AzTrials
AzTrials

Advanced Breast CancerPhase 3VERITAC-2NCT05654623

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

A Phase 3 study testing ARV-471 and Fulvestrant in people with Advanced Breast Cancer, run by Pfizer at 312 sites in 31 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Breast Cancer
What is being tested?
ARV-471 and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
624 participants
Where
312 sitesin 31 countries
Study dates
3 Mar 2023to 15 May 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

312 sites in 31 countries.

312 sites in 31 countries

United States87 sites

  • Providence Regional Cancer System - Aberdeen

    Aberdeen, Washington, 98520

  • Florida Cancer Specialists

    Altamonte Springs, Florida, 32701

  • Mercy Clinic Oncology and Hematology

    Ballwin, Missouri, 63011

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Florida Cancer Specialists BON

    Bonita Springs, Florida, 34135

  • Florida Cancer Specialists BCC

    Bradenton, Florida, 34205

  • Florida Cancer Specialists LRS

    Bradenton, Florida, 34211

  • Florida Cancer Specialists

    Brandon, Florida, 33511

  • Hematology Oncology Associates of CNY

    Camillus, New York, 13031

  • Florida Cancer Specialists NFM

    Cape Coral, Florida, 33909

  • Providence Regional Cancer System- Centralia

    Centralia, Washington, 98531

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22903

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • UVA Breast Care Center

    Charlottesville, Virginia, 22911

  • Morton Plant Hospital - BayCare Health System

    Clearwater, Florida, 33756

  • Florida Cancer Specialists

    Clearwater, Florida, 33761

  • MSK Commack

    Commack, New York, 11725

  • Florida Cancer Specialists

    Daytona Beach, Florida, 32117

  • Hematology-Oncology Associates of Central New York, PC

    East Syracuse, New York, 13057

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

    Encinitas, California, 92024

  • Smilow Cancer Hospital Care Center at Fairfield

    Fairfield, Connecticut, 06824

  • Florida Cancer Specialists COL

    Fort Myers, Florida, 33905

  • Florida Cancer Specialists GLO

    Fort Myers, Florida, 33908

  • Orange Coast Memorial Medical Center

    Fountain Valley, California, 92708

  • California Cancer Associates for Research and Excellence

    Fresno, California, 93720

  • Florida Cancer Specialists

    Gainesville, Florida, 32605

  • MSK Westchester

    Harrison, New York, 10604

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Providence Regional Cancer System - Lacey

    Lacey, Washington, 98503

  • R.J. Zuckerberg Cancer Center

    Lake Success, New York, 11042

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Florida Cancer Specialists

    Largo, Florida, 33770

  • Cancer Centers of Southwest Oklahoma

    Lawton, Oklahoma, 73505

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Florida Cancer Specialists

    Lecanto, Florida, 34461

  • Norton Cancer Institute - Downtown

    Louisville, Kentucky, 40202

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202

  • Norton Hospital

    Louisville, Kentucky, 40202

  • Norton Cancer Institute, St Matthews Campus

    Louisville, Kentucky, 40207

  • Norton Women's & Children's Hospital

    Louisville, Kentucky, 40207

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241

  • Norton Cancer Institute, Brownsboro Hospital Campus

    Louisville, Kentucky, 40241

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

  • MSK Monmouth

    Middletown, New Jersey, 07748

  • Bon Secours St. Francis Medical Center

    Midlothian, Virginia, 23114

  • Memorial Sloan Kettering - Bergen

    Montvale, New Jersey, 07645

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Florida Cancer Specialist And Research Institute

    N. Venice, Florida, 34275

  • Providence Queen of the Valley Medical Center

    Napa, California, 94558

  • Florida Cancer Specialists NGD

    Naples, Florida, 34102

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • MSK Evelyn H. Lauder Breast and Imaging Center

    New York, New York, 10065

  • Smilow Cancer Hospital Care Center at North Haven

    North Haven, Connecticut, 06473

  • Florida Cnacer Specialists

    North Port, Florida, 34286

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • Florida Cancer Specialists

