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JOURNAL ONKOLOGIE – STUDIE
VERITAC-2

A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.

Rekrutierend

NCT-Nummer:
NCT05654623

Studienbeginn:
März 2023

Letztes Update:
25.04.2024

Wirkstoff:
ARV-471, Fulvestrant

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Pfizer

Collaborator:
Arvinas Estrogen Receptor, Inc.

Studienleiter

Pfizer CT.gov Call Center
Study Director
Pfizer

Kontakt

Pfizer CT.gov Call Center
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 332)

Universitaetsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Gynäkologie Kompetenzzentrum Stralsund
18439 Stralsund
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Onkologische Schwerpunktpraxis Kurfuerstendamm
10707 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
CBCC Global Research, Inc.
93309 Bakersfield
United StatesRekrutierend» Google-Maps
Comprehensive Blood and Cancer Center
93309 Bakersfield
United StatesRekrutierend» Google-Maps
California Cancer Associates for Research and Excellence, Inc. (cCARE)
92024 Encinitas
United StatesRekrutierend» Google-Maps
California Cancer Associates for Research and Excellence
93720 Fresno
United StatesRekrutierend» Google-Maps
Providence Queen of the Valley Medical Center
94558 Napa
United StatesRekrutierend» Google-Maps
California Cancer Associates for Research and Excellence
92069 San Marcos
United StatesRekrutierend» Google-Maps
Providence Medical Foundation
95403 Santa Rosa
United StatesRekrutierend» Google-Maps
Olive View-UCLA Medical Center
91342 Sylmar
United StatesRekrutierend» Google-Maps
TMPN Cancer Care research office
90505 Torrance
United StatesRekrutierend» Google-Maps
Torrance Memorial Physician Network / Cancer Care
90505 Torrance
United StatesRekrutierend» Google-Maps
Smilow Cancer Hospital Care Center at Fairfield
06824 Fairfield
United StatesNoch nicht rekrutierend» Google-Maps
Smilow Cancer Hospital at Yale-New Haven
06510 New Haven
United StatesNoch nicht rekrutierend» Google-Maps
Yale-New Haven Hospital
06510 New Haven
United StatesNoch nicht rekrutierend» Google-Maps
Smilow Cancer Hospital Care Center at North Haven
06473 North Haven
United StatesNoch nicht rekrutierend» Google-Maps
Smilow Cancer Hospital Care Center at Trumbull
06611 Trumbull
United StatesNoch nicht rekrutierend» Google-Maps
Florida cancer specialists
32701 Altamonte Springs
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists BON
34135 Bonita Springs
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists BCC
34205 Bradenton
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists LRS
34211 Bradenton
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33511 Brandon
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists NFM
33909 Cape Coral
United StatesRekrutierend» Google-Maps
Morton Plant Hospital - BayCare Health System
33756 Clearwater
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33761 Clearwater
United StatesRekrutierend» Google-Maps
3T Radiology LLC
33073 Coconut Creek
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
32117 Daytona Beach
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
32003 Fleming Island
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists - South
33901 Fort Myers
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists COL
33905 Fort Myers
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists GLO
33908 Fort Myers
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
32605 Gainesville
United StatesRekrutierend» Google-Maps
Lakeland Regional Cancer Center
33805 Lakeland
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33770 Largo
United StatesRekrutierend» Google-Maps
Broward P.E.T. Imaging Center
33313 Lauderdale Lakes
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
34461 Lecanto
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists NGD
34102 Naples
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists NPW
34102 Naples
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
34474 Ocala
United StatesRekrutierend» Google-Maps
Florida Cancer specialists
32763 Orange City
United StatesRekrutierend» Google-Maps
Mid Florida Hematology and Oncology Center
32763 Orange City
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
32806 Orlando
United StatesRekrutierend» Google-Maps
POM MRI & Radiology Centers
33313 Plantation
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists PCH
33980 Port Charlotte
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33705 Saint Petersburg
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists SAC
34232 Sarasota
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists SAD
34236 Sarasota
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
34994 Stuart
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
32308 Tallahassee
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33607 Tampa
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
32159 The Villages
United StatesRekrutierend» Google-Maps
Florida Cancer Specialist
34655 Trinity
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists VIS
34285 Venice
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists VHP
