AzTrials
AzTrials

Estrogen Receptor-Positive, HER2-Negative Advanced Breast CancerPhase 3NCT06065748

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

A Phase 3 study testing Giredestrant, Fulvestrant and Abemaciclib in people with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer, run by Hoffmann-La Roche at 311 sites in 37 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Giredestrant, Fulvestrant and Abemaciclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,050 participants
Where
311 sitesin 37 countries
Study dates
11 Dec 2023to 12 Feb 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
  • Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
  • Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
  • Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after >/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred >/=12 months since completion).
  • No prior systemic anti-cancer therapy for advanced disease
  • Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
  • For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment

Who cannot join

  • Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
  • Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
  • Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
  • Active cardiac disease or history of cardiac dysfunction
  • Clinically significant history of liver disease

Trial locations and contacts

311 sites in 37 countries.

311 sites in 37 countries

United States40 sites

  • AdventHealth Altamonte

    Altamonte Springs, Florida, 32701

  • Maryland Oncology Hematology

    Annapolis, Maryland, 21401

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30329

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Alliance Cancer Specialists

    Bensalem, Pennsylvania, 19020

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Southern Cancer Center

    Daphne, Alabama, 36526

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Astera Cancer Care East Brunswick

    East Brunswick, New Jersey, 08816

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists - Broadway

    Fort Myers, Florida, 33901

  • West Cancer Center

    Germantown, Tennessee, 38138

  • Oncology Hematology West - Grand Island

    Grand Island, Nebraska, 68803

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

  • Kaiser Permanente - Harbor City

    Harbor City, California, 90710

  • Texas Oncology - DFW

    Irving, Texas, 75063

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • HCA Midwest Division

    Kansas City, Missouri, 64132

  • Ann B. Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17604

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120-4413

  • Oncura Health

    Los Angeles, California, 90017

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504-8332

  • West Virginia University Hospitals Inc

    Morgantown, West Virginia, 26056

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Oncology Hematology West - Legacy

    Omaha, Nebraska, 68130-2042

  • Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit

    Philadelphia, Pennsylvania, 19106

  • Brown University Health

    Providence, Rhode Island, 02905

  • Duke Women Cancer Care

    Raleigh, North Carolina, 27607

  • Virginia Commonwealth University - Massey Cancer Center

    Richmond, Virginia, 23219

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)

    St. Petersburg, Florida, 33701-4553

  • Comprehensive Hematology Oncology

    St. Petersburg, Florida, 33709

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente

    Torrance, California, 90502

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hosp Center

    Washington D.C., District of Columbia, 20010

  • Florida Cancer Specialists - EAST - SCRI - PPDS

    West Palm Beach, Florida, 33401-3406

Other trials in United States

China27 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • the First Hospital of Jilin University

    Changchun, 130021

  • Hunan Cancer Hospital

    Changsha, 410013

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • No. 900 Hospital (Fuzhou General Hospital)

    Fuzhou, 350009

  • Cancer Center, Sun Yat-sen University of Medical Sciences

    Guangzhou, 510060

  • The Second Affiliated Hospital of Zhejiang University College

    Hangzhou, 310009

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Jinan Central Hospital

    Jinan, 250013

  • Shandong Cancer Hospital

    Jinan, 250117

  • The First People's Hospital of Yunnan Province

    Kunming, 650034

  • The First Affiliated Hospital to Henan University of Science and Technology

    Luoyang, 471031

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Shanxi Province Cancer Hospital

    Taiyuan, 030013

  • Tianjin Cancer Hospital

    Tianjin

  • The Tumor Hospital of Xinjiang Medical University

    Ürümqi, 830000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022

  • Hubei Cancer Hospital

    Wuhan, 430079

  • The Second Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, 710004

  • Xi'an International Medical Center Hospital

    Xi'an, 710100

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

Italy21 sites

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

    Avellino, Campania, 83100

  • RCCS - Centro di Riferimento

    Aviano (PN), Friuli Venezia Giulia, 33081

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

  • Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25123

  • Presidio Ospedaliero di Summa-Perrino

    Brindisi, Apulia, 72100

  • Asst Di Cremona

    Cremona, Lombardy, 26100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

  • I.R.S.T Srl IRCCS

    Meldola, Emilia-Romagna, 47014

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

  • Humanitas Centro Catanese Di Oncologia

    Misterbianco (CT), Sicily, 95045

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131

  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE

    Naples, Campania, 80131

  • A.O.U. Maggiore della Carità

    Novara, Piedmont, 28100

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128

  • A.O. Universitaria Di Parma

    Parma, Emilia-Romagna, 43100

  • Ospedale Di Macerata

    Province of Macerata, The Marches, 62100

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

  • Università Campus Bio-Medico di Roma

    Rome, Lazio, 128

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

  • A.O. Universitaria S. Maria Della Misericordia Di Udine

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Brazil20 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Hospital Sírio-Libanês

