NCT05654623

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
624

participants targeted

Target at P75+ for phase_3

Timeline
24mo left

Started Mar 2023

Longer than P75 for phase_3

Geographic Reach
30 countries

310 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Mar 2023May 2028

First Submitted

Initial submission to the registry

November 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 3, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 3, 2026

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2028

Expected
Last Updated

March 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

November 16, 2022

Results QC Date

January 15, 2026

Last Update Submit

February 27, 2026

Conditions

Keywords

ER(+)/HER2(-) Advanced Breast CancerAdvanced cancer of the breastBreast neoplasmBreast tumorBreast cancerFulvestrantEstrogen receptor positiveMetastatic breast cancerER degraderPROTACHormone TherapyHormone positive breast cancerEndocrine therapyRecurrent breast cancerHR+HER2-negativeVepdegestrant

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (16)

  • Overall Survival (OS)-All Randomized Participants

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

  • OS-Participants With ESR1 Mutation

    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

    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

    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

    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)

  • +11 more secondary outcomes

Study Arms (2)

ARV-471

EXPERIMENTAL
Drug: ARV-471

Fulvestrant

ACTIVE COMPARATOR
Drug: Fulvestrant

Interventions

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

Also known as: PF-07850327
ARV-471

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

Fulvestrant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (312)

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

Encinitas, California, 92024, United States

Location

Orange Coast Memorial Medical Center

Fountain Valley, California, 92708, United States

Location

California Cancer Associates for Research and Excellence

Fresno, California, 93720, United States

Location

Providence Queen of the Valley Medical Center

Napa, California, 94558, United States

Location

California Cancer Associates for Research and Excellence

San Marcos, California, 92069, United States

Location

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

Smilow Cancer Hospital Care Center at Fairfield

Fairfield, Connecticut, 06824, United States

Location

Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, 06510, United States

Location

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Smilow Cancer Hospital Care Center at North Haven

North Haven, Connecticut, 06473, United States

Location

Smilow Cancer Hospital Care Center at Trumbull

Trumbull, Connecticut, 06611, United States

Location

Florida Cancer Specialists

Altamonte Springs, Florida, 32701, United States

Location

Florida Cancer Specialists BON

Bonita Springs, Florida, 34135, United States

Location

Florida Cancer Specialists BCC

Bradenton, Florida, 34205, United States

Location

Florida Cancer Specialists LRS

Bradenton, Florida, 34211, United States

Location

Florida Cancer Specialists

Brandon, Florida, 33511, United States

Location

Florida Cancer Specialists NFM

Cape Coral, Florida, 33909, United States

Location

Morton Plant Hospital - BayCare Health System

Clearwater, Florida, 33756, United States

Location

Florida Cancer Specialists

Clearwater, Florida, 33761, United States

Location

Florida Cancer Specialists

Daytona Beach, Florida, 32117, United States

Location

Florida Cancer Specialists COL

Fort Myers, Florida, 33905, United States

Location

Florida Cancer Specialists GLO

Fort Myers, Florida, 33908, United States

Location

Florida Cancer Specialists

Gainesville, Florida, 32605, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

Florida Cancer Specialists

Largo, Florida, 33770, United States

Location

Florida Cancer Specialists

Lecanto, Florida, 34461, United States

Location

Florida Cancer Specialist And Research Institute

N. Venice, Florida, 34275, United States

Location

Florida Cancer Specialists NGD

Naples, Florida, 34102, United States

Location

Florida Cnacer Specialists

North Port, Florida, 34286, United States

Location

Florida Cancer Specialists

Ocala, Florida, 34474, United States

Location

Florida Cancer Specialists

Orange City, Florida, 32763, United States

Location

Florida Cancer Specialists

Orlando, Florida, 32806, United States

Location

Florida Cancer Specialists PCH

Port Charlotte, Florida, 33980, United States

Location

Florida Cancer Specialists SAC

Sarasota, Florida, 34232, United States

Location

Florida Cancer Specialists SAD

Sarasota, Florida, 34236, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists

Stuart, Florida, 34994, United States

Location

Florida Cancer Specialists

Tampa, Florida, 33607, United States

Location

Florida Cancer Specialists

Tavares, Florida, 32778, United States

Location

Florida Cancer Specialists

The Villages, Florida, 32159, United States

Location

Florida Cancer Specialist

Trinity, Florida, 34655, United States

Location

Florida Cancer Specialists

Vero Beach, Florida, 32960, United States

Location

Florida Cancer Specialists

Wellington, Florida, 33414, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Florida Cancer Specialists

Winter Park, Florida, 32789, United States

Location

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

Location

Norton Cancer Institute - Downtown

Louisville, Kentucky, 40202, United States

Location

Norton Cancer Institute, Downtown

Louisville, Kentucky, 40202, United States

Location

Norton Hospital

Louisville, Kentucky, 40202, United States

Location

Norton Cancer Institute, St Matthews Campus

Louisville, Kentucky, 40207, United States

Location

Norton Women's & Children's Hospital

Louisville, Kentucky, 40207, United States

Location

Norton Brownsboro Hospital

Louisville, Kentucky, 40241, United States

Location

Norton Cancer Institute, Brownsboro Hospital Campus

Louisville, Kentucky, 40241, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, 71103, United States

Location

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401, United States

Location

Mercy Clinic Oncology and Hematology

Ballwin, Missouri, 63011, United States

Location

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

Location

Mercy Research - David C. Pratt Cancer Center

St Louis, Missouri, 63141, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MSK Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

MSK Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering - Bergen

Montvale, New Jersey, 07645, United States

Location

Hematology Oncology Associates of CNY

Camillus, New York, 13031, United States

Location

MSK Commack

Commack, New York, 11725, United States

Location

Hematology-Oncology Associates of Central New York, PC

East Syracuse, New York, 13057, United States

Location

MSK Westchester

Harrison, New York, 10604, United States

Location

R.J. Zuckerberg Cancer Center

Lake Success, New York, 11042, United States

Location

Northern Westchester Hospital

Mount Kisco, New York, 10549, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MSK Evelyn H. Lauder Breast and Imaging Center

New York, New York, 10065, United States

Location

Hematology Oncology Associates of Rockland

Nyack, New York, 10960, United States

Location

Phelps Hospital

Sleepy Hollow, New York, 10591, United States

Location

MSK Nassau

Uniondale, New York, 11553, United States

Location

Cancer Centers of Southwest Oklahoma

Lawton, Oklahoma, 73505, United States

Location

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22903, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

UVA Breast Care Center

Charlottesville, Virginia, 22911, United States

Location

Bon Secours Memorial Regional Medical Center

Mechanicsville, Virginia, 23116, United States

Location

Bon Secours St. Francis Medical Center

Midlothian, Virginia, 23114, United States

Location

Bon Secours St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Providence Regional Cancer System - Aberdeen

Aberdeen, Washington, 98520, United States

Location

Providence Regional Cancer System- Centralia

Centralia, Washington, 98531, United States

Location

Providence Regional Cancer System - Lacey

Lacey, Washington, 98503, United States

Location

UW Medicine Valley Medical Center

Renton, Washington, 98055, United States

Location

Centro de Oncología e Investigación de Buenos Aires

Berazategui, Buenos Aires, B1884BBF, Argentina

Location

Instituto de Oncología Angel H. Roffo

CABA, Buenos Aires, 1417, Argentina

Location

Stat Research S.A.