    Ocala, Florida, 34474

  • Florida Cancer Specialists

    Orange City, Florida, 32763

  • Florida Cancer Specialists

    Orlando, Florida, 32806

  • Florida Cancer Specialists PCH

    Port Charlotte, Florida, 33980

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • UW Medicine Valley Medical Center

    Renton, Washington, 98055

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia, 23226

  • California Cancer Associates for Research and Excellence

    San Marcos, California, 92069

  • Florida Cancer Specialists SAC

    Sarasota, Florida, 34232

  • Florida Cancer Specialists SAD

    Sarasota, Florida, 34236

  • Louisiana State University Health Sciences Shreveport

    Shreveport, Louisiana, 71103

  • Phelps Hospital

    Sleepy Hollow, New York, 10591

  • Mercy Research - David C. Pratt Cancer Center

    St Louis, Missouri, 63141

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists

    Stuart, Florida, 34994

  • Olive View-UCLA Medical Center

    Sylmar, California, 91342

  • Florida Cancer Specialists

    Tampa, Florida, 33607

  • Florida Cancer Specialists

    Tavares, Florida, 32778

  • Florida Cancer Specialists

    The Villages, Florida, 32159

  • Florida Cancer Specialist

    Trinity, Florida, 34655

  • Smilow Cancer Hospital Care Center at Trumbull

    Trumbull, Connecticut, 06611

  • MSK Nassau

    Uniondale, New York, 11553

  • Florida Cancer Specialists

    Vero Beach, Florida, 32960

  • Florida Cancer Specialists

    Wellington, Florida, 33414

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • Florida Cancer Specialists

    Winter Park, Florida, 32789

Other trials in United States

China33 sites

  • Beijing Hospital

    Beijing, Beijing Municipality, 100005

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The 2nd Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528041

  • Fujian Medical University Union Hospital

    Fuzhou Fujian, Fujian, 350001

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510555

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • The Second Affiliated hospital of Zhejiang University school of medicine

    Hangzhou, Zhejiang, 310052

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Yunnan Province Cancer Hospital

    Kunming, Yunnan, 650106

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan, 471003

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanchang People's Hospital

    Nanchang, Jiangxi, 330009

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

    Nanjing, Jiangsu, 210031

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530201

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Wuhan Union Hospital Cancer Center

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430040

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Spain19 sites

  • CHUAC-Hospital Teresa Herrera

    A Coruña, A Coruña [LA Coruña], 15006

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [barcelona], 08916

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, Barcelona [barcelona], 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035

  • Osi Bilbao-Basurto

    Bilbao, Basque Country, 48013

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Universitario Virgen Nieves

    Granada, 18012

  • Hospital Universitario San Cecilio

    Granada, 18016

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet de Llobregat, Catalunya [cataluña], 08908

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, Lleida [lérida], 25198

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

  • Althaia, Xarxa Assistencial Universitària de Manresa

    Manresa, 8423

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

    Reus, Tarragona [tarragona], 43204

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Japan18 sites

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Tokyo Metropolitan Komagome Hospital, Department of Breast Surgery

    Bunkyo-ku, Tokyo, 113-8677

  • Chiba cancer center

    Chiba, Chiba, 260-8717

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Saitama Prefectural Cancer Center

    Ina-machi, Saitama, 362-0806

  • Sagara Hospital

    Kagoshima, 892-0833

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Okayama University Hospital

    Okayama, 700-8558

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • National Center for Global Health and Medicine

    Shinjuku, Tokyo, 162-8655

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-ku, Tokyo, 162-8655

  • Osaka University Hospital

    Suita, Osaka, 565-0871

  • Kanagawa cancer center

    Yokohama, Kanagawa, 2418515

Other trials in Japan

Brazil12 sites

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia

    Ijuí, Rio Grande do Sul, 98700-000

  • ANIMI - Unidade de Tratamento Oncologico

    Lages, Santa Catarina, 88501001

  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560032

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Centro de Pesquisa Clínica - Área Administrativa

