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ACTIVE NOT RECRUITING
NCT04546009
PHASE3

A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

Official title: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

992

Start Date

2020-10-09

Completion Date

2028-03-25

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

Giredestrant

Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

DRUG

Giredestrant-matched Placebo

Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

DRUG

Letrozole

Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

DRUG

Letrozole-matched Placebo

Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

DRUG

Palbociclib

Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.

DRUG

LHRH Agonist

Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Locations (256)

Orange Coast Memorial Medical Center

Fountain Valley, California, United States

Long Beach Memorial Medical Center

Long Beach, California, United States

Kaiser Permanente - San Leandro Medical Center

San Leandro, California, United States

Stanford Univ Medical Center

Stanford, California, United States

Kaiser Permanente - Walnut Creek

Walnut Creek, California, United States

University of Colorado

Aurora, Colorado, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Florida Cancer Specialists - Fort Myers (Broadway)

Fort Myers, Florida, United States

Memorial Regional Cancer Ctr

Hollywood, Florida, United States

University of Miami

Miami, Florida, United States

SCRI Florida Cancer Specialists North

St. Petersburg, Florida, United States

SCRI Florida Cancer Specialists PAN

Tallahassee, Florida, United States

Kaiser Permanente - Moanalua Medical Center

Honolulu, Hawaii, United States

Mercy Medical Center

Baltimore, Maryland, United States

Maryland Oncology Hematology

Silver Spring, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

HCA Midwest Division

Kansas City, Missouri, United States

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, United States

Astera Cancer Care East Brunswick

East Brunswick, New Jersey, United States

Memorial Sloan Kettering Cancer Center at Bergen

Montvale, New Jersey, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

MSKCC @ Commack

Commack, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Providence Portland Medical Ctr

Portland, Oregon, United States

Roper St. Francis Healthcare

Charleston, South Carolina, United States

West Cancer Center

Germantown, Tennessee, United States

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology - DFW

Dallas, Texas, United States

The Center for Cancer and Blood Disorders - Fort Worth

Fort Worth, Texas, United States

Baylor St. Luke's Medical Center

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Inova Fairfax Hospital

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Northwest Medical Specialties

Tacoma, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Hospital de Onc Angel Roffo

Buenos Aires, Argentina

Organización medica de Investi

Cap Fed, Argentina

Hospital Britanico

Ciudad Autonoma Bs As, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

CEMER Centro Medico de Enfermedades Respiratorias

Vicente López, Argentina

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Peter MacCallum Cancer Centre-East Melbourne

Melbourne, Victoria, Australia

Sunshine Hospital

St Albans, Victoria, Australia

Fiona Stanley Hospital - Medical Oncology

Murdoch, Western Australia, Australia

Uniklinikum Salzburg, LKH

Salzburg, Austria

A.Ö. LHK

Steyr, Austria

Medizinische Universität Wien

Vienna, Austria

Cliniques Universitaires St-Luc

Brussels, Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, Belgium

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, Brazil

Hospital Araujo Jorge

Goiânia, Goiás, Brazil

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

São Paulo, São Paulo, Brazil

Beneficencia Portuguesa de Sao Paulo

São Paulo, São Paulo, Brazil

Arthur J.E. Child Comprehensive Cancer Center-Calgary

Calgary, Alberta, Canada

BC Cancer ? Surrey

Surrey, British Columbia, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

William Osler Health System Brampton Civic Hospital

Brampton, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Universite de Montreal - Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Centre Hospitalier de l?Université de Montréal (CHUM)