    Brasília, Federal District, 70200-730

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-232

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Hospital do Câncer de Londrina

    Londrina, Paraná, 86015-520

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-000

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000

  • Instituto D'Or de Pesquisa e Ensino

    Rio de Janeiro, 22281-100

  • Obras Sociais Irma Dulce - Osid

    Salvador, Estado de Bahia, 40415-006

  • Hospital Sao Domingos

    São Luís, Maranhão, 65060-645

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050

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

    São Paulo, São Paulo, 01317-001

  • Hospital A. C. Camargo

    São Paulo, São Paulo, 01509-010

  • Vencer Oncoclínica - Centro de Pesquisa do Piauí

    Teresina, Piauí, 64049-200

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Canada15 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

    Chicoutimi, Quebec, G7H 5H6

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CISSS Chaudière-Appalaches

    Lévis, Quebec, G6V 3Z1

  • Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

    Mississauga, Ontario, L5M 2N1

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0C2

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • CHU de Québec - Hôpital du Saint-Sacrement

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Hopital regional de saint jerome

    Saint-Jérôme, Quebec, J7Z 5T3

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, SK S7N 4H4

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

  • North York General Hospital

    Toronto, Ontario, M2K 1E1

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

  • Centre hospitalier regional de Trois-Rivieres

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Spain15 sites

  • Institut Catala d?Oncologia Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitari Dexeus - Grupo Quironsalud

    Barcelona, 08028

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Virgen de La Arrixaca

    EL Palmar (EL Palmar), Murcia, 30120

  • Hospital Juan Ramon Jimenez

    Huelva, 21005

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

    Jaén, 23007

  • Hospital de Jerez de la Frontera

    Jerez de la Frontera, Cadiz, 11407

  • Centro Oncologico MD Anderson Internacional

    Madrid, 28033

  • Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Instituto Valenciano Oncologia

    Valencia, 46009

  • Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

    Valencia, 46015

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36213

Other trials in Spain

France13 sites

  • ICO Paul Papin

    Angers, 49055

  • Institut Sainte Catherine

    Avignon, 84918

  • Hopital Jean Minjoz

    Besançon, 25030

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Hospitalier Saint Louis

    La Rochelle, 17019

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Centre Cancerologie Grand Montpellier

    Montpellier, 34070

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35042

  • IUCT Oncopole

    Toulouse, 31100

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Poland11 sites

  • Instytut "Centrum Zdrowia Matki Polki"

    ?ód?, 93-338

  • Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

    Bydgoszcz, 85-796

  • Szpital Morski Im. Pck

    Gdynia, 81-519

  • Narodowy Instytut Onkologii Odzia? w Gliwicach

    Gliwice, 44-102

  • ?wi?tokrzyskie Centrum Onkologii

    Kielce, 25-734

  • Przychodnia Lekarska KOMED, Roman Karaszewski

    Konin, 62-500

  • Szpital Wojewódzki im. Miko?aja Kopernika

    Koszalin, 75-581

  • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

    Lublin, 20-090

  • Mazowiecki Szpital Wojewódzki im. ?w. Jana Paw?a II

    Siedlce, 08-110

  • Zachodniopomorskie Centrum Onkologii

    Szczecin, 71-730

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

    Warsaw, 02-781

Other trials in Poland

Germany10 sites

  • Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie

    Bamberg, 96049

  • St. Elisabeth Krankenhaus Köln GmbH

    Cologne, 50935

  • Gynonco Düsseldorf, MVZ Medical Center GmbH

    Düsseldorf, 40235

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Kliniken Essen-Mitte

    Essen, 45136

  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Freiburg im Breisgau, 79110

  • Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66424

  • Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

    Mönchengladbach, 41061

  • Rotkreuzklinikum München

    München, 80637

Other trials in Germany

South Korea10 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Ewha Womans University Mokdong Hospital

    Seoul, 07985

  • Samsung Medical Center

    Seoul, 135-710

  • Ulsan University Hosiptal

    Ulsan, 44033

Other trials in South Korea

Argentina9 sites

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

    Buenos Aires, C1113AAE

  • Inst. de Oncologia Angel H. Roffo

    Buenos Aires, C1417DTB

  • Centro Oncologico Korben

    Ciudad Autonoma Buenos Aires, C1426AGE

  • Sanatorio Allende

    Córdoba, X5000JHQ

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Hospital Alemán

    Recoleta, C1118AAT

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

  • Hospital Provincial del Centenario

    Rosario, S2002KDS

  • Centro Oncológico de Excelencia

    San Juan, J5400

Other trials in Argentina

Mexico9 sites

  • Panamerican Clinical Research S.A de C.V.