34292 Venice
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
32960 Vero Beach
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33414 Wellington
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
33401 West Palm Beach
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
32789 Winter Park
United StatesRekrutierend» Google-Maps
Norton Cancer Institute - Downtown
40202 Louisville
United StatesRekrutierend» Google-Maps
Norton Cancer Institute, Downtown
40202 Louisville
United StatesRekrutierend» Google-Maps
Norton Cancer Institute, St Matthews Campus
40207 Louisville
United StatesRekrutierend» Google-Maps
Norton Women's & Children's Hospital
40207 Louisville
United StatesRekrutierend» Google-Maps
Norton Brownsboro Hospital
40241 Louisville
United StatesRekrutierend» Google-Maps
Norton Cancer Institute, Brownsboro Hospital Campus
40241 Louisville
United StatesRekrutierend» Google-Maps
University Medical Center New Orleans
70112 New Orleans
United StatesRekrutierend» Google-Maps
Louisiana State University Health Sciences Shreveport
71103 Shreveport
United StatesRekrutierend» Google-Maps
Hattiesburg Clinic Hematology/Oncology
39401 Hattiesburg
United StatesRekrutierend» Google-Maps
Mercy Clinic Oncology and Hematology
63011 Ballwin
United StatesRekrutierend» Google-Maps
Mercy Research - David C. Pratt Cancer Center
63141 Saint Louis
United StatesRekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada
89052 Henderson
United StatesRekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada
89074 Henderson
United StatesRekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada
89128 Las Vegas
United StatesRekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada
89144 Las Vegas
United StatesRekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada
89148 Las Vegas
United StatesRekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada
89169 Las Vegas
United StatesRekrutierend» Google-Maps
Dartmouth-Hitchcock Medical Center
03756 Lebanon
United StatesNoch nicht rekrutierend» Google-Maps
MSK Basking Ridge
07920 Basking Ridge
United StatesRekrutierend» Google-Maps
Astera Cancer Care
08816 East Brunswick
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering - Bergen
07645 Montvale
United StatesRekrutierend» Google-Maps
Hematology-Oncology Associates of Central New York, PC
13057 East Syracuse
United StatesRekrutierend» Google-Maps
MSKCC Investigational Drug Service Pharmacy
11101 Long Island City
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
MSK Evelyn H. Lauder Breast and Imaging Center
10065 New York
United StatesRekrutierend» Google-Maps
Hematology Oncology Associates of Rockland
10960 Nyack
United StatesRekrutierend» Google-Maps
Cancer Centers of Southwest Oklahoma
73505 Lawton
United StatesRekrutierend» Google-Maps
Cancer Centers of Southwest Oklahoma
73506 Lawton
United StatesRekrutierend» Google-Maps
Frank C Love Cancer Institute
73102 Oklahoma City
United StatesRekrutierend» Google-Maps
Hightower Clinical Trial Services
73102 Oklahoma City
United StatesRekrutierend» Google-Maps
SSM Health Medical Group - St Anthony
73102 Oklahoma City
United StatesRekrutierend» Google-Maps
Providence Cancer Institute Franz Clinic
97213 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Providence Portland Medical Center
97213 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Tennessee Oncology, PLLC
37055 Dickson
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37067 Franklin
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37066 Gallatin
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37075 Hendersonville
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37076 Hermitage
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37090 Lebanon
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37129 Murfreesboro
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37203 Nashville
United StatesRekrutierend» Google-Maps
Tennessee Oncology, PLLC
37203 Nashville
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37205 Nashville
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37207 Nashville
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37211 Nashville
United StatesRekrutierend» Google-Maps
Tennessee Oncology, PLLC
37160 Shelbyville
United StatesRekrutierend» Google-Maps
Tennessee Oncology PLLC
37167 Smyrna
United StatesRekrutierend» Google-Maps
Valley Cancer Associates
78550 Harlingen
United StatesRekrutierend» Google-Maps
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
75701 Tyler
United StatesRekrutierend» Google-Maps
Hematology Oncology Associates of Fredericksburg
22408 Fredericksburg
United StatesRekrutierend» Google-Maps
Bon Secours Memorial Regional Medical Center
23116 Mechanicsville
United StatesRekrutierend» Google-Maps
Bon Secours Cancer Institute at St. Francis
23114 Midlothian
United StatesNoch nicht rekrutierend» Google-Maps
Bon Secours St. Francis Medical Center
23114 Midlothian
United StatesRekrutierend» Google-Maps
Bon Secours St. Mary's Hospital
23226 Richmond
United StatesRekrutierend» Google-Maps
West Virginia University
26506 Morgantown
United StatesNoch nicht rekrutierend» Google-Maps
