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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

624

Participants

Timeline

Start Date

March 3, 2023

Primary Completion Date

January 31, 2025

Study Completion Date

May 15, 2028

Conditions
Advanced Breast Cancer
Interventions
DRUG

ARV-471

orally, once daily on a 28-day continuous dosing schedule

DRUG

Fulvestrant

intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from C2D1 (28-day cycle)

Trial Locations (312)

112

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

116

Taipei Municipal Wan Fang Hospital, Taipei

333

Chang Gung Medical Foundation-Linkou Branch, Taoyuan District

704

National Cheng Kung University Hospital, Tainan City

1125

Fundación Cenit Para La Investigación En Neurociencias, CABA

1145

Budapesti Uzsoki Utcai Kórház, Budapest

1200

Cliniques universitaires Saint-Luc, Woluwe-Saint-Lambert

1417

Instituto de Oncología Angel H. Roffo, CABA

1426

Centro Oncologico Korben, Buenos Aires

1431

"Centro de Educación Médica e Investigaciones clínicas Dr. Norberto Quirno (CEMIC)", Buenos Aires

2000

Fundacion Estudios Clinicos, Rosario

2193

Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg

WCR Office, Johannesburg

Wits Clinical Research, Johannesburg

2450

Coffs Harbour Health Campus, Coffs Harbour

2650

Antwerp University Hospital, Edegem

3000

UZ Leuven, Leuven

3144

Cabrini Hospital - Malvern, Malvern

3186

Cabrini Hospital -Brighton, Brighton

3220

Barwon Health, Geelong

4000

Clinical Chc Montlégia, Liège

4004

Complex Oncology Center - Plovdiv EOOD, Plovdiv

4102

Princess Alexandra Hospital, Woolloongabba

4575

Sunshine Coast University Private Hospital, Birtinya

5000

Tumor Zentrum Aarau, Aarau

5020

Uniklinikum Salzburg, Salzburg

5037

ICON Cancer Centre - Kurralta Park, Kurralta Park

6060

Grand Hôpital de Charleroi, Gilly

7000

Icon Cancer Centre Hobart, Hobart

8000

Complex Oncology Center - Burgas, Burgas

8036

Medizinische Universität Graz, Graz

8423

Althaia, Xarxa Assistencial Universitària de Manresa, Manresa

8500

Kantonsspital Frauenfeld - Spital Thurgau AG, Frauenfeld

9024

Petz Aladar Egyetemi Oktato Korhaz, Győr

9301

Iatros International, Bloemfontein

10002

National Taiwan University Hospital, Taipei

10034

Fakultni nemocnice Kralovske Vinohrady, Prague

10065

Memorial Sloan Kettering Cancer Center, New York

MSK Evelyn H. Lauder Breast and Imaging Center, New York

10408

National Cancer Center, Goyang-si

10449

Mackay Memorial Hospital, Taipei

10549

Northern Westchester Hospital, Mount Kisco

10591

Phelps Hospital, Sleepy Hollow

10604

MSK Westchester, Harrison

10707

Onkologische Schwerpunktpraxis Kurfuerstendamm, Berlin

10960

Hematology Oncology Associates of Rockland, Nyack

11042

R.J. Zuckerberg Cancer Center, Lake Success

11217

Taipei Veterans General Hospital, Taipei

11553

MSK Nassau, Uniondale

11725

MSK Commack, Commack

11883

Södersjukhuset, Stockholm

12462

Attikon General University Hospital, Chaidari/Athens

13031

Hematology Oncology Associates of CNY, Camillus

13057

Hematology-Oncology Associates of Central New York, PC, East Syracuse

13620

Seoul National University Bundang Hospital, Seongnam

14059

Fakultni Thomayerova nemocnice, Prague

15006

CHUAC-Hospital Teresa Herrera, A Coruña

16499

Ajou University Hospital, Suwon

18012

Hospital Universitario Virgen Nieves, Granada

18016

Hospital Universitario San Cecilio, Granada

20014

Hospital Universitario Donostia, Donostia / San Sebastian

20141

Istituto Europeo di Oncologia IRCCS, Milan

20900

Fondazione IRCCS San Gerardo dei Tintori, Monza

21079

Centre Georges François Leclerc, Dijon

21565

Gachon University Gil Medical Center, Namdong-gu

22030

Trakya University Medical Faculty Hospital, Edirne

22903

University of Virginia Cancer Center, Charlottesville

22908

University of Virginia Health System, Charlottesville

22911

UVA Breast Care Center, Charlottesville

23114

Bon Secours St. Francis Medical Center, Midlothian

23116

Bon Secours Memorial Regional Medical Center, Mechanicsville

23226

Bon Secours St. Mary's Hospital, Richmond

25198

Hospital Universitario Arnau de Vilanova de Lleida, Lleida

26504

University Hospital of Patras, Pátrai

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28050

Hospital Universitario HM Sanchinarro, Madrid

28500

Satakunnan Keskussairaala, Pori