    Porto Alegre, Rio Grande do Sul, 90850-170

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90880-480

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

  • A. C. Camargo Cancer Center

    São Paulo, São Paulo, 01509-010

  • IBCC - Instituto Brasileiro de Controle do Câncer

    São Paulo, 03102002

  • IBCC - Núcleo de Pesquisa e Ensino

    São Paulo, 04014-002

  • Hospital Santa Rita de Cassia

    Vitória, Espírito Santo, 29043-260

Other trials in Brazil

South Korea12 sites

  • National Cancer Center

    Goyang-si, Kyǒnggi-do, 10408

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [incheon], 21565

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

  • Korea University Anam Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 02841

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 05505

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 06273

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351

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

    Seoul, Seoul-teukbyeolsi [seoul], 06591

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul-teukbyeolsi [seoul]

  • Ajou University Hospital

    Suwon, Kyǒnggi-do, 16499

Other trials in South Korea

Taiwan12 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

  • China Medical University Hospital

    Taichung, 40447

  • Chi Mei Medical Center

    Tainan, Tainan, 71004

  • Chi Mei Hospital - Liouying Branch

    Tainan, Tainan, 73657

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

  • Mackay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Taipei Municipal Wan Fang Hospital

    Taipei, 116

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)12 sites

  • Adana Medical Park Seyhan Hastanesi

    Adana, 01140

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana, 01370

  • Hacettepe Universite Hastaneleri

    Altindağ, Ankara, 06230

  • Gulhane Egitim Arastirma Hastanesi

    Ankara, 06010

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Ankara Bilkent Şehir Hastanesi

    Ankara, 06800

  • Akdeniz Universitesi Hastanesi

    Antalya, 07059

  • Trakya University Medical Faculty Hospital

    Edirne, 22030

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, İ̇stanbul, 34722

  • Acibadem Altunizade Hospital

    Istanbul, İ̇stanbul, 34752

  • I.E.U. Medical Point Hastanesi

    Izmir, İ̇zmir, 35575

  • Samsun Medical Park Hastanesi

    Samsun, 55200

Other trials in Turkey (Türkiye)

Italy11 sites

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, The Marches, 60126

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

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliero Universitaria di Ferrara

    Cona, Ferrara, 44124

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141

  • Humanitas Istituto Clinico Catanese

    Misterbianco, Catania, 95045

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardy, 20900

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, Campania, 80131

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126

  • Ospedale Generale Provinciale Macerata

    Province of Macerata, 62100

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

    Rome, Lazio, 00168

Other trials in Italy

Argentina10 sites

  • Centro de Oncología e Investigación de Buenos Aires

    Berazategui, Buenos Aires, B1884BBF

  • Centro Oncologico Korben

    Buenos Aires, 1426

  • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

    Buenos Aires, 1431

  • Fundación Respirar

    Buenos Aires, C1426ABP

  • Instituto de Oncología Angel H. Roffo

    CABA, Buenos Aires, 1417

  • Fundación Cenit Para La Investigación En Neurociencias

    CABA, Buenos Aires F.D., 1125

  • Stat Research S.A.

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1023AAB

  • Clínica Universitaria Reina Fabiola

    Córdoba, X5004FHP

  • Fundacion Estudios Clinicos

    Rosario, Santa Fe Province, 2000

  • Sanatorio de La Mujer

    Rosario, Santa Fe Province, S2000ORE

Other trials in Argentina

Australia8 sites

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, 4575

  • Cabrini Hospital -Brighton

    Brighton, Victoria, 3186

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales, 2450

  • Barwon Health

    Geelong, Victoria, 3220

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000

  • ICON Cancer Centre - Kurralta Park

    Kurralta Park, South Australia, 5037

  • Cabrini Hospital - Malvern

    Malvern, Victoria, 3144

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada8 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Waterloo Regional Health Network

    Kitchener, Ontario, N2G 1G3

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Centre de Services Ambulatoires de St-Jerome

    Saint-Jérôme, Quebec, J7Y 0L1

  • Unité de Recherche Clinique du CISSS des Laurentides

    Saint-Jérôme, Quebec, J7Z 2V4

  • BC Cancer Surrey

    Surrey, British Columbia, V3V 1Z2

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • Unity Health Toronto, St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