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1023AAB, Argentina

Location

Fundación Cenit Para La Investigación En Neurociencias

CABA, Buenos Aires F.D., 1125, Argentina

Location

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, 2000, Argentina

Location

Sanatorio de La Mujer

Rosario, Santa Fe Province, S2000ORE, Argentina

Location

Centro Oncologico Korben

Buenos Aires, 1426, Argentina

Location

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

Buenos Aires, 1431, Argentina

Location

Fundación Respirar

Buenos Aires, C1426ABP, Argentina

Location

Clínica Universitaria Reina Fabiola

Córdoba, X5004FHP, Argentina

Location

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, 2450, Australia

Location

Sunshine Coast University Private Hospital

Birtinya, Queensland, 4575, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

ICON Cancer Centre - Kurralta Park

Kurralta Park, South Australia, 5037, Australia

Location

Icon Cancer Centre Hobart

Hobart, Tasmania, 7000, Australia

Location

Cabrini Hospital -Brighton

Brighton, Victoria, 3186, Australia

Location

Barwon Health

Geelong, Victoria, 3220, Australia

Location

Cabrini Hospital - Malvern

Malvern, Victoria, 3144, Australia

Location

Medizinische Universität Graz

Graz, Styria, 8036, Austria

Location

Uniklinikum Salzburg

Salzburg, 5020, Austria

Location

Antwerp University Hospital

Edegem, Antwerpen, 2650, Belgium

Location

Cliniques universitaires Saint-Luc

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

Location

Grand Hôpital de Charleroi

Gilly, Hainaut, 6060, Belgium

Location

UZ Leuven

Leuven, Vlaams-brabant, 3000, Belgium

Location

Clinical Chc Montlégia

Liège, 4000, Belgium

Location

Hospital Santa Rita de Cassia

Vitória, Espírito Santo, 29043-260, Brazil

Location

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90560032, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Centro de Pesquisa Clínica - Área Administrativa

Porto Alegre, Rio Grande do Sul, 90850-170, Brazil

Location

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

Location

ANIMI - Unidade de Tratamento Oncologico

Lages, Santa Catarina, 88501001, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

Location

A. C. Camargo Cancer Center

São Paulo, São Paulo, 01509-010, Brazil

Location

IBCC - Instituto Brasileiro de Controle do Câncer

São Paulo, 03102002, Brazil

Location

IBCC - Núcleo de Pesquisa e Ensino

São Paulo, 04014-002, Brazil

Location

Complex Oncology Center - Burgas

Burgas, 8000, Bulgaria

Location

Complex Oncology Center - Plovdiv EOOD

Plovdiv, 4004, Bulgaria

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Surrey

Surrey, British Columbia, V3V 1Z2, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Waterloo Regional Health Network

Kitchener, Ontario, N2G 1G3, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Centre de Services Ambulatoires de St-Jerome

Saint-Jérôme, Quebec, J7Y 0L1, Canada

Location

Unité de Recherche Clinique du CISSS des Laurentides

Saint-Jérôme, Quebec, J7Z 2V4, Canada

Location

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100005, China

Location

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Fujian Medical University Union Hospital

Fuzhou Fujian, Fujian, 350001, China

Location

The First People's Hospital of Foshan

Foshan, Guangdong, 528041, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510555, China

Location

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, 530201, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, Henan, 471003, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Wuhan Union Hospital Cancer Center

Wuhan, Hubei, 430022, China

Location

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

Wuhan, Hubei, 430040, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

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

Nanjing, Jiangsu, 210031, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Nanchang People's Hospital

Nanchang, Jiangxi, 330009, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The 2nd Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116023, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, 110042, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Yunnan Province Cancer Hospital

Kunming, Yunnan, 650106, China

Location

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

The Second Affiliated hospital of Zhejiang University school of medicine

Hangzhou, Zhejiang, 310052, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

Fakultní nemocnice Brno Bohunice

Brno, Brno-město, 625 00, Czechia

Location

Fakultni Thomayerova nemocnice

Prague, Praha 4, 14059, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 10034, Czechia

Location

Tampereen yliopistollinen sairaala

Tampere, Pirkanmaa, 33520, Finland

Location

Vaasan Keskussairaala

Vaasa, Pohjanmaa, 65130, Finland

Location

Satakunnan Keskussairaala

Pori, 28500, Finland

Location

Centre Georges François Leclerc

Dijon, Côte-d'or, 21079, France

Location

Centre de Cancérologie du Grand Montpellier

Montpellier, Languedoc-roussillon, 34070, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire-atlantique, 44805, France

Location

Institut de Cancérologie de l'Ouest

Angers, Maine-et-loire, 49055, France

Location

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

Clermont-Ferrand, Puy-de-dôme, 63011, France

Location

Sainte Catherine Institut du Cancer Avignon Provence

Avignon, Vaucluse, 84918, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, Vienne, 86021, France

