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

February 13, 2024 updated by: Pfizer

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Not yet recruiting
        • Fundación Respirar
      • Buenos Aires, Argentina, 1426
        • Recruiting
        • Centro Oncologico Korben
    • Ciudad Autónoma DE Buenos Aires
      • Caba, Ciudad Autónoma DE Buenos Aires, Argentina, 1125
        • Recruiting
        • Fundacion CENIT para la Investigacion en Neurociencias
    • Santa FE
      • Rosario, Santa FE, Argentina, S2000ORE
        • Recruiting
        • Sanatorio de la Mujer
  • Australia
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast University Private Hospital
      • Birtinya, Queensland, Australia, 4575
        • Not yet recruiting
        • Sunshine Coast University Private Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Icon Cancer Centre Hobart
    • Victoria
      • Brighton, Victoria, Australia, 3186
        • Recruiting
        • Cabrini Hospital -Brighton
      • Geelong, Victoria, Australia, 3220
        • Recruiting
        • Barwon Health
      • Malvern, Victoria, Australia, 3144
        • Recruiting
        • Cabrini Hospital - Malvern
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Not yet recruiting
        • Antwerp University Hospital
    • Bruxelles-capitale, Région DE
      • Woluwe-Saint-Lambert, Bruxelles-capitale, Région DE, Belgium, 1200
        • Not yet recruiting
        • Cliniques Universitaires Saint-Luc
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Not yet recruiting
        • Grand Hôpital de Charleroi
    • Vlaams-brabant
      • Leuven, Vlaams-brabant, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
  • Brazil
      • São Paulo, Brazil, 03102002
        • Recruiting
        • IBCC - Instituto Brasileiro de Controle do Cancer
      • São Paulo, Brazil, 04014-002
        • Recruiting
        • IBCC - Núcleo de Pesquisa e Ensino
    • Espírito Santo
      • Vitoria, Espírito Santo, Brazil, 29041-295
        • Recruiting
        • Hospital Santa Rita de Cassia
    • RIO Grande DO SUL
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Recruiting
        • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90110-270
        • Recruiting
        • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90880-480
        • Recruiting
        • Hospital Mae de Deus
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90850-170
        • Recruiting
        • Centro de Pesquisa Clínica - Área Administrativa
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-001
        • Not yet recruiting
        • Hospital Moinhos de Vento
    • SÃO Paulo
      • Santo André, SÃO Paulo, Brazil, 09060-650
        • Recruiting
        • Faculdade de Medicina do ABC
      • Sao Paulo, SÃO Paulo, Brazil, 01509-010
        • Recruiting
        • A. C. Camargo Cancer Center
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Recruiting
        • Complex Oncology Center - Burgas
      • Gabrovo, Bulgaria, 5300
        • Recruiting
        • Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
      • Haskovo, Bulgaria, 6300
        • Recruiting
        • Specialized Hospital for Active Treatment of Oncology - Haskovo
      • Plovdiv, Bulgaria, 4004
        • Recruiting
        • Complex Oncology Center - Plovdiv EOOD
      • Ruse, Bulgaria, 7002
        • Recruiting
        • Complex Oncology Center - Ruse EOOD
      • Vratsa, Bulgaria, 3000
        • Recruiting
        • Complex Oncology Center - Vratsa
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Not yet recruiting
        • Cross Cancer Institute
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Not yet recruiting
        • BC Cancer Surrey
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • The Moncton Hospital
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Recruiting
        • Grand River Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute
      • Toronto, Ontario, Canada, M4N 3M5
        • Not yet recruiting
        • Sunnybrook Research Institute
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • Unity Health Toronto, St. Michael's Hospital
    • Quebec
      • St-Jerome, Quebec, Canada, J7Z 5T3
        • Recruiting
        • Unité de Recherche Clinique du CISSS des Laurentides
      • St-Jerome, Quebec, Canada, J7Z 2V4
        • Recruiting
        • Unité de Recherche Clinique du CISSS des Laurentides
  • China
      • Zhengzhou, China, 450008
        • Recruiting
        • Henan Cancer Hospital
    • Anhui
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • Anhui Provincial Hospital
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Provincial Cancer Hospital
    • Fujian
      • Fuzhou Fujian, Fujian, China, 350001
        • Not yet recruiting
        • Fujian Medical University Union Hospital-1 Bingfanglou
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun yat-sen university cancer center