France8 sites

  • Institut de Cancérologie de l'Ouest

    Angers, Maine-et-loire, 49055

  • Sainte Catherine Institut du Cancer Avignon Provence

    Avignon, Vaucluse, 84918

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

    Clermont-Ferrand, Puy-de-dôme, 63011

  • Henri Mondor Hospital

    Créteil, Île-de-France Region, 94000

  • Centre Georges François Leclerc

    Dijon, Côte-d'or, 21079

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, Languedoc-roussillon, 34070

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne, 86021

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Loire-atlantique, 44805

Other trials in France

India8 sites

  • Artemis hospital

    Gurgaon, Haryana, 122001

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

    Kolkata, West Bengal, 700020

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422002

  • Apex Wellness Hospital

    Nashik, Maharashtra, 422009

  • Venkateshwar Hospital

    New Delhi, National Capital Territory of Delhi, 110075

  • Rajiv Gandhi Cancer Institute And Research Centre

    New Delhi, National Capital Territory of Delhi, 110085

  • Bhakti Vedanta Hospital and Research Institute

    Thane, Maharashtra, 401107

Other trials in India

Belgium5 sites

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650

  • Grand Hôpital de Charleroi

    Gilly, Hainaut, 6060

  • UZ Leuven

    Leuven, Vlaams-brabant, 3000

  • Clinical Chc Montlégia

    Liège, 4000

  • Cliniques universitaires Saint-Luc

    Woluwe-Saint-Lambert, Bruxelles-capitale, Région de, 1200

Other trials in Belgium

Greece5 sites

  • Alexandra General Hospital of Athens

    Athens, Attikí, 115 28

  • Attikon General University Hospital

    Chaidari/Athens, Attikí, 12462

  • University General Hospital of Heraklion

    Heraklion, Irakleío, 715 00

  • University General Hospital of Larissa

    Larissa, Thessalía, 41110

  • University Hospital of Patras

    Pátrai, Achaḯa, 26504

Other trials in Greece

Poland5 sites

  • COPERNICUS PL, Wojewodzkie Centrum Onkologii

    Gdansk, Pomeranian Voivodeship, 80-219

  • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.

    Krakow, Lesser Poland Voivodeship, 30-348

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-501

  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, Łódź Voivodeship, 90-338

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Slovakia5 sites

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

    Bratislava, 812 50

  • Narodny onkologicky ustav

    Bratislava, 833 10

  • Vychodoslovensky onkologicky ustav, a.s.

    Košice, 04191

  • Nemocnica na okraji mesta n o

    Partizánske, 95801

  • Fakultna nemocnica Trnava

    Trnava, 917 75

Other trials in Slovakia

Puerto Rico4 sites

  • Puerto Rico Medical Research Center

    Hato Rey, Puerto RICO, 00917

  • Hospital Oncológico Dr. Isaac González-Martinez

    Rio Piedras, 00935

  • Pan American Center for Oncology Trials, LLC

    Rio Piedras, 00935

  • FDI Clinical Research

    San Juan, 00927

Other trials in Puerto Rico

South Africa4 sites

  • Iatros International

    Bloemfontein, Free State, 9301

  • Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, Gauteng, 2193

  • WCR Office

    Johannesburg, Gauteng, 2193

  • Wits Clinical Research

    Johannesburg, Gauteng, 2193

Other trials in South Africa

United Kingdom4 sites

  • Royal Blackburn Hospital

    Blackburn, BB2 3HH

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • St Bartholomew's Hospital

    London, London, CITY of, EC1A 7BE

  • The Christie Hospital NHS Foundation Trust

    Manchester, M20 4GJ

Other trials in United Kingdom

Czechia3 sites

  • Fakultní nemocnice Brno Bohunice

    Brno, Brno-město, 625 00

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4, 14059

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

Other trials in Czechia

Finland3 sites

  • Satakunnan Keskussairaala

    Pori, 28500

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa, 33520

  • Vaasan Keskussairaala

    Vaasa, Pohjanmaa, 65130

Other trials in Finland

Mexico3 sites

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Mexico City, 06100

  • Boca Clinical Trials Mexico S.C.