Location

Henri Mondor Hospital

Créteil, Île-de-France Region, 94000, France

Location

Onkologische Schwerpunktpraxis Kurfuerstendamm

Berlin, 10707, Germany

Location

University Hospital of Patras

Pátrai, Achaḯa, 26504, Greece

Location

Alexandra General Hospital of Athens

Athens, Attikí, 115 28, Greece

Location

Attikon General University Hospital

Chaidari/Athens, Attikí, 12462, Greece

Location

University General Hospital of Heraklion

Heraklion, Irakleío, 715 00, Greece

Location

University General Hospital of Larissa

Larissa, Thessalía, 41110, Greece

Location

Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

Budapesti Uzsoki Utcai Kórház

Budapest, 1145, Hungary

Location

Artemis hospital

Gurgaon, Haryana, 122001, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

HCG Manavata Cancer Centre

Nashik, Maharashtra, 422002, India

Location

Apex Wellness Hospital

Nashik, Maharashtra, 422009, India

Location

Bhakti Vedanta Hospital and Research Institute

Thane, Maharashtra, 401107, India

Location

Venkateshwar Hospital

New Delhi, National Capital Territory of Delhi, 110075, India

Location

Rajiv Gandhi Cancer Institute And Research Centre

New Delhi, National Capital Territory of Delhi, 110085, India

Location

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

Kolkata, West Bengal, 700020, India

Location

Rabin Medical Center

Petah Tikva, Central District, 4941492, Israel

Location

Kaplan Medical Center

Rehovot, Central District, 7610001, Israel

Location

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Campania, 80131, Italy

Location

Humanitas Istituto Clinico Catanese

Misterbianco, Catania, 95045, Italy

Location

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

Bologna, Emilia-Romagna, 40138, Italy

Location

Azienda Ospedaliero Universitaria di Ferrara

Cona, Ferrara, 44124, Italy

Location

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

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, 20900, Italy

Location

Azienda Ospedaliero Universitaria delle Marche

Ancona, The Marches, 60126, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56126, Italy

Location

Ospedale Generale Provinciale Macerata

Macerata, 62100, Italy

Location

Istituto Europeo di Oncologia IRCCS

Milan, 20141, Italy

Location

Istituto Oncologico Veneto IRCCS

Padua, 35128, Italy

Location

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Chiba cancer center

Chiba, Chiba, 260-8717, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Kanagawa cancer center

Yokohama, Kanagawa, 2418515, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Saitama Prefectural Cancer Center

Ina-machi, Saitama, 362-0806, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Tokyo Metropolitan Komagome Hospital, Department of Breast Surgery

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

Location

Japanese Foundation for Cancer Research

Koto, Tokyo, 135-8550, Japan

Location

National Center for Global Health and Medicine

Shinjuku, Tokyo, 162-8655, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-ku, Tokyo, 162-8655, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Sagara Hospital

Kagoshima, 892-0833, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Boca Clinical Trials Mexico S.C.

Guadajalara, Jalisco, 44600, Mexico

Location

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

Cuauhtémoc, Mexico City, 06100, Mexico

Location

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, 68020, Mexico

Location

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

Krakow, Lesser Poland Voivodeship, 30-348, Poland

Location

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

COPERNICUS PL, Wojewodzkie Centrum Onkologii

Gdansk, Pomeranian Voivodeship, 80-219, Poland

Location

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

Lodz, Łódź Voivodeship, 90-338, Poland

Location

Puerto Rico Medical Research Center

Hato Rey, Puerto RICO, 00917, Puerto Rico

Location

Hospital Oncológico Dr. Isaac González-Martinez

Rio Piedras, 00935, Puerto Rico

Location

Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935, Puerto Rico

Location

FDI Clinical Research

San Juan, 00927, Puerto Rico

Location

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

Bratislava, 812 50, Slovakia

Location

Narodny onkologicky ustav

Bratislava, 833 10, Slovakia

Location

Vychodoslovensky onkologicky ustav, a.s.