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital Cancer Center
    • Jiangsu
      • Nanjing, Jiangsu, China, 210031
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130021
        • Not yet recruiting
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, China, 710004
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Shaanxi/china
      • Xi'an, Shaanxi/china, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai, China, 200025
        • Not yet recruiting
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
    • Yunnan
      • Kunming, Yunnan, China, 650106
        • Not yet recruiting
        • Yunnan Province Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310052
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Fakultní Nemocnice Olomouc
      • Praha 10, Czechia, 10034
        • Recruiting
        • Fakultní nemocnice Královské Vinohrady
    • Brno-město
      • Brno, Brno-město, Czechia, 625 00
        • Recruiting
        • Fakultní nemocnice Brno Bohunice
    • Praha 4
      • Prague, Praha 4, Czechia, 14059
        • Recruiting
        • Fakultni Thomayerova nemocnice
    • Praha 8
      • Prague, Praha 8, Czechia, 180 81
        • Recruiting
        • Fakultni nemocnice Bulovka
  • Finland
      • Pori, Finland, 28500
        • Not yet recruiting
        • Satakunnan Keskussairaala
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Not yet recruiting
        • Tampereen yliopistollinen sairaala
    • Pohjanmaa
      • Vaasa, Pohjanmaa, Finland, 65130
        • Not yet recruiting
        • Vaasan Keskussairaala
    • Pohjois-pohjanmaa
      • Oulu, Pohjois-pohjanmaa, Finland, 90220
        • Not yet recruiting
        • Oulun yliopistollinen sairaala
  • France
    • Côte-d'or
      • Dijon, Côte-d'or, France, 21079
        • Recruiting
        • Centre Georges François Leclerc
    • Loire-atlantique
      • Saint Herblain, Loire-atlantique, France, 44805
        • Recruiting
        • Institut de Cancérologie de l'Ouest
    • Maine-et-loire
      • ANGERS cedex 02, Maine-et-loire, France, 49055
        • Recruiting
        • Institut de Cancérologie de l'Ouest
    • Puy-de-dôme
      • Clermont-Ferrand, Puy-de-dôme, France, 63011
        • Recruiting
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
    • Île-de-france
      • Créteil, Île-de-france, France, 94000
        • Recruiting
        • Henri Mondor Hospital
  • Germany
      • Berlin, Germany, 10707
        • Recruiting
        • Onkologische Schwerpunktpraxis Kurfuerstendamm
    • Baden-württemberg
      • Freiburg, Baden-württemberg, Germany, 79106
        • Not yet recruiting
        • Universitaetsklinikum Freiburg
    • Mecklenburg-vorpommern
      • Stralsund, Mecklenburg-vorpommern, Germany, 18439
        • Recruiting
        • Gynäkologie Kompetenzzentrum Stralsund
  • Greece
    • Achaḯa
      • Patras, Achaḯa, Greece, 26504
        • Recruiting
        • University Hospital of Patras
    • Attikí
      • Athens, Attikí, Greece, 115 28
        • Recruiting
        • Alexandra General Hospital of Athens
      • Chaidari/Athens, Attikí, Greece, 12462
        • Not yet recruiting
        • Attikon General University Hospital
    • Irakleío
      • Heraklion, Irakleío, Greece, 715 00
        • Not yet recruiting
        • University General Hospital of Heraklion
    • Thessalía
      • Larissa, Thessalía, Greece, 41110
        • Recruiting
        • University General Hospital of Larissa
  • Hungary
      • Budapest, Hungary, 1145
        • Not yet recruiting
        • Budapesti Uzsoki Utcai Korhaz
  • India
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • Recruiting
        • City Cancer Centre - Vijayawada
      • Vijayawada, Andhra Pradesh, India, 520002
        • Recruiting
        • Hcg Pet Imaging Centre
    • Delhi
      • New Delhi, Delhi, India, 110085
        • Recruiting
        • Rajiv Gandhi Cancer Institute and Research Centre
      • New Delhi, Delhi, India, 110029
        • Not yet recruiting
        • All India Institute of Medical Sciences
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Recruiting
        • Artemis Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Not yet recruiting
        • Tata Memorial Hospital
      • Nashik, Maharashtra, India, 422002
        • Recruiting
        • HCG Manavata Cancer Centre
      • Pune, Maharashtra, India, 411028
        • Not yet recruiting
        • Sahyadri Super Speciality Hospital, Hadapsar
      • Thane, Maharashtra, India, 401107
        • Recruiting
        • Bhakti Vedanta Hospital and Research Institute
    • WEST Bengal
      • Kolkata, WEST Bengal, India, 700020
        • Recruiting
        • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
  • Israel
    • Hamerkaz
      • Petah Tikva, Hamerkaz, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
      • Rehovot, Hamerkaz, Israel, 7610001
        • Recruiting
        • Kaplan Medical Center