    Guadajalara, Jalisco, 44600

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

Other trials in Mexico

Switzerland3 sites

  • Tumor Zentrum Aarau

    Aarau, Canton of Aargau, 5000

  • Kantonsspital Frauenfeld - Spital Thurgau AG

    Frauenfeld, Thurgau, 8500

  • Kantonsspital Münsterlingen - Spital Thurgau AG

    Münsterlingen, Thurgau, CH8596

Other trials in Switzerland

Austria2 sites

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Uniklinikum Salzburg

    Salzburg, 5020

Other trials in Austria

Bulgaria2 sites

  • Complex Oncology Center - Burgas

    Burgas, 8000

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004

Other trials in Bulgaria

Hungary2 sites

  • Budapesti Uzsoki Utcai Kórház

    Budapest, 1145

  • Petz Aladar Egyetemi Oktato Korhaz

    Győr, Győr-Moson-Sopron, 9024

Other trials in Hungary

Israel2 sites

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492

  • Kaplan Medical Center

    Rehovot, Central District, 7610001

Other trials in Israel

Germany1 site

  • Onkologische Schwerpunktpraxis Kurfuerstendamm

    Berlin, 10707

Other trials in Germany

Sweden1 site

  • Södersjukhuset

    Stockholm, Stockholms LÄN [se-01], 11883

Other trials in Sweden

About this study

Official title: A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)

A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.

Read the 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.

Being tested
ARV-471, Fulvestrant
Keywords
ER(+)/HER2(-) Advanced Breast Cancer, Advanced cancer of the breast, Breast neoplasm, Breast tumor, Breast cancer, Fulvestrant, Estrogen receptor positive, Metastatic breast cancer, ER degrader, PROTAC, Hormone Therapy, Hormone positive breast cancer, Endocrine therapy, Recurrent breast cancer, HR+, HER2-negative, Vepdegestrant
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARV-471Drug

    Also called PF-07850327

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

  • FulvestrantDrug

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

Study groups in NCT05654623
Study groupRoleWhat they receive
ARV-471ExperimentalNot described
Receives: Drug: ARV-471
FulvestrantActive comparatorNot described
Receives: Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants

    PFS assessed by BICR was defined as the time from the date of randomization to the date of the first documentation of objective progression of disease (PD) per RECIST v1.1, or death due to any cause, whichever occurred first. PD as per RECIST v1.1 was defined as at least a 20% increase in the sum of diameters of target measurable lesions above nadir (smallest sum observed considering baseline and all assessments prior to the timepoint under evaluation), with a minimum absolute increase of 5 millimeters (mm) relative to nadir or unequivocal progression of existing non-target lesions or the presence of new lesions. PFS was censored on the date of last adequate disease assessment for those who did not have a PFS event, discontinued the study treatment due to withdrawal of consent prior to an event, started a new anticancer therapy prior to an event, had an event after a gap of 2 or more missing disease assessments, or lost to follow-up. Kaplan-Meier method was used.

    Measured: From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)

  2. PFS by BICR Assessment Per RECIST v1.1-Participants With ESR1 Mutation

    PFS assessed by BICR was defined as the time from the date of randomization to the date of the first documentation of objective PD per RECIST v1.1, or death due to any cause, whichever occurred first. PD as per RECIST v1.1 was defined as at least a 20% increase in the sum of diameters of target measurable lesions above nadir (smallest sum observed considering baseline and all assessments prior to the timepoint under evaluation), with a minimum absolute increase of 5 mm relative to nadir or unequivocal progression of existing non-target lesions or the presence of new lesions. PFS was censored on the date of last adequate disease assessment for those who did not have a PFS event, discontinued the study treatment due to withdrawal of consent prior to an event, started a new anticancer therapy prior to an event, had an event after a gap of 2 or more missing disease assessments, or lost to follow-up. Kaplan-Meier method was used.

    Measured: From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)

Secondary outcomes (16)

  1. Overall Survival (OS)-All Randomized Participants

    OS was defined as the time from date of randomization to date of death due to any cause. In case of no death, OS time would be censored on the date participant was last known to be alive.

