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

Advanced Breast Cancer Clinical Trial

— VERITAC-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654623
• Other study ID #: C4891001
• Secondary ID: 2022-500544-38-0
• Status: Recruiting
• Phase: Phase 3
• Start date: March 3, 2023
• Est. completion date: May 15, 2028

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: May 15, 2028
• Est. primary completion date: August 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Argentina	Centro Oncologico Korben	Buenos Aires
Argentina	Fundación Respirar	Buenos Aires
Argentina	Fundación Cenit Para La Investigación En Neurociencias	Caba	Ciudad Autónoma DE Buenos Aires
Argentina	Sanatorio de La Mujer	Rosario	Santa FE
Australia	Sunshine Coast University Private Hospital	Birtinya	Queensland
Australia	Sunshine Coast University Private Hospital	Birtinya	Queensland
Australia	Cabrini Hospital -Brighton	Brighton	Victoria
Australia	Barwon Health	Geelong	Victoria
Australia	Icon Cancer Centre Hobart	Hobart	Tasmania
Australia	Cabrini Hospital - Malvern	Malvern	Victoria
Belgium	Grand Hôpital de Charleroi	Charleroi	Hainaut
Belgium	Antwerp University Hospital	Edegem	Antwerpen
Belgium	UZ Leuven	Leuven	Vlaams-brabant
Belgium	Cliniques universitaires Saint-Luc	Woluwe-Saint-Lambert	Bruxelles-capitale, Région DE
Brazil	ONCOSITE - Centro de Pesquisa Clinica em Oncologia	Ijui	RIO Grande DO SUL
Brazil	Centro de Pesquisa Clínica - Área Administrativa	Porto Alegre	RIO Grande DO SUL
Brazil	Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital Mae de Deus	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital Moinhos de Vento	Porto Alegre	RIO Grande DO SUL
Brazil	Faculdade de Medicina do ABC	Santo André	SÃO Paulo
Brazil	A. C. Camargo Cancer Center	Sao Paulo	SÃO Paulo
Brazil	IBCC - Instituto Brasileiro de Controle do Câncer	São Paulo
Brazil	IBCC - Núcleo de Pesquisa e Ensino	São Paulo
Brazil	Hospital Santa Rita de Cassia	Vitoria	Espírito Santo
Bulgaria	Complex Oncology Center - Burgas	Burgas
Bulgaria	Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD	Gabrovo
Bulgaria	Specialized Hospital for Active Treatment of Oncology - Haskovo	Haskovo
Bulgaria	Complex Oncology Center - Plovdiv EOOD	Plovdiv
Bulgaria	Complex Oncology Center - Ruse EOOD	Ruse
Bulgaria	Complex Oncology Center - Vratsa	Vratsa
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Grand River Hospital	Kitchener	Ontario
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Unité de Recherche Clinique du CISSS des Laurentides	St-Jerome	Quebec
Canada	Unité de Recherche Clinique du CISSS des Laurentides	St-Jerome	Quebec
Canada	BC Cancer Surrey	Surrey	British Columbia
Canada	Sunnybrook Research Institute	Toronto	Ontario
Canada	Sunnybrook Research Institute	Toronto	Ontario
Canada	Unity Health Toronto, St. Michael's Hospital	Toronto	Ontario
China	The First Hospital of Jilin University	Changchun	Jilin
China	Fujian Medical University Union Hospital-1 Bingfanglou	Fuzhou Fujian	Fujian
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated hospital of Zhejiang University school of medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	Anhui Provincial Hospital	Hefei	Anhui
China	Shandong Cancer Hospital	Jinan	Shandong
China	Yunnan Province Cancer Hospital	Kunming	Yunnan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Wuhan Union Hospital Cancer Center	Wuhan	Hubei
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi/china
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Henan Cancer Hospital	Zhengzhou
Czechia	Fakultní nemocnice Brno Bohunice	Brno	Brno-mesto
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Bulovka	Prague	Praha 8
Czechia	Fakultni Thomayerova nemocnice	Prague	Praha 4
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Finland	Oulun yliopistollinen sairaala	Oulu	Pohjois-pohjanmaa
Finland	Satakunnan Keskussairaala	Pori
Finland	Tampereen yliopistollinen sairaala	Tampere	Pirkanmaa
Finland	Vaasan Keskussairaala	Vaasa	Pohjanmaa
France	Institut de Cancérologie de l'Ouest	ANGERS cedex 02	Maine-et-loire