      • Zerifin, Hamerkaz, Israel, 70300
        • Recruiting
        • Yitzhak Shamir Medical Center
  • Italy
      • Macerata, Italy, 62100
        • Recruiting
        • Ospedale Generale Provinciale Macerata
      • Milano, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia IRCCS
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS
    • Campania
      • Napoli, Campania, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
    • Catania
      • Misterbianco, Catania, Italy, 95045
        • Recruiting
        • Humanitas Istituto Clinico Catanese
    • Emilia-romagna
      • Bologna, Emilia-romagna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuor
    • Lombardia
      • Monza, Lombardia, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
    • Marche
      • Ancona, Marche, Italy, 60126
        • Recruiting
        • Azienda Ospedaliero Universitaria delle Marche
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
  • Japan
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center
      • Kagoshima, Japan, 892-0833
        • Recruiting
        • Sagara Hospital
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
      • Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Recruiting
        • Nagoya University Hospital
      • Nagoya, Aichi, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital
      • Nagoya, Aichi, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8717
        • Recruiting
        • Chiba Cancer Center
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Recruiting
        • National Hospital Organization Hokkaido Cancer Center
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 2418515
        • Recruiting
        • Kanagawa Cancer Center
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • Osaka University Hospital
    • Saitama
      • Ina-machi, Saitama, Japan, 362-0806
        • Recruiting
        • Saitama Prefectural Cancer Center
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
      • Bunkyo-ku, Tokyo, Japan, 113-8677
        • Recruiting
        • Tokyo Metropolitan Komagome Hospital, Department of Breast Surgery
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research
      • Koto-ku, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR
      • Shinjuku City, Tokyo, Japan, 162-8655
        • Recruiting
        • National Center for Global Health and Medicine
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • Recruiting
        • Center Hospital of the National Center for Global Health and Medicine
      • Shinjyuku-ku, Tokyo, Japan, 162-8655
        • Recruiting
        • Center Hospital of the National Center for Global Health and Medicine
  • Korea, Republic of
    • Incheon-gwangyeoksi [incheon]
      • Namdong-gu, Incheon-gwangyeoksi [incheon], Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center
    • Kyǒnggi-do
      • Goyang-si, Kyǒnggi-do, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
      • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
      • Suwon, Kyǒnggi-do, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 06591
        • Recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
        • Recruiting
        • Ewha Womans University MokDong Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 06273
        • Recruiting
        • Gangnam Severance Hospital, Yonsei University Health System
  • Norway
    • Akershus
      • Lorenskog, Akershus, Norway, 1474
        • Not yet recruiting
        • Akershus universitetssykehus
    • Buskerud
      • Drammen, Buskerud, Norway, 3004
        • Not yet recruiting
        • Drammen Sykehus, Vestre Viken HF
  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Not yet recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
    • Małopolskie
      • Kraków, Małopolskie, Poland, 30-348
        • Recruiting
        • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-704
        • Recruiting
        • KLIMED Marek Klimkiewicz
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-219
        • Recruiting
        • COPERNICUS PL, Wojewodzkie Centrum Onkologii
    • Łódzkie
      • Lodz, Łódzkie, Poland, 90-338
        • Recruiting
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00917
        • Recruiting
        • Puerto Rico Medical Research Center
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials, LLC
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials- Hospital Oncologico
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • FDI Clinical Research
      • San Juan, Puerto Rico, 00917
        • Not yet recruiting
        • Auxilio Mutuo Cancer Center
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • Recruiting
        • Narodny onkologicky ustav
      • Bratislava, Slovakia, 812 50
        • Recruiting
        • Onkologicky ustav sv. Alzbety, s.r.o.
      • Kosice, Slovakia, 04191
        • Recruiting
        • Vychodoslovensky onkologicky ustav, a.s.