    Measured: From date of randomization to the date of death due to any cause or censoring date

  2. OS-Participants With ESR1 Mutation

    OS was defined as the time from date of randomization to date of death due to any cause. In case of no death, OS time would be censored on the date participant was last known to be alive.

    Measured: From date of randomization to the date of death due to any cause or censoring date

  3. Percentage of Participants With Objective Response (OR) by BICR Assessment- Participants With Measurable Disease at Baseline

    OR was defined as the best overall response of confirmed complete response (CR) or partial response (PR) by BICR assessment as per RECIST v1.1 criteria. As per RECIST v1.1, CR was defined as complete disappearance of all target lesions, with the exception of nodal disease, complete disappearance of all non-target lesions and no new lesions. All nodes decreased to normal (short axis <10 mm); all target lesions and disease sites were assessed. PR was defined as at least a 30% decrease from baseline in the sum of diameters of all target lesions, non-PD/not evaluated for the non-target lesions and no new lesions. The short diameter was used in the sum for nodal target lesions, while the longest diameter was used in the sum for non-nodal target lesions, all target lesions were assessed.

    Measured: From randomization until PD, death or start of new anticancer therapy, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)

  4. Clinical Benefit Rate (CBR) by BICR Assessment

    CBR: percentage of participants with clinical benefit response. Clinical benefit response: confirmed CR or PR at any time, or stable disease (SD) >=24 weeks per RECIST v1.1. CR: complete disappearance of all target lesions, of all non-target lesions and no new lesions; except for nodal disease, all nodes decreased to normal (short axis <10 mm); all disease sites, all target lesions assessed. PR: >=30% decrease from baseline in sum of diameters of all target lesions, non-PD/not evaluated for non-target lesions and no new lesions; all target lesions assessed. SD: did not qualify for CR, PR, PD. All target lesions assessed. PD per RECIST v1.1: at least 20% increased sum of diameters of target measurable lesions above nadir (smallest sum observed considering baseline and all assessments prior to timepoint under evaluation), with minimum absolute increase of 5mm relative to nadir or unequivocal progression of existing non-target lesions, or new lesions.

    Measured: From randomization until PD, death due to any cause or start of new anticancer therapy, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)

  5. Duration of Response (DOR) by BICR Assessment

    DOR was defined as time from first documentation of objective tumor response (CR or PR) to first documentation of PD, or death due to any cause, whichever occurred first. CR: complete disappearance of all target lesions, of all non-target lesions and no new lesions; except for nodal disease, all nodes decreased to normal (short axis <10 mm); all disease sites, all target lesions assessed. PR: >=30% decrease from baseline in sum of diameters of all target lesions, non-PD/not evaluated for non-target lesions and no new lesions; all target lesions were assessed. The short diameter is used in the sum for nodal target lesions, while longest diameter is used in sum for non-nodal target lesions, all target lesions were assessed. DOR was analyzed in participants with an OR. PD: at least 20% increase in sum of diameters of target measurable lesions above nadir, with minimum absolute increase of 5 mm relative to nadir or unequivocal progression of existing non-target lesions, or new lesions.

    Measured: From first documentation of objective tumor response until confirmed PD or death, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)

  6. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs, Grade 3 or 4 and Grade 5 TEAEs as Assessed by NCI CTCAE v5.0

    Adverse event (AE): any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. AEs included both SAEs and all other (non-SAEs) AEs. SAE: any untoward medical occurrence, at any dose met one or more of following criteria: death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or other important medical events. TEAEs: AEs that occur on or after first dose of study treatment up to 28 days after last dose of study treatment. Relatedness to study drug were judged by investigator. As per National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) severity of AEs were graded as following, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening; urgent treatment indicated, Grade 5: death related to AE.

    Measured: From the first dose of study treatment up to 28 days after last dose of study treatment

  7. Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE v5.0

    Hematological parameters including neutrophil count decreased, white blood cell decreased, anemia, platelet count decreased, hemoglobin increased and leukocytosis were assessed. Baseline was defined as the last assessment on or prior to the date of the first dose of study treatment. As per NCI CTCAE v5.0, severity was graded as, Grade 1: mild, Grade 2: moderate, Grade 3: severe and Grade 4: life-threatening; urgent treatment indicated. Grade 0: Non-missing laboratory value that fell outside the grading range for the corresponding laboratory parameter. Categories with at least 1 non-zero values showing any shift in Grade from baseline to post-baseline were reported.