France	Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne	Clermont-Ferrand	Puy-de-dôme
France	Henri Mondor Hospital	Créteil	Île-de-france
France	Centre Georges François Leclerc	Dijon	Côte-d'or
France	Centre Hospitalier Universitaire de Poitiers	Poitiers	Vienne
France	Institut de Cancérologie de l'Ouest	Saint Herblain	Loire-atlantique
Germany	Onkologische Schwerpunktpraxis Kurfuerstendamm	Berlin
Germany	Universitaetsklinikum Freiburg	Freiburg	Baden-württemberg
Germany	Gynäkologie Kompetenzzentrum Stralsund	Stralsund	Mecklenburg-vorpommern
Greece	Alexandra General Hospital of Athens	Athens	Attikí
Greece	Attikon General University Hospital	Chaidari/Athens	Attikí
Greece	University General Hospital of Heraklion	Heraklion	Irakleío
Greece	University General Hospital of Larissa	Larissa	Thessalía
Greece	University Hospital of Patras	Patras	Acha?a
Hungary	Budapesti Uzsoki Utcai Kórház	Budapest
India	Artemis hospital	Gurgaon	Haryana
India	Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital	Kolkata	WEST Bengal
India	Tata Memorial Hospital	Mumbai	Maharashtra
India	HCG Manavata Cancer Centre	Nashik	Maharashtra
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	Rajiv Gandhi Cancer Institute And Research Centre	New Delhi	Delhi
India	Sahyadri Super Speciality Hospital, Hadapsar	Pune	Maharashtra
India	Bhakti Vedanta Hospital and Research Institute	Thane	Maharashtra
India	City Cancer Centre - Vijayawada	Vijayawada	Andhra Pradesh
India	Hcg Pet Imaging Centre	Vijayawada	Andhra Pradesh
Israel	Rabin Medical Center	Petah Tikva	Hamerkaz
Israel	Kaplan Medical Center	Rehovot	Hamerkaz
Israel	Yitzhak Shamir Medical Center	Zerifin	Hamerkaz
Italy	Azienda Ospedaliero Universitaria delle Marche	Ancona	Marche
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola	Bologna	Emilia-romagna
Italy	Ospedale Generale Provinciale Macerata	Macerata
Italy	Istituto Europeo di Oncologia IRCCS	Milano
Italy	Humanitas Istituto Clinico Catanese	Misterbianco	Catania
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza	Lombardia
Italy	Istituto Nazionale Tumori IRCCS Fondazione Pascale	Napoli	Campania
Italy	Istituto Oncologico Veneto IRCCS	Padova
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa	Toscana
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuor	Roma	Lazio
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Tokyo Metropolitan Komagome Hospital, Department of Breast Surgery	Bunkyo-ku	Tokyo
Japan	Chiba cancer center	Chiba-shi	Chiba
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Saitama Prefectural Cancer Center	Ina-machi	Saitama
Japan	Sagara Hospital	Kagoshima
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Japanese Foundation for Cancer Research	Koto	Tokyo
Japan	Cancer Institute Hospital of JFCR	Koto-ku	Tokyo
Japan	Aichi Cancer Center Hospital	Nagoya	Aichi
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Okayama University Hospital	Okayama
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	National Center for Global Health and Medicine	Shinjuku City	Tokyo
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjuku-ku	Tokyo
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjyuku-ku	Tokyo
Japan	Osaka University Hospital	Suita	Osaka
Japan	Juntendo University Hospital	Tokyo
Japan	Kanagawa cancer center	Yokohama	Kanagawa
Korea, Republic of	National Cancer Center	Goyang-si	Kyonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Namdong-gu	Incheon-gwangyeoksi [incheon]
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Korea University Anam Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Ajou University Hospital	Suwon	Kyonggi-do
Norway	Drammen Sykehus, Vestre Viken HF	Drammen	Buskerud
Norway	Akershus Universitetssykehus	Lorenskog	Akershus
Poland	KLIMED Marek Klimkiewicz	Bialystok	Podlaskie
Poland	COPERNICUS PL, Wojewodzkie Centrum Onkologii	Gdansk	Pomorskie
Poland	Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji sp. z o.o.	Kraków	Malopolskie
Poland	Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna	Lodz	Lódzkie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie	Warszawa	Mazowieckie
