; Medical oncology
31380 Izmit
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Medeniyet University Goztepe Training and Research Hospital.
34722 Kadiköy
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Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
44280 Malatya
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06230 Sihhiye/Ankara
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Municipal Institution City Clinical Hospital #4 of Dnipro City Council
49102 Dnipropetrovsk
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SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU
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Ivano-Frankivsk Regional Oncology Center
76018 Ivano-Frankivsk
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ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department
50048 Kryvyi Rih
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40005 Sumy
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Royal Sussex County Hospital
BN2 5BE Brighton
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Velindre Cancer Centre; Clinical Trials Unit
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LE1 5WW Leicester
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SW3 6JJ London
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ME16 9QQ Maidstone
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ST4 6QG Stoke-on-Trent
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SM2 5PT Sutton
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TR1 3LQ Truro
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Alle anzeigen

Studien-Informationen

Brief Summary:

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate

the efficacy and safety of giredestrant combined with palbociclib compared with letrozole

combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal

growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or

metastatic breast cancer.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- For women who are premenopausal or perimenopausal and for men: treatment with approved

LHRH agonist therapy for the duration of study treatment

- Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast,

not amenable to treatment with curative intent

- Documented ER-positive tumor and HER2-negative tumor, assessed locally

- Patients who have bilateral breast cancers which are both ER-positive and

HER2-negative can be included in the study because the metastases are suitably

targeted by the study treatments. If patients have bilateral tumors which are of

different biomarker status, then proof of the ER and HER2 status of the metastases is

required for study entry

- No history of systemic anti-cancer therapy for locally advanced (recurrent or

progressed) or metastatic disease

- Disease recurrence from early-stage breast cancer after standard adjuvant endocrine

therapy meeting the protocol-defined criteria of having received at least 24 months of

treatment without disease progression during treatment and a disease-free interval

since the completion of treatment that was greater than 12 months

- Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at

least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed

- Eastern Cooperative Oncology Group Performance Status 0-1

- Adequate organ function

Exclusion Criteria:

- Disease recurrence during or within 12 months of completing prior neoadjuvant or

adjuvant treatment with an aromatase inhibitor (AI)

- Disease recurrence during or within 12 months of completing prior neoadjuvant or

adjuvant treatment with any CDK4/6 inhibitor

- Prior treatment with a selective estrogen receptor degrader (SERD)

- Prior treatment with tamoxifen is permitted, provided the patient did not experience

disease recurrence within the first 24 months of treatment with tamoxifen

- Treatment with any investigational therapy within 28 days prior to study treatment

- Advanced, symptomatic, visceral spread that is at risk of life-threatening

complications

- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or

leptomeningeal disease

- Active cardiac disease or history of cardiac dysfunction

- Pregnant or breastfeeding

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 (Time Frame - From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months))



Secondary outcome:

1. Overall Survival (Time Frame - From randomization to death from any cause (up to 78 months))

2. Objective Response Rate, as Determined by the Investigator According to RECIST v1.1 (Time Frame - From randomization until disease progression or death (up to 78 months)):
The objective response rate is defined as the percentage of participants with a complete response or partial response on two consecutive occasions at least (≥)4 weeks apart.

3. Duration of Response, as Determined by the Investigator According to RECIST v1.1 (Time Frame - From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months))

4. Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1 (Time Frame - From randomization until disease progression or death (up to 78 months)):
The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response or partial response.

5. Time to Deterioration in Pain Level, Defined as the Time to First Documented ≥2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire (Time Frame - From Baseline until treatment discontinuation (up to 78 months))

6. Time to Deterioration in Pain Presence and Interference, Defined as the Time to First Documented ≥10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score (Time Frame - From Baseline until treatment discontinuation (up to 78 months)):
EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire

7. Time to Deterioration in Physical Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score (Time Frame - From Baseline until treatment discontinuation (up to 78 months))

8. Time to Deterioration in Role Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score (Time Frame - From Baseline until treatment discontinuation (up to 78 months))

9. Time to Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score (Time Frame - From Baseline until treatment discontinuation (up to 78 months))

10. Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) (Time Frame - From treatment initiation until 30 days after the final dose of study treatment (up to 78 months))

11. Number of Participants with Vital Sign Abnormalities Over the Course of the Study (Time Frame - Baseline, Days 1 and 15 of Cycles 1 and 2, and Day 1 of each cycle thereafter until treatment discontinuation (1 cycle is 28 days)):
Vital signs include respiratory rate, pulse rate, and systolic and diastolic blood pressure while the participant is in a seated position, and temperature.

12. Plasma Concentration of Giredestrant at Specified Timepoints (Time Frame - Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days))

13. Plasma Concentration of Palbociclib at Specified Timepoints (Time Frame - Days 1 and 15 of Cycle 1 (1 cycle is 28 days))

Studien-Arme

  • Experimental: Giredestrant + Letrozole-matched Placebo + Palbociclib
  • Active Comparator: Letrozole + Giredestrant-matched Placebo + Palbociclib

Geprüfte Regime

  • Giredestrant (GDC-9545 / RO7197597 / RG6171 / ):
    Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • Giredestrant-matched Placebo:
    Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • Letrozole:
    Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • Letrozole-matched Placebo:
    Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • Palbociclib:
    Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.
  • LHRH Agonist:
    Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Quelle: ClinicalTrials.gov


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