29010

Hospital Universitario Virgen de la Victoria, Málaga

32117

Florida Cancer Specialists, Daytona Beach

32159

Florida Cancer Specialists, The Villages

32605

Florida Cancer Specialists, Gainesville

32701

Florida Cancer Specialists, Altamonte Springs

32763

Florida Cancer Specialists, Orange City

32778

Florida Cancer Specialists, Tavares

32789

Florida Cancer Specialists, Winter Park

32806

Florida Cancer Specialists, Orlando

32960

Florida Cancer Specialists, Vero Beach

33401

Florida Cancer Specialists, West Palm Beach

33414

Florida Cancer Specialists, Wellington

33511

Florida Cancer Specialists, Brandon

33520

Tampereen yliopistollinen sairaala, Tampere

33607

Florida Cancer Specialists, Tampa

33705

Florida Cancer Specialists, St. Petersburg

33756

Morton Plant Hospital - BayCare Health System, Clearwater

33761

Florida Cancer Specialists, Clearwater

33770

Florida Cancer Specialists, Largo

33805

Lakeland Regional Cancer Center, Lakeland

33905

Florida Cancer Specialists COL, Fort Myers

33908

Florida Cancer Specialists GLO, Fort Myers

33909

Florida Cancer Specialists NFM, Cape Coral

33980

Florida Cancer Specialists PCH, Port Charlotte

34070

Centre de Cancérologie du Grand Montpellier, Montpellier

34102

Florida Cancer Specialists NGD, Naples

34135

Florida Cancer Specialists BON, Bonita Springs

34205

Florida Cancer Specialists BCC, Bradenton

34211

Florida Cancer Specialists LRS, Bradenton

34232

Florida Cancer Specialists SAC, Sarasota

34236

Florida Cancer Specialists SAD, Sarasota

34275

Florida Cancer Specialist And Research Institute, N. Venice

34286

Florida Cnacer Specialists, North Port

34461

Florida Cancer Specialists, Lecanto

34474

Florida Cancer Specialists, Ocala

34655

Florida Cancer Specialist, Trinity

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul

34752

Acibadem Altunizade Hospital, Istanbul

34994

Florida Cancer Specialists, Stuart

35128

Istituto Oncologico Veneto IRCCS, Padua

35575

I.E.U. Medical Point Hastanesi, Izmir

39401

Hattiesburg Clinic Hematology/Oncology, Hattiesburg

40138

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, Bologna

40202

Norton Cancer Institute - Downtown, Louisville

Norton Cancer Institute, Downtown, Louisville

Norton Hospital, Louisville

40207

Norton Cancer Institute, St Matthews Campus, Louisville

Norton Women's & Children's Hospital, Louisville

40241

Norton Brownsboro Hospital, Louisville

Norton Cancer Institute, Brownsboro Hospital Campus, Louisville

40447

China Medical University Hospital, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

41110

University General Hospital of Larissa, Larissa

43204

Salut Sant Joan de Reus-Baix Camp (Edp), Reus

44124

Azienda Ospedaliero Universitaria di Ferrara, Cona

44600

Boca Clinical Trials Mexico S.C., Guadajalara

44805

Institut de Cancérologie de l'Ouest, Saint-Herblain

46014

Hospital General Universitario de Valencia, Valencia

48013

Osi Bilbao-Basurto, Bilbao

49055

Institut de Cancérologie de l'Ouest, Angers

55200

Samsun Medical Park Hastanesi, Samsun

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

60126

Azienda Ospedaliero Universitaria delle Marche, Ancona

60521

Hope and Healing Cancer Services, Hinsdale

62100

Ospedale Generale Provinciale Macerata, Macerata

63011

Mercy Clinic Oncology and Hematology, Ballwin

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne, Clermont-Ferrand

63141

Mercy Research - David C. Pratt Cancer Center, St Louis

64111

Saint Luke's Cancer Institute, Kansas City

65130

Vaasan Keskussairaala, Vaasa

68020

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

70112

University Medical Center New Orleans, New Orleans

71004

Chi Mei Medical Center, Tainan City

71103

Louisiana State University Health Sciences Shreveport, Shreveport

73505

Cancer Centers of Southwest Oklahoma, Lawton

73657

Chi Mei Hospital - Liouying Branch, Tainan City

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli

80756

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

83301

Chang Gung Memorial Hospital at Kaohsiung, Kaohsiung Niao Sung Dist

84918

Sainte Catherine Institut du Cancer Avignon Provence, Avignon

86021

Centre Hospitalier Universitaire de Poitiers, Poitiers

91342

Olive View-UCLA Medical Center, Sylmar

92024

California Cancer Associates for Research and Excellence, Inc. (cCARE), Encinitas