      • Michalovce, Slovakia, 07101
        • Recruiting
        • Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
      • Partizanske, Slovakia, 95801
        • Recruiting
        • Nemocnica na okraji mesta n o
      • Presov, Slovakia, 080 01
        • Recruiting
        • Fakultna nemocnica s poliklinikou J.A. Reimana Presov
      • Trnava, Slovakia, 917 75
        • Recruiting
        • Fakultna nemocnica Trnava
      • Trnava, Slovakia, 917 17
        • Recruiting
        • Fakultna nemocnica Trnava
  • South Africa
    • FREE State
      • Bloemfontein, FREE State, South Africa, 9301
        • Recruiting
        • Iatros International
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • 15 Eton Road
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • Charlotte Maxeke Johannesburg Academic Hospital
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • WCR Office
      • Johannesburg, Gauteng, South Africa, 2196
        • Recruiting
        • Medical Oncology Centre of Rosebank
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • Wits Clinical Research
    • Western CAPE
      • Cape Town, Western CAPE, South Africa, 7700
        • Recruiting
        • Cancercare Rondebosch Oncology
  • Spain
      • Granada, Spain, 18012
        • Recruiting
        • Hospital Universitario Virgen Nieves
      • Granada, Spain, 18012
        • Recruiting
        • Hospital Unviersitario Virgen Nieves
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28050
        • Not yet recruiting
        • Hospital Universitario HM Sanchinarro
      • Manresa, Spain, 8423
        • Recruiting
        • ALTHAIA, Xarxa Assistencial Universitària de Manresa
    • A Coruña [LA Coruña]
      • A Coruña, A Coruña [LA Coruña], Spain, 15006
        • Recruiting
        • CHUAC-Hospital Teresa Herrera
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
    • Barcelona [barcelona]
      • Badalona, Barcelona [barcelona], Spain, 08916
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Badalona
      • Barcelona, Barcelona [barcelona], Spain, 08003
        • Recruiting
        • Parc de Salut Mar - Hospital del Mar
    • Catalunya [cataluña]
      • L'Hospitalet de Llobregat, Catalunya [cataluña], Spain, 08908
        • Recruiting
        • Institut Catala d'Oncologia - L'Hospitalet
    • Gipuzkoa
      • San Sebastian, Gipuzkoa, Spain, 20014
        • Recruiting
        • Hospital Universitario Donostia
    • Lleida [lérida]
      • Lleida, Lleida [lérida], Spain, 25198
        • Recruiting
        • Hospital Universitario Arnau de Vilanova de Lleida
    • Madrid, Comunidad DE
      • Madrid, Madrid, Comunidad DE, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
    • Málaga
      • Malaga, Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
    • PAÍS Vasco
      • Bilbao, PAÍS Vasco, Spain, 48013
        • Recruiting
        • Osi Bilbao-Basurto
  • Sweden
      • Sundsvall, Sweden, 856 43
        • Not yet recruiting
        • Sundsvalls Sjukhus
    • Stockholms LÄN [se-01]
      • Stockholm, Stockholms LÄN [se-01], Sweden, 11883
        • Not yet recruiting
        • Södersjukhuset
  • Switzerland
      • Winterthur, Switzerland, 8401
        • Recruiting
        • Kantonsspital Winterthur
    • Aargau
      • Aarau, Aargau, Switzerland, 5000
        • Recruiting
        • Tumor Zentrum Aarau
    • Grisons
      • Chur, Grisons, Switzerland, 7000
        • Not yet recruiting
        • Kantonsspital Graubünden
    • Thurgau
      • Frauenfeld, Thurgau, Switzerland, 8500
        • Recruiting
        • Kantonsspital Frauenfeld - Spital Thurgau AG
      • Münsterlingen, Thurgau, Switzerland, CH8596
        • Recruiting
        • Kantonsspital Münsterlingen - Spital Thurgau AG
    • Ticino
      • Bellinzona, Ticino, Switzerland, 6500
        • Recruiting
        • Ospedale Regionale Bellinzona e Valli
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
      • Tainan, Taiwan, 704
        • Not yet recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan, 10449
        • Recruiting
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 112
        • Recruiting
        • Koo Foundation Sun Yat-Sen Cancer Center
      • Taipei, Taiwan, 116
        • Recruiting
        • Taipei Municipal Wan Fang Hospital
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch
    • Changhua
      • Changhua County, Changhua, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung
    • Tainan
      • Tainan City, Tainan, Taiwan, 73657
        • Recruiting
        • Chi Mei Hospital - Liouying Branch
      • Tainan City, Tainan, Taiwan, 71004
        • Recruiting
        • Chi Mei Medical Center
  • Turkey
      • Adana, Turkey, 01370
        • Recruiting
        • Adana Sehir Egitim ve Arastirma Hastanesi
      • Ankara, Turkey, 06520
        • Recruiting
        • Memorial Ankara Hastanesi
      • Ankara, Turkey, 06010
        • Not yet recruiting
        • Gulhane Egitim Arastirma Hastanesi
      • Antalya, Turkey, 07059
        • Not yet recruiting
        • Akdeniz Universitesi Hastanesi
    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkey, 34722
        • Not yet recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
  • United Kingdom
      • Blackburn, United Kingdom, BB2 3HH
        • Not yet recruiting
        • Royal Blackburn Hospital
    • London, CITY OF
      • London, London, CITY OF, United Kingdom, EC1A 7BE
        • Not yet recruiting
        • St Bartholomew's Hospital
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Not yet recruiting