Puerto Rico	Puerto Rico Medical Research Center	Hato Rey
Puerto Rico	Pan American Center for Oncology Trials, LLC	Rio Piedras
Puerto Rico	Pan American Center for Oncology Trials- Hospital Oncologico	Rio Piedras
Puerto Rico	Auxilio Mutuo Cancer Center	San Juan
Puerto Rico	FDI Clinical Research	San Juan
Slovakia	Narodny onkologicky ustav	Bratislava
Slovakia	Onkologicky ustav sv. Alzbety, s.r.o.	Bratislava
Slovakia	Vychodoslovensky onkologicky ustav, a.s.	Kosice
Slovakia	Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.	Michalovce
Slovakia	Nemocnica na okraji mesta n o	Partizanske
Slovakia	Fakultna nemocnica s poliklinikou J.A. Reimana Presov	Presov
Slovakia	Fakultna nemocnica Trnava	Trnava
Slovakia	Fakultna nemocnica Trnava	Trnava
South Africa	Iatros International	Bloemfontein	FREE State
South Africa	Cancercare Rondebosch Oncology	Cape Town	Western CAPE
South Africa	15 Eton Road	Johannesburg	Gauteng
South Africa	Charlotte Maxeke Johannesburg Academic Hospital	Johannesburg	Gauteng
South Africa	Medical Oncology Centre of Rosebank	Johannesburg	Gauteng
South Africa	WCR Office	Johannesburg	Gauteng
South Africa	Wits Clinical Research	Johannesburg	Gauteng
Spain	CHUAC-Hospital Teresa Herrera	A Coruña	A Coruña [LA Coruña]
Spain	Institut Català d'Oncologia (ICO) - Badalona	Badalona	Barcelona [barcelona]
Spain	Parc de Salut Mar - Hospital del Mar	Barcelona	Barcelona [barcelona]
Spain	Osi Bilbao-Basurto	Bilbao	PAÍS Vasco
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital Universitario Virgen Nieves	Granada
Spain	Hospital Unviersitario Virgen Nieves	Granada
Spain	Institut Català d'Oncologia - L'Hospitalet	L'Hospitalet de Llobregat	Catalunya [cataluña]
Spain	Hospital Universitario Arnau de Vilanova de Lleida	Lleida	Lleida [lérida]
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid	Madrid, Comunidad DE
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Malaga	Málaga
Spain	Althaia, Xarxa Assistencial Universitària de Manresa	Manresa
Spain	Hospital Universitario Donostia	San Sebastian	Gipuzkoa
Sweden	Södersjukhuset	Stockholm	Stockholms LÄN [se-01]
Sweden	Sundsvalls Sjukhus	Sundsvall
Switzerland	Tumor Zentrum Aarau	Aarau	Aargau
Switzerland	Ospedale Regionale Bellinzona e Valli	Bellinzona	Ticino
Switzerland	Kantonsspital Graubünden	Chur	Grisons
Switzerland	Kantonsspital Frauenfeld - Spital Thurgau AG	Frauenfeld	Thurgau
Switzerland	Kantonsspital Münsterlingen - Spital Thurgau AG	Münsterlingen	Thurgau
Switzerland	Kantonsspital Winterthur	Winterthur
Taiwan	Changhua Christian Hospital	Changhua County	Changhua
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung Niao Sung Dist	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chi Mei Hospital - Liouying Branch	Tainan City	Tainan
Taiwan	Chi Mei Medical Center	Tainan City	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Municipal Wan Fang Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
Turkey	Adana Sehir Egitim ve Arastirma Hastanesi	Adana
Turkey	Gulhane Egitim Arastirma Hastanesi	Ankara
Turkey	Memorial Ankara Hastanesi	Ankara
Turkey	Akdeniz Universitesi Hastanesi	Antalya
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi	Istanbul	I?stanbul
United Kingdom	Royal Blackburn Hospital	Blackburn
United Kingdom	St Bartholomew's Hospital	London	London, CITY OF
United Kingdom	The Churchill Hospital	Oxford	Oxfordshire
United States	Florida cancer specialists	Altamonte Springs	Florida
United States	CBCC Global Research, Inc.	Bakersfield	California
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Mercy Clinic Oncology and Hematology	Ballwin	Missouri
United States	MSK Basking Ridge	Basking Ridge	New Jersey
United States	Florida Cancer Specialists BON	Bonita Springs	Florida
United States	Florida Cancer Specialists BCC	Bradenton	Florida
United States	Florida Cancer Specialists LRS	Bradenton	Florida
United States	Florida Cancer Specialists	Brandon	Florida
United States	Florida Cancer Specialists NFM	Cape Coral	Florida
United States	Florida Cancer Specialists	Clearwater	Florida