92069

California Cancer Associates for Research and Excellence, San Marcos

92708

Orange Coast Memorial Medical Center, Fountain Valley

93720

California Cancer Associates for Research and Excellence, Fresno

94000

Henri Mondor Hospital, Créteil

94558

Providence Queen of the Valley Medical Center, Napa

95045

Humanitas Istituto Clinico Catanese, Misterbianco

95801

Nemocnica na okraji mesta n o, Partizánske

97213

Providence Cancer Institute Franz Clinic, Portland

Providence Portland Medical Center, Portland

98055

UW Medicine Valley Medical Center, Renton

98503

Providence Regional Cancer System - Lacey, Lacey

98520

Providence Regional Cancer System - Aberdeen, Aberdeen

98531

Providence Regional Cancer System- Centralia, Centralia

100005

Beijing Hospital, Beijing

100021

Cancer Hospital Chinese Academy of Medical Science, Beijing

110001

The First Hospital of China Medical University, Shenyang

110042

Liaoning Cancer Hospital, Shenyang

110075

Venkateshwar Hospital, New Delhi

110085

Rajiv Gandhi Cancer Institute And Research Centre, New Delhi

116023

The 2nd Affiliated Hospital of Dalian Medical University, Dalian

122001

Artemis hospital, Gurgaon

130021

The First Hospital of Jilin University, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200025

Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

210031

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School, Nanjing

230001

Anhui Provincial Hospital, Hefei

230031

Anhui Provincial Cancer Hospital, Hefei

250117

Shandong Cancer Hospital, Jinan

300060

Tianjin Medical University Cancer Institute & Hospital, Tianjin

310016

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

310052

The Second Affiliated hospital of Zhejiang University school of medicine, Hangzhou

330006

The First Affiliated Hospital of Nanchang University, Nanchang

330009

Nanchang People's Hospital, Nanchang

350001

Fujian Medical University Union Hospital, Fuzhou Fujian

400012

Tata Memorial Hospital, Mumbai

401107

Bhakti Vedanta Hospital and Research Institute, Thāne

422002

HCG Manavata Cancer Centre, Nashik

422009

Apex Wellness Hospital, Nashik

430022

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

Wuhan Union Hospital Cancer Center, Wuhan

430040

Jinyinhu Branch of Tongji Medical College Affiliated Union Hospital, Huazhong University of Science, Wuhan

430079

Hubei Cancer Hospital, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

471003

The First Affiliated Hospital of Henan University of Science &Technology, Luoyang