Fundación Cenit Para La Investigación En Neurociencias
1125 Caba
ArgentinaRekrutierend» Google-Maps
Centro Oncologico Korben
1426 Buenos Aires
ArgentinaRekrutierend» Google-Maps
Fundación Respirar
C1426ABP Buenos Aires
ArgentinaNoch nicht rekrutierend» Google-Maps
Sunshine Coast University Private Hospital
4575 Birtinya
AustraliaNoch nicht rekrutierend» Google-Maps
Sunshine Coast University Private Hospital
4575 Birtinya
AustraliaRekrutierend» Google-Maps
Cabrini Hospital -Brighton
3186 Brighton
AustraliaRekrutierend» Google-Maps
Antwerp University Hospital
2650 Edegem
BelgiumNoch nicht rekrutierend» Google-Maps
Cliniques universitaires Saint-Luc
1200 Woluwe-Saint-Lambert
BelgiumNoch nicht rekrutierend» Google-Maps
Grand Hôpital de Charleroi
6000 Charleroi
BelgiumNoch nicht rekrutierend» Google-Maps
Hospital Santa Rita de Cassia
29041-295 Vitoria
BrazilRekrutierend» Google-Maps
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
98700-000 Ijui
BrazilRekrutierend» Google-Maps
Hospital Moinhos de Vento
90035-001 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
90110-270 Porto Alegre
BrazilRekrutierend» Google-Maps
Centro de Pesquisa Clínica - Área Administrativa
90850-170 Porto Alegre
BrazilRekrutierend» Google-Maps
Hospital Mae de Deus
90880-480 Porto Alegre
BrazilRekrutierend» Google-Maps
Faculdade de Medicina do ABC
09060-650 Santo André
BrazilRekrutierend» Google-Maps
A. C. Camargo Cancer Center
01509-010 Sao Paulo
BrazilRekrutierend» Google-Maps
IBCC - Instituto Brasileiro de Controle do Câncer
03102002 São Paulo
BrazilRekrutierend» Google-Maps
IBCC - Núcleo de Pesquisa e Ensino
04014-002 São Paulo
BrazilRekrutierend» Google-Maps
Complex Oncology Center - Burgas
8000 Burgas
BulgariaRekrutierend» Google-Maps
Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD
5300 Gabrovo
BulgariaRekrutierend» Google-Maps
Specialized Hospital for Active Treatment of Oncology - Haskovo
6300 Haskovo
BulgariaRekrutierend» Google-Maps
Complex Oncology Center - Plovdiv EOOD
4004 Plovdiv
BulgariaRekrutierend» Google-Maps
Complex Oncology Center - Ruse EOOD
7002 Ruse
BulgariaRekrutierend» Google-Maps
Complex Oncology Center - Vratsa
3000 Vratsa
BulgariaRekrutierend» Google-Maps
Cross Cancer Institute
T6G 1Z2 Edmonton
CanadaNoch nicht rekrutierend» Google-Maps
Sunnybrook Research Institute
M4N 3M5 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
Sunnybrook Research Institute
M4N 3M5 Toronto
CanadaRekrutierend» Google-Maps
Unity Health Toronto, St. Michael's Hospital
M5B 1W8 Toronto
CanadaRekrutierend» Google-Maps
Unité de Recherche Clinique du CISSS des Laurentides
J7Z 2V4 St-Jerome
CanadaRekrutierend» Google-Maps
Unité de Recherche Clinique du CISSS des Laurentides
J7Z 5T3 St-Jerome
CanadaRekrutierend» Google-Maps
Anhui Provincial Hospital
230001 Hefei
ChinaNoch nicht rekrutierend» Google-Maps
Anhui Provincial Cancer Hospital
230031 Hefei
ChinaRekrutierend» Google-Maps
Fujian Medical University Union Hospital-1 Bingfanglou
350001 Fuzhou Fujian
ChinaNoch nicht rekrutierend» Google-Maps
Sun Yat-sen University Cancer Center
510060 Guangzhou
ChinaRekrutierend» Google-Maps
Guangxi Medical University Affiliated Tumor Hospital
530021 Nanning
ChinaRekrutierend» Google-Maps
Wuhan Union Hospital Cancer Center
430022 Wuhan
ChinaRekrutierend» Google-Maps
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
210031 Nanjing
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of Soochow University
215004 Suzhou
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Nanchang University
330006 Nanchang
ChinaRekrutierend» Google-Maps
The First Hospital of Jilin University
130021 Changchun
ChinaNoch nicht rekrutierend» Google-Maps
The First Hospital of China Medical University
110001 Shenyang
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of Xi'an Jiaotong University
710004 Xi'an
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of Xi'an Jiaotong University
710004 Xi'an
ChinaNoch nicht rekrutierend» Google-Maps
The Second Affiliated Hospital of Xi'an Jiaotong University
710004 Xi'an
ChinaRekrutierend» Google-Maps
Shandong Cancer Hospital
250117 Jinan
ChinaNoch nicht rekrutierend» Google-Maps
Ruijin Hospital Shanghai Jiaotong University School of Medicine
200025 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Fudan University Shanghai Cancer Center
200032 Shanghai
ChinaRekrutierend» Google-Maps
Yunnan Province Cancer Hospital
650106 Kunming
ChinaNoch nicht rekrutierend» Google-Maps
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
310016 Hangzhou
ChinaRekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
The Second Affiliated hospital of Zhejiang University school of medicine
310052 Hangzhou
ChinaRekrutierend» Google-Maps
Fakultní nemocnice Brno Bohunice
625 00 Brno
CzechiaRekrutierend» Google-Maps
Fakultni Thomayerova nemocnice
14059 Prague
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice Kralovske Vinohrady
10034 Praha 10
CzechiaRekrutierend» Google-Maps
Tampereen yliopistollinen sairaala
33520 Tampere
FinlandNoch nicht rekrutierend» Google-Maps
Vaasan Keskussairaala
65130 Vaasa
FinlandNoch nicht rekrutierend» Google-Maps
Oulun yliopistollinen sairaala
90220 Oulu