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

McGill University Health Center

Montreal, Quebec, Canada

Hopital du Saint Sacrement

Québec, Quebec, Canada

Anyang Tumor Hosptial

Anyang, China

Affiliated Hospital of Hebei University

Baoding, China

Beijing Cancer Hospital

Beijing, China

the First Affiliated Hospital of Bengbu Medical College

Bengbu, China

The First Hospital of Jilin University

Changchun, China

Hunan Cancer Hospital

Changsha, China

Fujian Medical University Union Hospital

Fujian, China

Sun Yat-sen Memorial Hospital

Guangzhou, China

Sun Yet-sen University Cancer Center

Guangzhou, China

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Shandong Cancer Hospital

Jinan, China

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, China

Shengjing Hospital of China Medical University

Shenyang, China

Liaoning cancer Hospital & Institute

Shenyang, China

The First Affiliated Hospital of Xian Jiao Tong University

Xi'an, China

Herlev Hospital

Herlev, Denmark

Sjællands Universitetshospital, Næstved

Næstved, Denmark

Odense Universitetshospital, Onkologisk Afdeling R

Odense C, Denmark

ICO Paul Papin

Angers, France

Centre Hospitalier de La Cote Basque

Bayonne, France

Chd de Vendee

La Roche-sur-Yon, France

Institut régional du Cancer Montpellier

Montpellier, France

Chu La Miletrie

Poitiers, France

Institut Jean Godinot

Reims, France

Centre Eugene Marquis

Rennes, France

ICL

Saint-Priest-en-Jarez, France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, France

Ambulantes Tumorzentrum Spandau

Berlin, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, Germany

Universitätsklinikum Essen

Essen, Germany

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

Georgsmarienhütte, Germany

Dres.Andreas Ammon und Dirk Meyer

Göttingen, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Facharztzentrum Eppendorf, Studien GbR

Hamburg, Germany

Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

Hanover, Germany

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, Germany

Praxis Köppler, Heymann, Weide, Thomalla

Koblenz, Germany

Dres. Andreas Köhler und Roswitha Fuchs

Langen, Germany

St. Elisabeth-Krankenhaus, Senologie/Brustzentrum

Leipzig, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

München, Germany

MVZ für Hämatologie und Onkologie Ravensburg GmBH

Ravensburg, Germany

Klinikum Mutterhaus der Borromaeerinnen gGmbH

Trier, Germany

Dres. Helmut Forstbauer, Carsten Ziske und Kollegen

Troisdorf, Germany

Universitätsklinik Tübingen

Tübingen, Germany

Anticancer Hospital Ag Savas

Athens, Greece

Anticancer Hospital Ag. Savas

Athens, Greece

Euromedical General Clinic of Thessaloniki

Thessaloniki, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Princess Margaret Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Honvédelmi Minisztérium Állami Egészségügyi Központ;Onkológiai Osztály

Budapest, Hungary

Budapesti Uzsoki Utcai Kórház

Budapest, Hungary

Davidof Center - Rabin Medical Center

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Ctr

Tel Aviv, Israel

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

Meldola, Emilia-Romagna, Italy

IRCCS Istituto Regina Elena (IFO)

Rome, Lazio, Italy

Az. Osp. Spedali Civili

Brescia, Lombardy, Italy

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Asst Di Monza

Monza, Lombardy, Italy

Humanitas Centro Catanese Di Oncologia

Misterbianco (CT), Sicily, Italy

Fondazione del Piemonte per l?Oncologia (IRCCS)

Candiolo, Trentino-Alto Adige, Italy

Ospedale Civile - Livorno

Livorno, Tuscany, Italy

Ospedale Sacro Cuore Don Calabria

Negrar, Veneto, Italy

IOV - Istituto Oncologico Veneto - IRCCS

Padova, Veneto, Italy

Azienda ULSS 8 Berica

Vicenza, Veneto, Italy

Nagoya University Hospital

Aichi, Japan

Chiba Cancer Center

Chiba, Japan

National Cancer Center Hospital East

Chiba, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Japan

Hiroshima University Hospital

Hiroshima, Japan

National Hospital Organization Hokkaido Cancer Center

Hokkaido, Japan

Hyogo Cancer Center

Hyōgo, Japan

University of Tsukuba Hospital

Ibaraki, Japan

Sagara Hospital

Kagoshima, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Tokai University Hospital

Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Japan

Fukushima Medical University Hospital

Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Naha-nishi Clinic

Okinawa, Japan

National Hospital Organization Osaka National Hospital

Osaka, Japan

Osaka International Cancer Institute

Osaka, Japan

Saitama Cancer Center

Saitama, Japan

National Cancer Center Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Showa Medical University Hospital