    Measured: From baseline up to 28 days after last dose of study treatment (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively)

  8. Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE v5.0

    Serum chemistry parameters including alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholesterol high, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia were assessed. Baseline was defined as the last assessment on or prior to the date of the first dose of study treatment. As per NCI CTCAE v5.0 severity was graded as, Grade 1: mild, Grade 2: moderate, Grade 3: severe and Grade 4: life-threatening; urgent treatment indicated. Grade 0: Non-missing laboratory value that falls outside the grading range for the corresponding laboratory parameter. Categories with at least 1 non-zero values showing any shift in Grade from baseline to post-baseline were reported.

    Measured: From baseline up to 28 days after last dose of study treatment (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively)

  9. Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters

    Twelve lead ECGs were collected using an automated ECG machine that calculated heart rate and measured corrected QT (QTc interval, QT interval, PR interval and QRS complex). Criteria for heart rate was as follows, <= 50 beats/minute (min), >=100 beats/min, increase from baseline >= 20 beats/min, decrease from baseline >= 20 beats/min. Criteria for PR interval was >= 220 millisecond (msec). Criteria for QRS interval was >= 120 msec. Criteria for QT interval was as follows, <=450 msec, > 450 to <= 480 msec, >480 to <=500 msec, >500 msec, increase from baseline <= 30 msec, increase from baseline > 30 to <= 60 msec. Criteria for QTCF interval was as follows, <=450 msec, > 450 to <= 480 msec, > 480 to <= 500 msec, > 500 msec, increase from baseline <= 30 msec, increase from baseline > 30 to <= 60 msec, increase from baseline > 60 msec. Baseline was defined as the last assessment on or prior to the date of the first dose of study treatment.

    Measured: From baseline up to 28 days after last dose of study treatment (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively)

  10. Number of Participants According to Categorization of QT Interval Corrected Using Fridericia's Formula (QTcF) Results-QTc Substudy Analysis Set

    Criteria for QTcF interval for single beat were as follows, <= 450 msec, > 450 to <= 480 msec, > 480 to <=500 msec, > 500 msec, increase from baseline <= 30 msec, increase from baseline > 30 to <= 60 msec, increase from baseline > 60 msec. Baseline was defined as the last assessment on or prior to the date of the first dose of study treatment.

    Measured: Baseline and from the first dose of study treatment up to the end of treatment (EOT) i.e., 28 days after last dose of study treatment (approximately up to 19.56 months)

  11. Change From Baseline in European Organization for the Research and Treatment of Cancer and Quality of Life Questionnaire (EORTC QLQ-C30) Score

    The EORTC QLQ-C30 contains 30 items and is composed of 5 multi-item functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning), 3 multi-item symptom scales (fatigue, pain and nausea/vomiting), 6 single item symptom scales (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and one global quality of life scale. This questionnaire contained 30 questions organized into 5 multi-item functional scales, 3 multi-item symptom scales, 6 single item symptom scales, and one global quality of life scale. All the scales and single-item measures range in score from 0 to 100. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms.

    Measured: From baseline up to 28 days after last dose of study treatment

  12. Change From Baseline in European Organization for the Research and Treatment of Cancer and Quality of Life Questionnaire-Breast Cancer Specific (EORTC QLQ-BR23) Score

    The EORTC QLQ-BR23 was a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consisted of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side-effects, breast symptoms, arm symptoms, upset by hair loss). Each item was rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much) within each scale. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning. For symptom-oriented scales, higher scores represented greater symptom severity.