FinlandNoch nicht rekrutierend» Google-Maps
Satakunnan Keskussairaala
28500 Pori
FinlandNoch nicht rekrutierend» Google-Maps
Centre Georges François Leclerc
21079 Dijon
FranceRekrutierend» Google-Maps
Institut de Cancérologie de l'Ouest
44805 Saint Herblain
FranceRekrutierend» Google-Maps
Institut de Cancérologie de l'Ouest
49055 ANGERS cedex 02
FranceRekrutierend» Google-Maps
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
63011 Clermont-Ferrand
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Poitiers
86021 Poitiers
FranceRekrutierend» Google-Maps
Alexandra General Hospital of Athens
115 28 Athens
GreeceRekrutierend» Google-Maps
Attikon General University Hospital
12462 Chaidari/Athens
GreeceNoch nicht rekrutierend» Google-Maps
University General Hospital of Heraklion
715 00 Heraklion
GreeceNoch nicht rekrutierend» Google-Maps
University General Hospital of Larissa
41110 Larissa
GreeceRekrutierend» Google-Maps
Budapesti Uzsoki Utcai Kórház
1145 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
City Cancer Centre - Vijayawada
520002 Vijayawada
IndiaRekrutierend» Google-Maps
All India Institute of Medical Sciences
110029 New Delhi
IndiaNoch nicht rekrutierend» Google-Maps
Rajiv Gandhi Cancer Institute And Research Centre
110085 New Delhi
IndiaRekrutierend» Google-Maps
Tata Memorial Hospital
400012 Mumbai
IndiaNoch nicht rekrutierend» Google-Maps
Sahyadri Super Speciality Hospital, Hadapsar
411028 Pune
IndiaNoch nicht rekrutierend» Google-Maps
Bhakti Vedanta Hospital and Research Institute
401107 Thane
IndiaRekrutierend» Google-Maps
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
700020 Kolkata
IndiaRekrutierend» Google-Maps
Yitzhak Shamir Medical Center
70300 Zerifin
IsraelRekrutierend» Google-Maps
Istituto Nazionale Tumori IRCCS Fondazione Pascale
80131 Napoli
ItalyRekrutierend» Google-Maps
Humanitas Istituto Clinico Catanese
95045 Misterbianco
ItalyRekrutierend» Google-Maps
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
40138 Bologna
ItalyRekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuor
00168 Roma
ItalyRekrutierend» Google-Maps
Fondazione IRCCS San Gerardo dei Tintori
20900 Monza
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria delle Marche
60126 Ancona
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Pisana
56126 Pisa
ItalyRekrutierend» Google-Maps
Ospedale Generale Provinciale Macerata
62100 Macerata
ItalyRekrutierend» Google-Maps
Istituto Europeo di Oncologia IRCCS
20141 Milano
ItalyRekrutierend» Google-Maps
Istituto Oncologico Veneto IRCCS
35128 Padova
ItalyRekrutierend» Google-Maps
Aichi Cancer Center Hospital
464-8681 Nagoya
JapanRekrutierend» Google-Maps
Nagoya City University Hospital
467-8602 Nagoya
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa
JapanRekrutierend» Google-Maps
National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo
JapanRekrutierend» Google-Maps
Saitama Prefectural Cancer Center
362-0806 Ina-machi
JapanRekrutierend» Google-Maps
Juntendo University Hospital
113-8431 Bunkyo-ku
JapanRekrutierend» Google-Maps
Tokyo Metropolitan Komagome Hospital, Department of Breast Surgery
113-8677 Bunkyo-ku
JapanRekrutierend» Google-Maps
Cancer Institute Hospital of JFCR
135-8550 Koto-ku
JapanRekrutierend» Google-Maps
Japanese Foundation for Cancer Research
135-8550 Koto
JapanRekrutierend» Google-Maps
National Center for Global Health and Medicine
162-8655 Shinjuku City
JapanRekrutierend» Google-Maps
Center Hospital of the National Center for Global Health and Medicine
162-8655 Shinjuku-ku
JapanRekrutierend» Google-Maps
Center Hospital of the National Center for Global Health and Medicine
162-8655 Shinjyuku-ku
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka
JapanRekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Namdong-gu
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam
Korea, Republic ofRekrutierend» Google-Maps
Ajou University Hospital
16499 Suwon
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, Yonsei University Health System
06273 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic Univ. of Korea Seoul St. Mary's Hospital
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ewha Womans University Mokdong Hospital
Seoul
Korea, Republic ofRekrutierend» Google-Maps
Akershus Universitetssykehus
1474 Lorenskog
NorwayNoch nicht rekrutierend» Google-Maps
Drammen Sykehus, Vestre Viken HF
3004 Drammen
NorwayNoch nicht rekrutierend» Google-Maps
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
02-781 Warszawa
PolandNoch nicht rekrutierend» Google-Maps
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
30-348 Kraków
PolandRekrutierend» Google-Maps
COPERNICUS PL, Wojewodzkie Centrum Onkologii
80-219 Gdansk
PolandRekrutierend» Google-Maps
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
90-338 Lodz
PolandRekrutierend» Google-Maps
Puerto Rico Medical Research Center
00917 Hato Rey
Puerto RicoRekrutierend» Google-Maps
Pan American Center for Oncology Trials, LLC
00935 Rio Piedras
Puerto RicoRekrutierend» Google-Maps
Pan American Center for Oncology Trials- Hospital Oncologico
00935 Rio Piedras
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Studien-Informationen