Tokyo, Japan

Health Pharma Professional Research

CD Mexico, Mexico CITY (federal District), Mexico

Centro de Atencion Oncologica Viva S de RL de CV

Mexico City, Mexico CITY (federal District), Mexico

Filios Alta Medicina

Monterrey, Nuevo León, Mexico

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Oaxaca, Mexico

Oncologico Potosino

San Luis Potosí City, San Luis Potosí, Mexico

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Morelia, Mexico

Sociedad de Metabolismo y Corazón (SOMECO)

Veracruz, Mexico

Auckland City Hospital

Auckland, New Zealand

Oncosalud Sac

Lima, Peru

Instituto Peruano de Oncología y Radioterapia

Lima, Peru

Instituto Nacional de Enfermedades Neoplasicas

Lima, Peru

Instituto Regional de Enfermedades Neoplasicas - IREN Norte

Trujillo, Peru

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Szpital Morski im. PCK

Gdynia, Poland

Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad

Warsaw, Poland

IPO de Coimbra

Coimbra, Portugal

Hospital da Luz

Lisbon, Portugal

Centro Hospitalar Lisboa Norte

Lisbon, Portugal

IPO do Porto

Porto, Portugal

SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

Moskva, Moscow Oblast, Russia

Podolsk City Clinical Hospital

Podolsk, Moscow Oblast, Russia

Respublikanskiy Onkologicheskiy Dispanser

Saransk, Respublika Mordoviya, Russia

Ryazan Regional clinical oncology dispensary

Ryazan, Ryazan Oblast, Russia

GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

Saint Petersburg, Sankt-Peterburg, Russia

Chelyabinsk region oncology dispensary

Chelyabinsk, Russia

Multidisciplinary clinic Reaviz

Samara, Russia

Regional Clinical Oncology Hospital

Yaroslavl, Russia

Chungbuk National University Hospital

Cheongju-si, South Korea

Kyungpook National University Medical Center

Daegu, South Korea

National Cancer Center

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Ulsan University Hosiptal

Ulsan, South Korea

Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Hospital de Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, Spain

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitari Dexeus - Grupo Quironsalud

Barcelona, Spain

Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Centro Oncologico MD Anderson Internacional

Madrid, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

HM Sanchinarro ? CIOCC

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung Uni Hospital

Tainan, Taiwan

Veterans General Hospital

Taipei, Taiwan

National Taiwan Uni Hospital

Taipei, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Chang Gung Memorial Hosipital at Linkou

Taoyuan Hsien, Taiwan

Chulalongkorn Hospital, Faculty of Medicine

Bangkok, Thailand

Rajavithi Hospital

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hosp

Chang Mai, Thailand

Songklanagarind Hospital

Songkhla, Thailand

Hacettepe Uni Medical Faculty Hospital

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, Turkey (Türkiye)

Medipol University Medical Faculty

Istanbul, Turkey (Türkiye)

Katip Celebi University Ataturk Training and Research Hospital

Izmir, Turkey (Türkiye)

Kocaeli University Faculty of Medicine

İzmit, Turkey (Türkiye)

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Malatya, Turkey (Türkiye)

19 Mayis University Medical Faculty

Samsun, Turkey (Türkiye)

Municipal Institution City Clinical Hospital #4 of Dnipro City Council

Dnipropetrovsk, Katerynoslav Governorate, Ukraine

SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU

Kharkiv, Kharkiv Governorate, Ukraine

Ivano-Frankivsk Regional Oncology Center

Ivano-Frankivsk, Ukraine

ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council

Kryvyi Rih, Ukraine

Sumy Regional Clinical Onc Ctr

Sumy, Ukraine

Royal Sussex County Hospital

Brighton, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

University College London Hospital

London, United Kingdom

Royal Free Hospital

London, United Kingdom

Guys & St Thomas Hospital

London, United Kingdom

Maidstone Hospital

Maidstone, United Kingdom

Peterborough City Hospital

Peterborough, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Royal Marsden Hosp NHS Fnd

Sutton, United Kingdom

Royal Cornwall Hospital

Truro, United Kingdom