        • The Churchill Hospital
  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Recruiting
        • Comprehensive Blood And Cancer Center
      • Bakersfield, California, United States, 93309
        • Recruiting
        • CBCC Global Research, Inc.
      • Encinitas, California, United States, 92024
        • Recruiting
        • California Cancer Associates for Research and Excellence, Inc. (cCARE)
      • Fresno, California, United States, 93720
        • Recruiting
        • California Cancer Associates For Research and Excellence
      • Napa, California, United States, 94558
        • Recruiting
        • Providence Queen of the Valley Medical Center
      • San Marcos, California, United States, 92069
        • Recruiting
        • California Cancer Associates For Research and Excellence
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
      • Sylmar, California, United States, 91342
        • Recruiting
        • Olive View-UCLA Medical Center
      • Torrance, California, United States, 90505
        • Recruiting
        • Torrance Memorial Physician Network / Cancer Care
      • Torrance, California, United States, 90505
        • Recruiting
        • TMPN Cancer Care research office
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Not yet recruiting
        • Smilow Cancer Hospital Care Center at Fairfield
      • New Haven, Connecticut, United States, 06510
        • Not yet recruiting
        • Yale-New Haven Hospital
      • New Haven, Connecticut, United States, 06510
        • Not yet recruiting
        • Smilow Cancer Hospital at Yale-New Haven
      • North Haven, Connecticut, United States, 06473
        • Not yet recruiting
        • Smilow Cancer Hospital Care Center at North Haven
      • Trumbull, Connecticut, United States, 06611
        • Not yet recruiting
        • Smilow Cancer Hospital Care Center at Trumbull
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Recruiting
        • Florida Cancer Specialists
      • Bonita Springs, Florida, United States, 34135
        • Recruiting
        • Florida Cancer Specialists BON
      • Bradenton, Florida, United States, 34205
        • Recruiting
        • Florida Cancer Specialists BCC
      • Bradenton, Florida, United States, 34211
        • Recruiting
        • Florida Cancer Specialists LRS
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Florida Cancer Specialists
      • Cape Coral, Florida, United States, 33909
        • Recruiting
        • Florida Cancer Specialists NFM
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Morton Plant Hospital - Baycare Health System
      • Clearwater, Florida, United States, 33761
        • Recruiting
        • Florida Cancer Specialists
      • Coconut Creek, Florida, United States, 33073
        • Recruiting
        • 3T Radiology LLC
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Florida Cancer Specialists
      • Fleming Island, Florida, United States, 32003
        • Recruiting
        • Florida Cancer Specialists
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists - South
      • Fort Myers, Florida, United States, 33905
        • Recruiting
        • Florida Cancer Specialists COL
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • Florida Cancer Specialists GLO
      • Gainesville, Florida, United States, 32605
        • Recruiting
        • Florida Cancer Specialists
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Lakeland Regional Cancer Center
      • Largo, Florida, United States, 33770
        • Recruiting
        • Florida Cancer Specialists
      • Lauderdale Lakes, Florida, United States, 33313
        • Recruiting
        • Broward P.E.T. Imaging Center
      • Lecanto, Florida, United States, 34461
        • Recruiting
        • Florida Cancer Specialists
      • Naples, Florida, United States, 34102
        • Recruiting
        • Florida Cancer Specialists NGD
      • Naples, Florida, United States, 34102
        • Recruiting
        • Florida Cancer Specialists NPW
      • Ocala, Florida, United States, 34474
        • Recruiting
        • Florida Cancer Specialists
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Mid Florida Hematology and Oncology Center
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Florida Cancer Specialists
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Florida Cancer Specialists
      • Plantation, Florida, United States, 33322
        • Recruiting
        • BRCR Global
      • Plantation, Florida, United States, 33313
        • Recruiting
        • POM MRI & Radiology Centers
      • Port Charlotte, Florida, United States, 33980
        • Recruiting
        • Florida Cancer Specialists PCH
      • Saint Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialists
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists SAC
      • Sarasota, Florida, United States, 34236
        • Recruiting
        • Florida Cancer Specialists SAD
      • Stuart, Florida, United States, 34994
        • Recruiting
        • Florida Cancer Specialists
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Florida Cancer Specialists
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Impression Imaging
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Florida Cancer Specialists
      • The Villages, Florida, United States, 32159
        • Recruiting
        • Florida Cancer Specialists
      • Trinity, Florida, United States, 34655
        • Recruiting
        • Florida Cancer Specialist
      • Venice, Florida, United States, 34285
        • Recruiting