    Guadalajara, Jalisco, 44670

  • RENATI INNOVATION S.A.P.I. de C.V

    Guadalajara, Jalisco, 44680

  • Productos y Servicios Oncologicos Acacias SA de CV

    Mexico City, Mexico CITY (federal District), 03240

  • Centro de Atencion Oncologica Viva S de RL de CV

    Mexico City, Mexico CITY (federal District), 06760

  • CENEIT Oncologicos

    Mexico City, 03100

  • Clinica Alivia sucursal Coyoacan

    Mexico City, 04010

  • Hospital Zambrano Hellion TecSalud

    Monterrey, Nuevo León

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020

  • PanAmerican Clinical Research, Querétaro

    Queréaro, Querétaro, 76230

Other trials in Mexico

Peru9 sites

  • Centro Medico Monte Carmelo

    Arequipa, 04001

  • Hospital Goyeneche

    Arequipa, 5154

  • Clínica Santa Beatriz

    Lima, 15072

  • Hospital Nacional Arzobispo Loayza

    Lima, 1

  • Oncosalud Sac

    Lima, 41

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

  • Clinica Internacional, Sede San Borja

    Lima, Lima 41

  • Instituto Peruano de Oncología y Radioterapia

    Lima

  • Clinica San Antonio;Investigaciones Trujillo S.A.C.

    Trujillo, 13008

Other trials in Peru

Australia8 sites

  • Cancer Research SA

    Adelaide, South Australia

  • Sunshine Coast Haematology and Oncology Clinic

    Buderim, Queensland, 4556

  • Northern Beaches Hospital

    Frenchs Forest, New South Wales, 2086

  • Barwon Health

    Geelong, Victoria, 3220

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Mater Hospital

    North Sydney, New South Wales, 2060

  • Mater Misericordiae Limited

    South Brisbane, Queensland, 4101

  • Sunshine Hospital

    St Albans, Victoria, 3021

Other trials in Australia

Turkey (Türkiye)8 sites

  • Sakarya Training and Research Hospital

    Adapazarı, 54290

  • Ankara City Hospital

    Ankara, 06800

  • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

    Bakirkoy / Istanbul, 34147

  • Izmir Ataturk Training and Research Hospital

    Izmir, 35360

  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital

    Kadiköy, 34722

  • Mersin City Education and Research Hospital

    Mersin, 33240

  • Medikal Park Samsun

    Samsun, 55200

  • Hacettepe Uni Medical Faculty Hospital

    Sihhiye/Ankara, 06230

Other trials in Turkey (Türkiye)

Chile7 sites

  • Hospital las Higueras

    Concepción, Región Bio Bio, Alto Horno 777

  • Medicina de Precisión - Celerity

    Las Condes, 7560908

  • Clínica Puerto Montt

    Port Montt, 5500243

  • Oncovida

    Providencia, 750000

  • Centro De Cancer Universidad Catolica

    Santiago, 8330032

  • Instituto Nacional del Cancer

    Santiago, 8380000

  • Icegclinic

    Santiago

Other trials in Chile

Guatemala7 sites

  • Oncomedica

    Guatemala City, 01009

  • Celan S.A.

    Guatemala City, 01010

  • INTEGRA Cancer Institute

    Guatemala City, 01010

  • Onco Go, S.A.

    Guatemala City, 01010

  • Grupo Angeles

    Guatemala City, 01015

  • Medi-k

    Guatemala City, 01016

  • Centro Medico Integral de Cancerologia CEMIC

    Salcajá, 09002

Other trials in Guatemala

India7 sites

  • HealthCare Global Enterprises Limited

    Banglore, Karnataka, 560027

  • MVR Cancer Centre and Research Institute

    Kozhikode, Kerala, 673601

  • Sir H. N. Reliance Foundation Hospital and Research Centre

    Mumbai, Maharashtra, 400004

  • Grant Medical Foundation, Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra, 411004

  • Sunact Cancer Institute

    Thane, Maharashtra, 400615

  • Regional Cancer Centre

    Trivandrum, Kerala, 695011

Other trials in India

Belgium6 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU de Liège (Sart Tilman)

    Liège, 4000

  • Clinique Ste-Elisabeth

    Namur, 5000

  • ZAS Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

Taiwan6 sites

  • Hsin-Chu Branch of National Taiwan University Hospital

    Hsinchu, 300

  • China Medical University Hospital

    Taichung, 404

  • Veterans General Hospital

    Taipei, 00112

  • National Taiwan Uni Hospital

    Taipei, 100

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 11259

  • Veterans General Hospital - Taichung

    Xitun Dist., 40705

Other trials in Taiwan

Thailand6 sites

  • Chulalongkorn Hospital

    Bangkok, 10330

  • National Cancer Institute

    Bangkok, 10400

  • Rajavithi Hospital

    Bangkok, 10400

  • Chulabhorn Hospital

    Lak Si, 10210

  • Maharaj Nakorn Chiang Mai Hospital;Depart of Radiology

    Muang Chiang MAI Delivery Branch 3, 50200

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Colombia5 sites

  • Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

    Bogotá D.C., 51000

  • Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

    Bogota, D.C., 110131

  • IPS Salud SURA Chipichape Cali

    Cali

  • Oncomedica S.A.