Košice, 04191, Slovakia

Location

Nemocnica na okraji mesta n o

Partizánske, 95801, Slovakia

Location

Fakultna nemocnica Trnava

Trnava, 917 75, Slovakia

Location

Iatros International

Bloemfontein, Free State, 9301, South Africa

Location

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, 2193, South Africa

Location

WCR Office

Johannesburg, Gauteng, 2193, South Africa

Location

Wits Clinical Research

Johannesburg, Gauteng, 2193, South Africa

Location

Gachon University Gil Medical Center

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

Location

National Cancer Center

Goyang-si, Kyǒnggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea

Location

Ajou University Hospital

Suwon, Kyǒnggi-do, 16499, South Korea

Location

Korea University Anam Hospital

Seoul, Seoul-teukbyeolsi [seoul], 02841, South Korea

Location

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

Location

Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 06273, South Korea

Location

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

Location

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

Seoul, Seoul-teukbyeolsi [seoul], 06591, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Location

CHUAC-Hospital Teresa Herrera

A Coruña, A Coruña [LA Coruña], 15006, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Institut Català d'Oncologia (ICO) - Badalona

Badalona, Barcelona [barcelona], 08916, Spain

Location

Parc de Salut Mar - Hospital del Mar

Barcelona, Barcelona [barcelona], 08003, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035, Spain

Location

Osi Bilbao-Basurto

Bilbao, Basque Country, 48013, Spain

Location

Institut Català d'Oncologia - L'Hospitalet

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

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, Lleida [lérida], 25198, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

Location

Salut Sant Joan de Reus-Baix Camp (Edp)

Reus, Tarragona [tarragona], 43204, Spain

Location

Hospital Universitario Virgen Nieves

Granada, 18012, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Althaia, Xarxa Assistencial Universitària de Manresa

Manresa, 8423, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Södersjukhuset

Stockholm, Stockholms LÄN [se-01], 11883, Sweden

Location

Tumor Zentrum Aarau

Aarau, Canton of Aargau, 5000, Switzerland

Location

Kantonsspital Frauenfeld - Spital Thurgau AG

Frauenfeld, Thurgau, 8500, Switzerland

Location

Kantonsspital Münsterlingen - Spital Thurgau AG

Münsterlingen, Thurgau, CH8596, Switzerland

Location

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

Location

Chi Mei Medical Center

Tainan, Tainan, 71004, Taiwan

Location

Chi Mei Hospital - Liouying Branch

Tainan, Tainan, 73657, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 112, Taiwan

Location

Taipei Municipal Wan Fang Hospital

Taipei, 116, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

Location

Hacettepe Universite Hastaneleri

Altindağ, Ankara, 06230, Turkey (Türkiye)

Location

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

Istanbul, İ̇stanbul, 34722, Turkey (Türkiye)

Location

Acibadem Altunizade Hospital

Istanbul, İ̇stanbul, 34752, Turkey (Türkiye)

Location

I.E.U. Medical Point Hastanesi

Izmir, İ̇zmir, 35575, Turkey (Türkiye)

Location

Adana Medical Park Seyhan Hastanesi

Adana, 01140, Turkey (Türkiye)

Location

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, 01370, Turkey (Türkiye)

Location

Gulhane Egitim Arastirma Hastanesi

Ankara, 06010, Turkey (Türkiye)

Location

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

Location

Akdeniz Universitesi Hastanesi

Antalya, 07059, Turkey (Türkiye)

Location

Trakya University Medical Faculty Hospital

Edirne, 22030, Turkey (Türkiye)

Location

Samsun Medical Park Hastanesi

Samsun, 55200, Turkey (Türkiye)

Location

St Bartholomew's Hospital

London, London, CITY of, EC1A 7BE, United Kingdom

Location

Royal Blackburn Hospital

Blackburn, BB2 3HH, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

The Christie Hospital NHS Foundation Trust

Manchester, M20 4GJ, United Kingdom

Location

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer Inc.

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

December 16, 2022

Study Start

March 3, 2023

Primary Completion

January 31, 2025

Study Completion (Estimated)

May 15, 2028

Last Updated

March 18, 2026

Results First Posted

February 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

More information

Locations