        • Florida Cancer Specialists VIS
      • Venice, Florida, United States, 34292
        • Recruiting
        • Florida Cancer Specialists VHP
      • Vero Beach, Florida, United States, 32960
        • Recruiting
        • Florida Cancer Specialists
      • Wellington, Florida, United States, 33414
        • Recruiting
        • Florida Cancer Specialists
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Florida Cancer Specialists
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Cancer Institute, Downtown
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • Norton Brownsboro Hospital
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Cancer Institute - Downtown
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • Norton Cancer Institute, Brownsboro Hospital Campus
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Cancer Institute, St Matthews Campus
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Hospital
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Women's & Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Louisiana State University Health Sciences Shreveport
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Recruiting
        • Hattiesburg Clinic Hematology/Oncology
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Mercy Clinic Oncology and Hematology
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Research - David C. Pratt Cancer Center
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Not yet recruiting
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • MSK Basking Ridge
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • MSK Monmouth
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering - Bergen
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • MSK Commack
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Hematology-Oncology Associates of Central New York, PC
      • Harrison, New York, United States, 10604
        • Recruiting
        • MSK Westchester
      • Long Island City, New York, United States, 11101
        • Recruiting
        • MSKCC Investigational Drug Service Pharmacy
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Recruiting
        • MSK Evelyn H. Lauder Breast and Imaging Center
      • Nyack, New York, United States, 10960
        • Recruiting
        • Hematology Oncology Associates of Rockland
      • Uniondale, New York, United States, 11553
        • Recruiting
        • MSK Nassau
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Recruiting
        • Cancer Centers of Southwest Oklahoma
      • Lawton, Oklahoma, United States, 73506
        • Recruiting
        • Cancer Centers of Southwest Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Recruiting
        • Hightower Clinical Trial Services
      • Oklahoma City, Oklahoma, United States, 73102
        • Recruiting
        • Frank C Love Cancer Institute
      • Oklahoma City, Oklahoma, United States, 73102
        • Recruiting
        • SSM Health Medical Group - St Anthony
    • Oregon
      • Portland, Oregon, United States, 97213
        • Not yet recruiting
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97213
        • Not yet recruiting
        • Providence Cancer Institute Franz Clinic
    • Tennessee
      • Dickson, Tennessee, United States, 37055
        • Recruiting
        • Tennessee Oncology, PLLC
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Tennessee Oncology PLLC
      • Gallatin, Tennessee, United States, 37066
        • Recruiting
        • Tennessee Oncology PLLC
      • Hendersonville, Tennessee, United States, 37075
        • Recruiting
        • Tennessee Oncology PLLC
      • Hermitage, Tennessee, United States, 37076
        • Recruiting
        • Tennessee Oncology PLLC
      • Lebanon, Tennessee, United States, 37090
        • Recruiting
        • Tennessee Oncology PLLC
      • Murfreesboro, Tennessee, United States, 37129
        • Recruiting
        • Tennessee Oncology PLLC
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology PLLC
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • Tennessee Oncology PLLC
      • Nashville, Tennessee, United States, 37207
        • Recruiting
        • Tennessee Oncology PLLC
      • Nashville, Tennessee, United States, 37211
        • Recruiting
        • Tennessee Oncology PLLC
      • Shelbyville, Tennessee, United States, 37160
        • Recruiting
        • Tennessee Oncology, PLLC
      • Smyrna, Tennessee, United States, 37167
        • Recruiting
        • Tennessee Oncology PLLC
    • Texas
      • Harlingen, Texas, United States, 78550
        • Recruiting
        • Valley Cancer Associates
      • Tyler, Texas, United States, 75701
        • Recruiting
        • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Recruiting
        • Hematology Oncology Associates of Fredericksburg
      • Mechanicsville, Virginia, United States, 23116
        • Recruiting
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours St. Francis Medical Center
      • Midlothian, Virginia, United States, 23114
        • Not yet recruiting
        • Bon Secours Cancer Institute at St. Francis
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Bon Secours St. Mary's Hospital
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Not yet recruiting
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From randomization date (every 3 months) to date of death (approximately 3 years)
Overall survival is defined as the time interval from the date of randomization to the date of documented death due to any cause.