Detailed Description:

The purpose of this study is to learn about the safety and effects of the study medicine

ARV-471 (PF-07850327, vepdegestrant) compared to fulvestrant (FUL) in participants with

advanced breast cancer. Advanced breast cancer is difficult to cure or control with

treatment. The cancer may have spread from where it first started to nearby tissue, lymph

nodes, or distant parts of the body, i.e. bones, lungs, brain, or liver. FUL is a medicine

already used for treatment of breast cancer while ARV-471 is a new medicine.

This study is seeking participants with breast cancer who:

- have cancer that has come back in the place where it started or spread to nearby tissue,

lymph nodes, or distant parts of the body.

- cannot be fully cured by surgery or radiation therapy. Radiation therapy is the use of

high-energy radiation such as x-rays, gamma rays and other sources to kill cancer cells

and shrink tumors.

- respond to hormonal or endocrine therapy (which target hormones and/or activity of

hormone receptors) such as tamoxifen or aromatase inhibitors (this is called estrogen

receptor positive disease)

- have received one line of CDK4/6 inhibitor therapy (for example palbociclib, ribociclib

or abemaciclib) in combination with endocrine therapy (for example letrozole) for

advanced cancer.

- are allowed up to one other endocrine therapy (for example exemestane) for advanced

cancer.

Half of the participants will be given ARV-471 while the other half of the participants will

be given FUL.

Participants who get ARV-471 will take ARV-471 by mouth with food, one time a day. During the

first treatment cycle participants who will get FUL will be given FUL by shots into the

muscles on Day 1 and again 2 weeks later. After the first month, FUL shots will be given on

the first day of each new treatment cycle. One treatment cycle is 28 days.