510060

Sun Yat-sen University Cancer Center, Guangzhou

510555

Sun Yat-sen University Cancer Center, Guangzhou

528041

The First People's Hospital of Foshan, Foshan

530201

Guangxi Medical University Affiliated Tumor Hospital, Nanning

650106

Yunnan Province Cancer Hospital, Kunming

700020

Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata

710004

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

2418515

Kanagawa cancer center, Yokohama

4941492

Rabin Medical Center, Petah Tikva

7610001

Kaplan Medical Center, Rehovot

88501001

ANIMI - Unidade de Tratamento Oncologico, Lages

90560032

Hospital Moinhos de Vento, Porto Alegre

06824

Smilow Cancer Hospital Care Center at Fairfield, Fairfield

06510

Smilow Cancer Hospital at Yale-New Haven, New Haven

Yale-New Haven Hospital, New Haven

06473

Smilow Cancer Hospital Care Center at North Haven, North Haven

06611

Smilow Cancer Hospital Care Center at Trumbull, Trumbull

03756

Dartmouth-Hitchcock Medical Center, Lebanon

07920

MSK Basking Ridge, Basking Ridge

07748

MSK Monmouth, Middletown

07645

Memorial Sloan Kettering - Bergen, Montvale

B1884BBF

Centro de Oncología e Investigación de Buenos Aires, Berazategui

C1023AAB

Stat Research S.A., Ciudad Autónoma de Buenos Aires

S2000ORE

Sanatorio de La Mujer, Rosario

C1426ABP

Fundación Respirar, Buenos Aires

X5004FHP

Clínica Universitaria Reina Fabiola, Córdoba

29043-260

Hospital Santa Rita de Cassia, Vitória

98700-000

ONCOSITE - Centro de Pesquisa Clinica em Oncologia, Ijuí

90110-270

Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa, Porto Alegre

90610-000

Hospital São Lucas da PUCRS, Porto Alegre

90850-170

Centro de Pesquisa Clínica - Área Administrativa, Porto Alegre

90880-480

Hospital Mae de Deus, Porto Alegre

09060-650

Faculdade de Medicina do ABC, Santo André

01509-010

A. C. Camargo Cancer Center, São Paulo

03102002

IBCC - Instituto Brasileiro de Controle do Câncer, São Paulo

04014-002

IBCC - Núcleo de Pesquisa e Ensino, São Paulo

T6G 1Z2

Cross Cancer Institute, Edmonton

V3V 1Z2

BC Cancer Surrey, Surrey

E1C 6Z8

The Moncton Hospital, Moncton

N2G 1G3

Waterloo Regional Health Network, Kitchener

M4N 3M5

Sunnybrook Research Institute, Toronto

M5B 1W8

Unity Health Toronto, St. Michael's Hospital, Toronto

J7Y 0L1

Centre de Services Ambulatoires de St-Jerome, Saint-Jérôme

J7Z 2V4

Unité de Recherche Clinique du CISSS des Laurentides, Saint-Jérôme

625 00

Fakultní nemocnice Brno Bohunice, Brno

115 28

Alexandra General Hospital of Athens, Athens

715 00

University General Hospital of Heraklion, Heraklion

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome

464-8681

Aichi Cancer Center Hospital, Nagoya

466-8560

Nagoya University Hospital, Nagoya

467-8602

Nagoya City University Hospital, Nagoya

260-8717

Chiba cancer center, Chiba

277-8577

National Cancer Center Hospital East, Kashiwa

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

565-0871

Osaka University Hospital, Suita

362-0806

Saitama Prefectural Cancer Center, Ina-machi

113-8431

Juntendo University Hospital, Bunkyo-ku

113-8677

Tokyo Metropolitan Komagome Hospital, Department of Breast Surgery, Bunkyo-ku

135-8550

Cancer Institute Hospital of JFCR, Koto-ku

Japanese Foundation for Cancer Research, Koto

162-8655

National Center for Global Health and Medicine, Shinjuku

Center Hospital of the National Center for Global Health and Medicine, Shinjuku-ku

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

892-0833

Sagara Hospital, Kagoshima

700-8558

Okayama University Hospital, Okayama

06100

Cryptex Investigación Clínica S.A. de C.V., Cuauhtémoc

30-348

Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o., Krakow

31-501

SP ZOZ Szpital Uniwersytecki w Krakowie, Krakow

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie, Warsaw

80-219

COPERNICUS PL, Wojewodzkie Centrum Onkologii, Gdansk

90-338

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna, Lodz

00917

Puerto Rico Medical Research Center, Hato Rey

00935

Hospital Oncológico Dr. Isaac González-Martinez, Rio Piedras

Pan American Center for Oncology Trials, LLC, Rio Piedras

00927

FDI Clinical Research, San Juan

812 50

Onkologicky ustav sv. Alzbety, s.r.o., Bratislava

833 10

Narodny onkologicky ustav, Bratislava

04191

Vychodoslovensky onkologicky ustav, a.s., Košice

917 75

Fakultna nemocnica Trnava, Trnava

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic Univ. of Korea Seoul St. Mary's Hospital, Seoul

Unknown

Ewha Womans University Mokdong Hospital, Seoul

03203

Hospital General Universitario de Elche, Elche

08916

Institut Català d'Oncologia (ICO) - Badalona, Badalona

08003

Parc de Salut Mar - Hospital del Mar, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08908

Institut Català d'Oncologia - L'Hospitalet, L'Hospitalet de Llobregat

CH8596

Kantonsspital Münsterlingen - Spital Thurgau AG, Münsterlingen

06230

Hacettepe Universite Hastaneleri, Altindağ

01140

Adana Medical Park Seyhan Hastanesi, Adana

01370

Adana Sehir Egitim ve Arastirma Hastanesi, Adana

06010

Gulhane Egitim Arastirma Hastanesi, Ankara

06520

Memorial Ankara Hastanesi, Ankara

06800

Ankara Bilkent Şehir Hastanesi, Ankara

07059

Akdeniz Universitesi Hastanesi, Antalya

EC1A 7BE

St Bartholomew's Hospital, London

BB2 3HH

Royal Blackburn Hospital, Blackburn

G12 0YN

The Beatson West of Scotland Cancer Centre, Glasgow

M20 4GJ

The Christie Hospital NHS Foundation Trust, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Arvinas Estrogen Receptor, Inc.

INDUSTRY

lead

Pfizer

INDUSTRY

NCT05654623 - A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter