A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer (VERITAC-2)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Drug: ARV-471; Drug: Fulvestrant

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.

• Study Type: Interventional
• Enrollment (Actual): 624
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Fundación Respirar
  • Buenos Aires, Argentina, 1426
    • Centro Oncologico Korben
  • Buenos Aires, Argentina, 1431
    • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
  • Córdoba, Argentina, X5004FHP
    • Clínica Universitaria Reina Fabiola
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, B1884BBF
      • Centro de Oncología e Investigación de Buenos Aires
    • CABA, Buenos Aires, Argentina, 1417
      • Instituto de Oncología Ángel H. Roffo
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1023AAB
      • Stat Research S.A.
  • Buenos Aires F.D.
    • CABA, Buenos Aires F.D., Argentina, 1125
      • Fundación Cenit para la Investigación en Neurociencias
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Fundacion Estudios Clinicos
    • Rosario, Santa Fe Province, Argentina, S2000ORE
      • Sanatorio de la Mujer
• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • Coffs Harbour Health Campus
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast University Private Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • ICON Cancer Centre - Kurralta Park
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Icon Cancer Centre Hobart
  • Victoria
    • Brighton, Victoria, Australia, 3186
      • Cabrini Hospital -Brighton
    • Geelong, Victoria, Australia, 3220
      • Barwon Health
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital - Malvern
• Austria
  • Salzburg, Austria, 5020
    • Uniklinikum Salzburg
  • Styria
    • Graz, Styria, Austria, 8036
      • Medizinische Universität Graz
• Belgium
  • Liège, Belgium, 4000
    • Clinical Chc Montlégia
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Antwerp University Hospital
  • Bruxelles-capitale, Région de
    • Woluwe-Saint-Lambert, Bruxelles-capitale, Région de, Belgium, 1200
      • Cliniques Universitaires Saint-Luc
  • Hainaut
    • Gilly, Hainaut, Belgium, 6060
      • Grand Hopital De Charleroi
  • Vlaams-brabant
    • Leuven, Vlaams-brabant, Belgium, 3000
      • UZ Leuven
• Brazil
  • São Paulo, Brazil, 04014-002
    • IBCC - Núcleo de Pesquisa e Ensino
  • São Paulo, Brazil, 03102002
    • IBCC - Instituto Brasileiro de Controle do Cancer
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29043-260
      • Hospital Santa Rita de Cassia
  • Rio Grande do Sul
    • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital São Lucas da PUCRS
    • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
      • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
    • Porto Alegre, Rio Grande do Sul, Brazil, 90880-480
      • Hospital Mae de Deus
    • Porto Alegre, Rio Grande do Sul, Brazil, 90560032
      • Hospital Moinhos de Vento
    • Porto Alegre, Rio Grande do Sul, Brazil, 90850-170
      • Centro de Pesquisa Clínica - Área Administrativa
  • Santa Catarina
    • Lages, Santa Catarina, Brazil, 88501001
      • ANIMI - Unidade de Tratamento Oncologico
  • São Paulo
    • Santo André, São Paulo, Brazil, 09060-650
      • Faculdade de Medicina do ABC
    • São Paulo, São Paulo, Brazil, 01509-010
      • A. C. Camargo Cancer Center
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Complex Oncology Center - Burgas
  • Plovdiv, Bulgaria, 4004
    • Complex Oncology Center - Plovdiv EOOD
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • BC Cancer Surrey
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • The Moncton Hospital
  • Ontario
    • Kitchener, Ontario, Canada, N2G 1G3
      • Waterloo Regional Health Network
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
    • Toronto, Ontario, Canada, M5B 1W8
      • Unity Health Toronto, St. Michael's Hospital
  • Quebec
    • Saint-Jérôme, Quebec, Canada, J7Y 0L1
      • Centre de Services Ambulatoires de St-Jerome
    • Saint-Jérôme, Quebec, Canada, J7Z 2V4
      • Unite de Recherche Clinique Du Cisss Des Laurentides
• China
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
    • Hefei, Anhui, China, 230031
      • Anhui Provincial Cancer Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Cancer Hospital Chinese Academy of Medical Science
    • Beijing, Beijing Municipality, China, 100005
      • Beijing Hospital
  • Fujian
    • Fuzhou Fujian, Fujian, China, 350001
      • Fujian Medical University Union Hospital
  • Guangdong
    • Foshan, Guangdong, China, 528041
      • The First People's Hospital of Foshan
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China, 510555
      • Sun Yat-sen University Cancer Center
  • Guangxi
    • Nanning, Guangxi, China, 530201
      • Guangxi Medical University Affiliated Tumor Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Luoyang, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science &Technology
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital Cancer Center
    • Wuhan, Hubei, China, 430040
      • Jinyinhu Branch of Tongji Medical College Affiliated Union Hospital, Huazhong University of Science
  • Jiangsu
    • Nanjing, Jiangsu, China, 210031
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330009
      • Nanchang People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116023
      • The 2nd Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital Shanghai Jiaotong University School of Medicine
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute & Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650106
      • Yunnan Province Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310052
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
• Czechia
  • Prague, Czechia, 10034
    • Fakultní Nemocnice Královské Vinohrady
  • Brno-město
    • Brno, Brno-město, Czechia, 625 00
      • Fakultní nemocnice Brno Bohunice
  • Praha 4
    • Prague, Praha 4, Czechia, 14059
      • Fakultni Thomayerova nemocnice
• Finland
  • Pori, Finland, 28500
    • Satakunnan Keskussairaala
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Tampereen yliopistollinen sairaala
  • Pohjanmaa
    • Vaasa, Pohjanmaa, Finland, 65130
      • Vaasan Keskussairaala
• France
  • Côte-d'or
    • Dijon, Côte-d'or, France, 21079
      • Centre Georges François Leclerc
  • Languedoc-roussillon
    • Montpellier, Languedoc-roussillon, France, 34070
      • Centre de Cancerologie du Grand Montpellier
  • Loire-atlantique
    • Saint-Herblain, Loire-atlantique, France, 44805
      • Institut de Cancérologie de l'Ouest
  • Maine-et-loire
    • Angers, Maine-et-loire, France, 49055
      • Institut de Cancérologie de l'Ouest
  • Puy-de-dôme
    • Clermont-Ferrand, Puy-de-dôme, France, 63011
      • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
  • Vaucluse
    • Avignon, Vaucluse, France, 84918
      • Sainte Catherine Institut du Cancer Avignon Provence
  • Vienne
    • Poitiers, Vienne, France, 86021
      • Centre Hospitalier Universitaire De Poitiers
  • Île-de-France Region
    • Créteil, Île-de-France Region, France, 94000
      • Henri Mondor Hospital
• Germany
  • Berlin, Germany, 10707
    • Onkologische Schwerpunktpraxis Kurfuerstendamm
• Greece
  • Achaḯa
    • Pátrai, Achaḯa, Greece, 26504
      • University Hospital of Patras
  • Attikí
    • Athens, Attikí, Greece, 115 28
      • Alexandra General Hospital of Athens
    • Chaidari/Athens, Attikí, Greece, 12462
      • Attikon General University Hospital
  • Irakleío
    • Heraklion, Irakleío, Greece, 715 00
      • University General Hospital of Heraklion
  • Thessalía
    • Larissa, Thessalía, Greece, 41110
      • University General Hospital of Larissa
• Hungary
  • Budapest, Hungary, 1145
    • Budapesti Uzsoki Utcai Korhaz
  • Győr-Moson-Sopron
    • Győr, Győr-Moson-Sopron, Hungary, 9024
      • Petz Aladar Egyetemi Oktato Korhaz
• India
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Artemis hospital
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Tata Memorial hospital
    • Nashik, Maharashtra, India, 422002
      • HCG Manavata Cancer Centre
    • Nashik, Maharashtra, India, 422009
      • Apex Wellness Hospital
    • Thane, Maharashtra, India, 401107
      • Bhakti Vedanta Hospital and Research Institute
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110085
      • Rajiv Gandhi Cancer Institute And Research Centre
    • New Delhi, National Capital Territory of Delhi, India, 110075
      • Venkateshwar Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
• Israel
  • Central District
    • Petah Tikva, Central District, Israel, 4941492
      • Rabin Medical Center
    • Rehovot, Central District, Israel, 7610001
      • Kaplan Medical Center
• Italy
  • Macerata, Italy, 62100
    • Ospedale Generale Provinciale Macerata
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia IRCCS
  • Padua, Italy, 35128
    • Istituto Oncologico Veneto IRCCS
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Catania
    • Misterbianco, Catania, Italy, 95045
      • Humanitas Istituto Clinico Catanese
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • Azienda Ospedaliero Universitaria Di Ferrara
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
  • Lombardy
    • Monza, Lombardy, Italy, 20900
      • Fondazione IRCCS San Gerardo dei Tintori
  • The Marches
    • Ancona, The Marches, Italy, 60126
      • Azienda Ospedaliero Universitaria delle Marche
  • Tuscany
    • Pisa, Tuscany, Italy, 56126
      • Azienda Ospedaliero Universitaria Pisana
• Japan
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Kagoshima, Japan, 892-0833
    • Sagara Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 466-8560
      • Nagoya University Hospital
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Nagoya City University Hospital
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center Hospital
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Chiba Cancer Center
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 2418515
      • Kanagawa Cancer Center
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Saitama
    • Ina-machi, Saitama, Japan, 362-0806
      • Saitama Prefectural Cancer Center
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Bunkyo-ku, Tokyo, Japan, 113-8677
      • Tokyo Metropolitan Komagome Hospital, Department of Breast Surgery
    • Koto, Tokyo, Japan, 135-8550
      • Japanese Foundation for Cancer Research
    • Koto-ku, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital of JFCR
    • Shinjuku, Tokyo, Japan, 162-8655
      • National Center for Global Health and Medicine
    • Shinjuku-ku, Tokyo, Japan, 162-8655
      • Center Hospital of the National Center for Global Health and Medicine
• Mexico
  • Oaxaca City, Mexico, 68020
    • Centro de Investigacion Clinica de Oaxaca
  • Jalisco
    • Guadajalara, Jalisco, Mexico, 44600
      • Boca Clinical Trials Mexico S.C.
  • Mexico City
    • Cuauhtémoc, Mexico City, Mexico, 06100
      • Cryptex Investigación Clínica S.A. de C.V.
• Poland
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-348
      • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
    • Krakow, Lesser Poland Voivodeship, Poland, 31-501
      • SP ZOZ Szpital Uniwersytecki w Krakowie
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-219
      • COPERNICUS PL, Wojewodzkie Centrum Onkologii
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-338
      • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials, LLC
  • Rio Piedras, Puerto Rico, 00935
    • Hospital Oncologico Dr. Isaac Gonzalez-Martinez
  • San Juan, Puerto Rico, 00927
    • FDI Clinical Research
  • Puerto RICO
    • Hato Rey, Puerto RICO, Puerto Rico, 00917
      • Puerto Rico Medical Research Center
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny Onkologicky Ustav
  • Bratislava, Slovakia, 812 50
    • Onkologicky ustav sv. Alzbety, s.r.o.
  • Košice, Slovakia, 04191
    • Vychodoslovensky onkologicky ustav, a.s.
  • Partizánske, Slovakia, 95801
    • Nemocnica na okraji mesta n o
  • Trnava, Slovakia, 917 75
    • Fakultna nemocnica Trnava
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Iatros International
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research
    • Johannesburg, Gauteng, South Africa, 2193
      • Charlotte Maxeke Johannesburg Academic Hospital
    • Johannesburg, Gauteng, South Africa, 2193
      • WCR Office
• South Korea
  • Incheon-gwangyeoksi [incheon]
    • Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea, 21565
      • Gachon University Gil Medical Center
  • Kyǒnggi-do
    • Goyang-si, Kyǒnggi-do, South Korea, 10408
      • National Cancer Center
    • Seongnam, Kyǒnggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
    • Suwon, Kyǒnggi-do, South Korea, 16499
      • Ajou University Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 05505
      • Asan Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06273
      • Gangnam Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06591
      • The Catholic Univ. of Korea Seoul St. Mary's Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 02841
      • Korea University Anam Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea
      • Ewha Womans University MokDong Hospital
• Spain
  • Granada, Spain, 18016
    • Hospital Universitario San Cecilio
  • Granada, Spain, 18012
    • Hospital Universitario Virgen Nieves
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro
  • Manresa, Spain, 8423
    • Althaia, xarxa assistencial universitaria de Manresa
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • A Coruña [LA Coruña]
    • A Coruña, A Coruña [LA Coruña], Spain, 15006
      • CHUAC-Hospital Teresa Herrera
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche
  • Barcelona [barcelona]
    • Badalona, Barcelona [barcelona], Spain, 08916
      • Institut Català d'Oncologia (ICO) - Badalona
    • Barcelona, Barcelona [barcelona], Spain, 08035
      • Hospital Universitari Vall d'Hebron
    • Barcelona, Barcelona [barcelona], Spain, 08003
      • Parc de Salut Mar - Hospital del Mar
  • Basque Country
    • Bilbao, Basque Country, Spain, 48013
      • Osi Bilbao-Basurto
  • Catalunya [cataluña]
    • L'Hospitalet de Llobregat, Catalunya [cataluña], Spain, 08908
      • Institut Catala d'Oncologia - L'Hospitalet
  • Gipuzkoa
    • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
      • Hospital Universitario Donostia
  • Lleida [lérida]
    • Lleida, Lleida [lérida], Spain, 25198
      • Hospital Universitario Arnau de Vilanova de Lleida
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28041
      • Hospital Universitario 12 de octubre
  • Málaga
    • Málaga, Málaga, Spain, 29010
      • Hospital Universitario Virgen de la Victoria
  • Tarragona [tarragona]
    • Reus, Tarragona [tarragona], Spain, 43204
      • Salut Sant Joan de Reus-Baix Camp (Edp)
• Sweden
  • Stockholms LÄN [se-01]
    • Stockholm, Stockholms LÄN [se-01], Sweden, 11883
      • Södersjukhuset
• Switzerland
  • Canton of Aargau
    • Aarau, Canton of Aargau, Switzerland, 5000
      • Tumor Zentrum Aarau
  • Thurgau
    • Frauenfeld, Thurgau, Switzerland, 8500
      • Kantonsspital Frauenfeld - Spital Thurgau AG
    • Münsterlingen, Thurgau, Switzerland, CH8596
      • Kantonsspital Münsterlingen - Spital Thurgau AG
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei, Taiwan, 116
    • Taipei Municipal Wan Fang Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
  • Kaohsiung
    • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
      • Chang Gung Memorial Hospital at Kaohsiung
  • Tainan
    • Tainan, Tainan, Taiwan, 73657
      • Chi Mei Hospital - Liouying Branch
    • Tainan, Tainan, Taiwan, 71004
      • Chi Mei Medical Center
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01140
    • Adana Medical Park Seyhan Hastanesi
  • Adana, Turkey (Türkiye), 01370
    • Adana Sehir Egitim ve Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06010
    • Gulhane Egitim Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Sehir Hastanesi
  • Antalya, Turkey (Türkiye), 07059
    • Akdeniz Universitesi Hastanesi
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University Medical Faculty Hospital
  • Samsun, Turkey (Türkiye), 55200
    • Samsun Medical Park Hastanesi
  • Ankara
    • Altindağ, Ankara, Turkey (Türkiye), 06230
      • Hacettepe Universite Hastaneleri
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34722
      • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34752
      • Acibadem Altunizade Hospital
  • İ̇zmir
    • Izmir, İ̇zmir, Turkey (Türkiye), 35575
      • I.E.U. Medical Point Hastanesi
• United Kingdom
  • Blackburn, United Kingdom, BB2 3HH
    • Royal Blackburn Hospital
  • Glasgow, United Kingdom, G12 0YN
    • The Beatson West of Scotland Cancer Centre
  • Manchester, United Kingdom, M20 4GJ
    • The Christie Hospital NHS Foundation Trust
  • London, CITY of
    • London, London, CITY of, United Kingdom, EC1A 7BE
      • St Bartholomew'S Hospital
• United States
  • California
    • Encinitas, California, United States, 92024
      • California Cancer Associates for Research and Excellence, Inc. (cCARE)
    • Fountain Valley, California, United States, 92708
      • Orange Coast Memorial Medical Center
    • Fresno, California, United States, 93720
      • California Cancer Associates for Research and Excellence
    • Napa, California, United States, 94558
      • Providence Queen of the Valley Medical Center
    • San Marcos, California, United States, 92069
      • California Cancer Associates for Research and Excellence
    • Sylmar, California, United States, 91342
      • Olive View-UCLA Medical Center
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Smilow Cancer Hospital Care center at Fairfield
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital at Yale-New Haven
    • North Haven, Connecticut, United States, 06473
      • Smilow Cancer Hospital Care center at North Haven
    • Trumbull, Connecticut, United States, 06611
      • Smilow Cancer Hospital Care Center at Trumbull
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Florida Cancer Specialists
    • Bonita Springs, Florida, United States, 34135
      • Florida Cancer Specialists BON
    • Bradenton, Florida, United States, 34205
      • Florida Cancer Specialists BCC
    • Bradenton, Florida, United States, 34211
      • Florida Cancer Specialists LRS
    • Brandon, Florida, United States, 33511
      • Florida Cancer Specialists
    • Cape Coral, Florida, United States, 33909
      • Florida Cancer Specialists NFM
    • Clearwater, Florida, United States, 33761
      • Florida Cancer Specialists
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital - Baycare Health System
    • Daytona Beach, Florida, United States, 32117
      • Florida Cancer Specialists
    • Fort Myers, Florida, United States, 33905
      • Florida Cancer Specialists COL
    • Fort Myers, Florida, United States, 33908
      • Florida Cancer Specialists GLO
    • Gainesville, Florida, United States, 32605
      • Florida Cancer Specialists
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Cancer Center
    • Largo, Florida, United States, 33770
      • Florida Cancer Specialists
    • Lecanto, Florida, United States, 34461
      • Florida Cancer Specialists
    • N. Venice, Florida, United States, 34275
      • Florida Cancer Specialist And Research Institute
    • Naples, Florida, United States, 34102
      • Florida Cancer Specialists NGD
    • North Port, Florida, United States, 34286
      • Florida Cnacer Specialists
    • Ocala, Florida, United States, 34474
      • Florida Cancer Specialists
    • Orange City, Florida, United States, 32763
      • Florida Cancer Specialists
    • Orlando, Florida, United States, 32806
      • Florida Cancer Specialists
    • Port Charlotte, Florida, United States, 33980
      • Florida Cancer Specialists PCH
    • Sarasota, Florida, United States, 34232
      • Florida Cancer Specialists SAC
    • Sarasota, Florida, United States, 34236
      • Florida Cancer Specialists SAD
    • St. Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists
    • Stuart, Florida, United States, 34994
      • Florida Cancer Specialists
    • Tampa, Florida, United States, 33607
      • Florida Cancer Specialists
    • Tavares, Florida, United States, 32778
      • Florida Cancer Specialists
    • The Villages, Florida, United States, 32159
      • Florida Cancer Specialists
    • Trinity, Florida, United States, 34655
      • Florida Cancer Specialist
    • Vero Beach, Florida, United States, 32960
      • Florida Cancer Specialists
    • Wellington, Florida, United States, 33414
      • Florida Cancer Specialists
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
    • Winter Park, Florida, United States, 32789
      • Florida Cancer Specialists
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Hope and Healing Cancer Services
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Hospital
    • Louisville, Kentucky, United States, 40241
      • Norton Brownsboro Hospital
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute, St Matthews Campus
    • Louisville, Kentucky, United States, 40241
      • Norton Cancer Institute, Brownsboro Hospital Campus
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute, Downtown
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute - Downtown
    • Louisville, Kentucky, United States, 40207
      • Norton Women's & Children's Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans
    • Shreveport, Louisiana, United States, 71103
      • Louisiana State University Health Sciences Shreveport
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic Hematology/Oncology
  • Missouri
    • Ballwin, Missouri, United States, 63011
      • Mercy Clinic Oncology and Hematology
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Cancer Institute
    • St Louis, Missouri, United States, 63141
      • Mercy Research - David C. Pratt Cancer Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • MSK Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • MSK Monmouth
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering - Bergen
  • New York
    • Camillus, New York, United States, 13031
      • Hematology Oncology Associates of CNY
    • Commack, New York, United States, 11725
      • MSK Commack
    • East Syracuse, New York, United States, 13057
      • Hematology-Oncology Associates of Central New York, PC
    • Harrison, New York, United States, 10604
      • MSK Westchester
    • Lake Success, New York, United States, 11042
      • R.J. Zuckerberg Cancer Center
    • Mount Kisco, New York, United States, 10549
      • Northern Westchester Hospital
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • MSK Evelyn H. Lauder Breast and Imaging Center
    • Nyack, New York, United States, 10960
      • Hematology Oncology Associates of Rockland
    • Sleepy Hollow, New York, United States, 10591
      • Phelps Hospital
    • Uniondale, New York, United States, 11553
      • MSK Nassau
  • Oklahoma
    • Lawton, Oklahoma, United States, 73505
      • Cancer Centers of Southwest Oklahoma
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Cancer Institute Franz Clinic
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Cancer Center
    • Charlottesville, Virginia, United States, 22911
      • UVA Breast Care Center
    • Mechanicsville, Virginia, United States, 23116
      • Bon Secours Memorial Regional Medical Center
    • Midlothian, Virginia, United States, 23114
      • Bon Secours St. Francis Medical Center
    • Richmond, Virginia, United States, 23226
      • Bon Secours St. Mary's Hospital
  • Washington
    • Aberdeen, Washington, United States, 98520
      • Providence Regional Cancer System - Aberdeen
    • Centralia, Washington, United States, 98531
      • Providence Regional Cancer System- Centralia
    • Lacey, Washington, United States, 98503
      • Providence Regional Cancer System - Lacey
    • Renton, Washington, United States, 98055
      • UW Medicine Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARV-471	Drug: ARV-471; orally, once daily on a 28-day continuous dosing schedule; Other Names: PF-07850327
Active Comparator: Fulvestrant	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of randomization to the date of death due to any cause or censoring date
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.	From date of randomization to the date of death due to any cause or censoring date
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	From baseline up to 28 days after last dose of study treatment
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.	From baseline up to 28 days after last dose of study treatment
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.	From baseline up to 28 days after last dose of study treatment
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.	From baseline up to 28 days after last dose of study treatment
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.	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
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.	Baseline and up to EOT
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.	From the first dose of study treatment up to 28 days after last dose of study treatment

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Arvinas Estrogen Receptor, Inc.
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General 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.
• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Actual): January 31, 2025
• Study Completion (Estimated): May 15, 2028

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Breast cancer; Metastatic breast cancer; HR+; Estrogen receptor positive; Fulvestrant; PROTAC; Hormone Therapy; Recurrent breast cancer; Breast neoplasm; HER2-negative; Endocrine therapy; Breast tumor; ER(+)/HER2(-) Advanced Breast Cancer; Advanced cancer of the breast; ER degrader; Vepdegestrant; Hormone positive breast cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Fulvestrant
• Other Study ID Numbers: C4891001; 2022-500544-38-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No