    Measured: From baseline up to 28 days after last dose of study treatment

  13. Change From Baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Index and Visual Analogue Scale (VAS) Scores

    The EQ-5D-5L was a 5-item participant-completed questionnaire designed to assess health status in terms of a single index value or utility score. There were 2 components, a Health State Profile where participants rated their level of problems (1=none, 2=slight, 3=moderate, 4=severe, 5=extreme/unable) in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a visual analogue scale (VAS) in which participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). Responses to 5 dimensions comprised health state/ single utility index value. E.g. if a participant responds "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses) had a unique predefined utility index value assigned to it per US value sets, Overall index scores ranged from 0 to 1, with lower scores representing a higher level of dysfunction.

    Measured: From baseline up to 28 days after last dose of study treatment

  14. Change From Baseline in Pain Severity and Pain Interference as Assessed by Brief Pain Inventory Short Form (BPI-SF) Score

    The BPI-SF consisted of items to measure participant perceptions of pain severity (item 3), assess degree of interference of pain on daily functioning, body diagrams on which participants indicate location of pain, record pain medication usage, VAS assessed degree of pain relief in last 24 hours (item 9a). Items in pain severity scale evaluated pain "at its worst", "at its least", and "on average" over previous 24 hours, as well as "pain now" (at time of assessment). Participants responded on 10- point numerical rating scale, where 0 = "no pain" and 10 = "pain as bad as you can imagine". Pain interference scale asked participants to rate how their pain interferes with "enjoyment of life", "general activity", "walking ability", "mood", "sleep", "normal work" and "relations with other people." Responses for interference scale were also based on 10-points scale, where 0 = "does not interfere" and 10 = "interferes completely". Higher scores=high levels of pain, impact attributed to pain.

    Measured: From baseline up to 28 days after last dose of study treatment

  15. Plasma Concentration of ARV-471 and Its Epimer ARV-473

    Plasma concentrations of ARV-471 and its epimer ARV-473 were reported in this outcome measure.

    Measured: Anytime between -4 to 0 hours on Day 1 of Cycle 2, Cycle 3, Cycle 5 and Cycle 7 and anytime between 5 to 7 hours on Day 1 of Cycle 2 and Cycle 3

  16. Change in Plasma Circulating Tumor DNA (ctDNA) From Baseline

    Quantitative change in plasma ctDNA levels from baseline to each protocol specified time point (up to EOT), as assessed using a validated assay.

    Measured: Baseline and up to EOT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2022
  2. Study start3 Mar 2023
  3. Primary completion31 Jan 2025
  4. Study completion15 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
624 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05654623
Sponsor's protocol ID
C4891001
Other IDs
2022-500544-38-00
Acronym
VERITAC-2
Status last verified
Feb 2026
First submitted
16 Nov 2022
Last updated
18 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Campone M, De Laurentiis M, Jhaveri K, Hu X, Ladoire S, Patsouris A, Zamagni C, Cui J, Cazzaniga M, Cil T, Jerzak KJ, Fuentes C, Yoshinami T, Rodriguez-Lescure A, Sezer A, Fontana A, Guarneri V, Molckovsky A, Mouret-Reynier MA, Demirci U, Zhang Y, Valota O, Lu DR, Martignoni M, Parameswaran J, Zhi X, Hamilton EP; VERITAC-2 Study Group. Vepdegestrant, a PROTAC Estrogen Receptor Degrader, in Advanced Breast Cancer. N Engl J Med. 2025 Aug 7;393(6):556-568. doi: 10.1056/NEJMoa2505725. Epub 2025 May 31.

    PubMed 40454645

  • Hamilton EP, Ma C, De Laurentiis M, Iwata H, Hurvitz SA, Wander SA, Danso M, Lu DR, Perkins Smith J, Liu Y, Tran L, Anderson S, Campone M. VERITAC-2: a Phase III study of vepdegestrant, a PROTAC ER degrader, versus fulvestrant in ER+/HER2- advanced breast cancer. Future Oncol. 2024;20(32):2447-2455. doi: 10.1080/14796694.2024.2377530. Epub 2024 Jul 29.

    PubMed 39072356

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ARV-471 and Fulvestrant in people with Advanced Breast Cancer, run by Pfizer at 312 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 312 sites in United States, China, Spain, Japan, Brazil and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants (time frame: From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05654623, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in