From randomization date (every 3 months) to date of death (approximately 3 years)
Objective Response Rate (ORR)
Time Frame: From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death (approximately to 2 years).
Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1, from the date of randomization to the date of disease progression, death due to any cause, whichever occurs first.
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death (approximately to 2 years).
Duration of response (DR)
Time Frame: From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) to the date of disease progression or death (approximately to 2 years).
Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by BICR assessment as per RECIST 1.1 or death due to any cause, whichever occurs first.
From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) to the date of disease progression or death (approximately to 2 years).
Clinical Benefit Rate
Time Frame: From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression or death (approximately to 2 years).
Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR at any time, or SD or nonCR/non PD for at least 24 weeks determined by BICR assessment as per RECIST 1.1, from the date of randomization until disease progression, death due to any cause, whichever occurs first.
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression or death (approximately to 2 years).
Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), electrocardiogram (ECG) and laboratory abnormalities
Time Frame: From screening until 28 days after the last dose (approximately 2 years).
Incidence of participants with TEAEs, SAEs ECGs and laboratory abnormalities. TEAE/SAE and laboratory abnormalities will be graded according to NCI CTCAE V5.
From screening until 28 days after the last dose (approximately 2 years).
QT Interval (QTc)
Time Frame: From baseline to end of treatment (approximately 2 years).
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) are performed.
From baseline to end of treatment (approximately 2 years).
Plasma Concentration Versus Time of ARV-471
Time Frame: From randomization date up to cycle 7 (each cycle is 28 days).
Plasma concentrations of ARV-471
From randomization date up to cycle 7 (each cycle is 28 days).
Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
Time Frame: From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Change from baseline and time to deterioration between treatment comparison in Quality of Life using the EQ-5D 5L questionnaire.
From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Disease-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
Time Frame: From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Change from baseline and time to deterioration between treatment comparison in Quality of Life using the EORTC QLQ-C30 questionnaire.
From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Disease- and treatment-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer module (QLQ-BR23) questionnaire
Time Frame: From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Change from baseline and time to deterioration between treatment comparison in Quality of Life Using the EORTC QLQ-BR23 (Breast) questionnaire.
From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Clinical Pain and its impact on functioning will be assessed using Brief Pain Inventory Short Form (BPI-SF) questionnaire.
Time Frame: From screening and every cycle until cycle 6 (cycle=28 days) and then every other cycle until 28 days after the last dose (appr. 2 yrs).The modified BPI-SF (worst pain severity and pain interference) daily from baseline until the EOT (appr 2 yrs)
Change from baseline and time to deterioration between treatment comparison in Brief Pain Inventory Short Form questionnaire.
From screening and every cycle until cycle 6 (cycle=28 days) and then every other cycle until 28 days after the last dose (appr. 2 yrs).The modified BPI-SF (worst pain severity and pain interference) daily from baseline until the EOT (appr 2 yrs)
circulating deoxyribonucleic acid (DNA)
Time Frame: From baseline to end of treatment (approximately 2 years).
Quantitative changes from baseline
From baseline to end of treatment (approximately 2 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Arvinas Estrogen Receptor, Inc.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Estimated)

August 14, 2024

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)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on ARV-471

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