United States	Morton Plant Hospital - BayCare Health System	Clearwater	Florida
United States	3T Radiology LLC	Coconut Creek	Florida
United States	MSK Commack	Commack	New York
United States	Florida Cancer Specialists	Daytona Beach	Florida
United States	Tennessee Oncology, PLLC	Dickson	Tennessee
United States	Astera Cancer Care	East Brunswick	New Jersey
United States	Hematology-Oncology Associates of Central New York, PC	East Syracuse	New York
United States	California Cancer Associates for Research and Excellence, Inc. (cCARE)	Encinitas	California
United States	Smilow Cancer Hospital Care Center at Fairfield	Fairfield	Connecticut
United States	Florida Cancer Specialists	Fleming Island	Florida
United States	Florida Cancer Specialists - South	Fort Myers	Florida
United States	Florida Cancer Specialists COL	Fort Myers	Florida
United States	Florida Cancer Specialists GLO	Fort Myers	Florida
United States	Tennessee Oncology PLLC	Franklin	Tennessee
United States	Hematology Oncology Associates of Fredericksburg	Fredericksburg	Virginia
United States	California Cancer Associates for Research and Excellence	Fresno	California
United States	Florida Cancer Specialists	Gainesville	Florida
United States	Tennessee Oncology PLLC	Gallatin	Tennessee
United States	Valley Cancer Associates	Harlingen	Texas
United States	MSK Westchester	Harrison	New York
United States	Hattiesburg Clinic Hematology/Oncology	Hattiesburg	Mississippi
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Tennessee Oncology PLLC	Hendersonville	Tennessee
United States	Tennessee Oncology PLLC	Hermitage	Tennessee
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Florida Cancer Specialists	Largo	Florida
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Broward P.E.T. Imaging Center	Lauderdale Lakes	Florida
United States	Cancer Centers of Southwest Oklahoma	Lawton	Oklahoma
United States	Cancer Centers of Southwest Oklahoma	Lawton	Oklahoma
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Tennessee Oncology PLLC	Lebanon	Tennessee
United States	Florida Cancer Specialists	Lecanto	Florida
United States	MSKCC Investigational Drug Service Pharmacy	Long Island City	New York
United States	Norton Brownsboro Hospital	Louisville	Kentucky
United States	Norton Cancer Institute - Downtown	Louisville	Kentucky
United States	Norton Cancer Institute, Brownsboro Hospital Campus	Louisville	Kentucky
United States	Norton Cancer Institute, Downtown	Louisville	Kentucky
United States	Norton Cancer Institute, St Matthews Campus	Louisville	Kentucky
United States	Norton Hospital	Louisville	Kentucky
United States	Norton Women's & Children's Hospital	Louisville	Kentucky
United States	Bon Secours Memorial Regional Medical Center	Mechanicsville	Virginia
United States	MSK Monmouth	Middletown	New Jersey
United States	Bon Secours Cancer Institute at St. Francis	Midlothian	Virginia
United States	Bon Secours St. Francis Medical Center	Midlothian	Virginia
United States	Memorial Sloan Kettering - Bergen	Montvale	New Jersey
United States	West Virginia University	Morgantown	West Virginia
United States	Tennessee Oncology PLLC	Murfreesboro	Tennessee
United States	Providence Queen of the Valley Medical Center	Napa	California
United States	Florida Cancer Specialists NGD	Naples	Florida
United States	Florida Cancer Specialists NPW	Naples	Florida
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Smilow Cancer Hospital at Yale-New Haven	New Haven	Connecticut
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	MSK Evelyn H. Lauder Breast and Imaging Center	New York	New York
United States	Smilow Cancer Hospital Care Center at North Haven	North Haven	Connecticut
United States	Hematology Oncology Associates of Rockland	Nyack	New York
United States	Florida Cancer Specialists	Ocala	Florida
United States	Frank C Love Cancer Institute	Oklahoma City	Oklahoma
United States	Hightower Clinical Trial Services	Oklahoma City	Oklahoma
United States	SSM Health Medical Group - St Anthony	Oklahoma City	Oklahoma
United States	Florida Cancer specialists	Orange City	Florida