Participants will receive the study medicine until their breast cancer worsens or side

effects become too severe. Participants will have visits at the study clinic about every 4

weeks.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Adult participants with loco-regional recurrent or metastatic breast disease not

amenable to surgical resection or radiation therapy

- Confirmed diagnosis of ER+/HER2- breast cancer

- Prior therapies for locoregional recurrent or metastatic disease must fulfill all the

following criteria:

- One line of CDK4/6 inhibitor therapy in combination with endocrine therapy. Only one

line of CDK4/6 inhibitor is allowed in any setting.

- ≤ 1 endocrine therapy in addition to CDK4/6 inhibitor with ET

- Most recent endocrine treatment duration must have been given for ≥6 months prior to

disease progression. This may be the endocrine treatment component of the CDK4/6

inhibitor line of therapy.

- Radiological progression during or after the last line of therapy.

- Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors

(RECIST) v.1.1 or non-measurable bone-only disease

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

- Participants should be willing to provide blood and tumor tissue

Exclusion Criteria:

- Participants with advanced, symptomatic visceral spread, that are at risk of

life-threatening complications in the short term

- Prior treatment with:

- ARV-471, fulvestrant, elacestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor

for any setting

- other investigational agents (including novel endocrine therapy any SERDs, SERCAs,

CERANs) for any setting

- prior chemotherapy for advanced/metastatic disease

- Inadequate liver, kidney and bone marrow function

- Active brain metastases

- Participants with significant concomitant illness

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) (Time Frame - From randomization date (every 8 weeks for the first 48 weeks and then every 12 weeks thereafter) to date of first documentation of progression OR death (approximately 2 years).):
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.



Secondary outcome:

1. Overall survival (OS) (Time Frame - From randomization date (every 3 months) to date of death (approximately 3 years)):
Overall survival is defined as the time interval from the date of randomization to the date of documented death due to any cause.

2. Objective Response Rate (ORR) (Time Frame - From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death (approximately to 2 years).):
Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1, from the date of randomization to the date of disease progression, death due to any cause, whichever occurs first.

3. Duration of response (DR) (Time Frame - From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) to the date of disease progression or death (approximately to 2 years).):
Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by BICR assessment as per RECIST 1.1 or death due to any cause, whichever occurs first.

4. Clinical Benefit Rate (Time Frame - From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression or death (approximately to 2 years).):
Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR at any time, or SD or nonCR/non PD for at least 24 weeks determined by BICR assessment as per RECIST 1.1, from the date of randomization until disease progression, death due to any cause, whichever occurs first.

5. Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), electrocardiogram (ECG) and laboratory abnormalities (Time Frame - From screening until 28 days after the last dose (approximately 2 years).):
Incidence of participants with TEAEs, SAEs ECGs and laboratory abnormalities. TEAE/SAE and laboratory abnormalities will be graded according to NCI CTCAE V5.

6. QT Interval (QTc) (Time Frame - From baseline to end of treatment (approximately 2 years).):
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) are performed.

7. Plasma Concentration Versus Time of ARV-471 (Time Frame - From randomization date up to cycle 7 (each cycle is 28 days).):
Plasma concentrations of ARV-471

8. Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) (Time Frame - From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).):
Change from baseline and time to deterioration between treatment comparison in Quality of Life using the EQ-5D 5L questionnaire.

9. Disease-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30) (Time Frame - From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).):
Change from baseline and time to deterioration between treatment comparison in Quality of Life using the EORTC QLQ-C30 questionnaire.

10. Disease- and treatment-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer module (QLQ-BR23) questionnaire (Time Frame - From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).):
Change from baseline and time to deterioration between treatment comparison in Quality of Life Using the EORTC QLQ-BR23 (Breast) questionnaire.

11. Clinical Pain and its impact on functioning will be assessed using Brief Pain Inventory Short Form (BPI-SF) questionnaire. (Time Frame - From screening and every cycle until cycle 6 (cycle=28 days) and then every other cycle until 28 days after the last dose (appr. 2 yrs).The modified BPI-SF (worst pain severity and pain interference) daily from baseline until the EOT (appr 2 yrs)):
Change from baseline and time to deterioration between treatment comparison in Brief Pain Inventory Short Form questionnaire.

12. circulating deoxyribonucleic acid (DNA) (Time Frame - From baseline to end of treatment (approximately 2 years).):
Quantitative changes from baseline

Studien-Arme

  • Experimental: ARV-471
  • Active Comparator: Fulvestrant

Geprüfte Regime

  • ARV-471 (PF-07850327):
    orally, once daily on a 28-day continuous dosing schedule
  • Fulvestrant:
    intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from C2D1 (28-day cycle)

Quelle: ClinicalTrials.gov


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"A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer."

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