United States	Mid Florida Hematology and Oncology Center	Orange City	Florida
United States	Florida Cancer Specialists	Orlando	Florida
United States	BRCR Global	Plantation	Florida
United States	POM MRI & Radiology Centers	Plantation	Florida
United States	Florida Cancer Specialists PCH	Port Charlotte	Florida
United States	Providence Cancer Institute Franz Clinic	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon
United States	Bon Secours St. Mary's Hospital	Richmond	Virginia
United States	Mercy Research - David C. Pratt Cancer Center	Saint Louis	Missouri
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	California Cancer Associates for Research and Excellence	San Marcos	California
United States	Providence Medical Foundation	Santa Rosa	California
United States	Florida Cancer Specialists SAC	Sarasota	Florida
United States	Florida Cancer Specialists SAD	Sarasota	Florida
United States	Tennessee Oncology, PLLC	Shelbyville	Tennessee
United States	Louisiana State University Health Sciences Shreveport	Shreveport	Louisiana
United States	Tennessee Oncology PLLC	Smyrna	Tennessee
United States	Florida Cancer Specialists	Stuart	Florida
United States	Olive View-UCLA Medical Center	Sylmar	California
United States	Florida Cancer Specialists	Tallahassee	Florida
United States	Impression Imaging	Tamarac	Florida
United States	Florida Cancer Specialists	Tampa	Florida
United States	Florida Cancer Specialists	The Villages	Florida
United States	TMPN Cancer Care research office	Torrance	California
United States	Torrance Memorial Physician Network / Cancer Care	Torrance	California
United States	Florida Cancer Specialist	Trinity	Florida
United States	Smilow Cancer Hospital Care Center at Trumbull	Trumbull	Connecticut
United States	The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center	Tyler	Texas
United States	MSK Nassau	Uniondale	New York
United States	Florida Cancer Specialists VHP	Venice	Florida
United States	Florida Cancer Specialists VIS	Venice	Florida
United States	Florida Cancer Specialists	Vero Beach	Florida
United States	Florida Cancer Specialists	Wellington	Florida
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	Florida Cancer Specialists	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Arvinas Estrogen Receptor, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Puerto Rico,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	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	Overall survival (OS)	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)
Secondary	Objective Response Rate (ORR)	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).
Secondary	Duration of response (DR)	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).
Secondary	Clinical Benefit Rate	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).
Secondary	Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), electrocardiogram (ECG) and laboratory abnormalities	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).
Secondary	QT Interval (QTc)	Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) are performed.	From baseline to end of treatment (approximately 2 years).
Secondary	Plasma Concentration Versus Time of ARV-471	Plasma concentrations of ARV-471	From randomization date up to cycle 7 (each cycle is 28 days).
Secondary	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)	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).
Secondary	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)	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).
Secondary	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	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).
Secondary	Clinical Pain and its impact on functioning will be assessed using Brief Pain Inventory Short Form (BPI-SF) questionnaire.	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)
Secondary	circulating deoxyribonucleic acid (DNA)	Quantitative changes from baseline	From baseline to end of treatment (approximately 2 years).

External Links

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