    Montería, 230002

  • Sociedad de Oncología y hematología del Cesar Ltda

    Valledupar, 200001

Other trials in Colombia

Greece5 sites

  • Anticancer Hospital Ag. Savas

    Athens, 115 22

  • Aretaieio Hospital of Athens

    Athens, 115 28

  • University Hospital of Larissa

    Larissa, 411 10

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

  • European Interbalkan Medical Center

    Thessaloniki, 570 01

Other trials in Greece

Portugal5 sites

  • IPO de Coimbra

    Coimbra, 3000-075

  • Hospital de S. Francisco Xavier

    Lisbon, 1495-005

  • Hospital da Luz

    Lisbon, 1500-650

  • IPO do Porto

    Porto, 4200-072

  • CHVNG/E_Unidade 1

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Romania5 sites

  • Spitalul Clinic Filantropia

    Bucharest, 011171

  • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu

    Bucharest, 022328

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

    Cluj-Napoca, 400015

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Centrul de Oncologie Oncohelp

    Timișoara, 300239

Other trials in Romania

Hungary4 sites

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Bács-Kiskun Vármegyei Oktatókórház

    Kecskemét, 6000

  • B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház

    Miskolc, 3526

  • Nograd Varmegyei Szent Lazar Korhaz

    Salgótarján, 3100

Other trials in Hungary

Israel4 sites

  • Hadassah Ein Karem Hospital

    Jerusalem, 9112000

  • Rabin Medical Center

    Petah Tikva, 4910000

  • Sheba MC

    Ramat Gan, 5265601

  • Sourasky Medical Center

    Tel Aviv, 6423900

Other trials in Israel

Austria3 sites

  • Lkh-Univ. Klinikum Graz

    Graz, 8036

  • Ordensklinikum Linz Barmherzige Schwestern

    Linz, 4010

  • Oö. Gesundheits- und Spitals-AG/LKH Steyr

    Steyr, 4400

Other trials in Austria

New Zealand3 sites

  • Christchurch Hospital

    Christchurch

  • Palmerston North Hospital

    Palmerston North, 4442

  • Whangarei Hospital

    Whangarei, 0110

Other trials in New Zealand

South Africa3 sites

  • Cancercare

    Port Elizabeth, 6045

  • Steve Biko Academic Hospital

    Pretoria, 0002

  • Wits Clinical Research

    Soweto, 2013

Other trials in South Africa

Costa Rica2 sites

  • Clinica CIMCA

    San José, 10103

  • ICIMED Instituto de Investigación en Ciencias Médicas

    San José, 10108

Other trials in Costa Rica

Hong Kong2 sites

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • National Cancer Centre

    Singapore, 168583

Other trials in Singapore

Finland1 site

  • Tampere University Hospital

    Tampere, 33520

Other trials in Finland

Kenya1 site

  • University of Nairobi - Institute of Tropical and Infectious Diseases

    Nairobi

Other trials in Kenya

Puerto Rico1 site

  • PanOncology Trials

    San Juan, 00935

Other trials in Puerto Rico

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Being tested
Giredestrant, Fulvestrant, Abemaciclib, Palbociclib, Ribociclib
Keywords
oral Selective Estrogen Receptor Degrader (SERD), CDK4/6 inhibitor (CDK4/6i), ESR1 mutation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GiredestrantDrug

    Also called RO7197597, RG6171, GDC-9545

    Giredestrant 30 milligrams (mg) orally (PO) once a day (QD) on Days 1-28 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.

  • FulvestrantDrug

    Fulvestrant 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle until PD or unacceptable toxicity.

  • AbemaciclibDrug

    If chosen by the investigator as the CDK4/6i, participants will receive abemaciclib 150 mg PO twice per day (BID) on Days 1-28 of each 28-day cycle until PD or unacceptable toxicity.

  • PalbociclibDrug

    If chosen by the investigator as the CDK4/6i, participants will receive palbociclib 125 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

  • RibociclibDrug

    If chosen by the investigator as the CDK4/6i, participants will receive ribociclib 600 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

  • LHRH AgonistDrug

    Only pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each 28-day treatment cycle.

  • FoundationOne Liquid CDx Assay (F1LCDx)Diagnostic test

    Also called F1LCDx

    F1LCDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that detects and analyses genomic alterations in circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of cancer patients. It will be used to determine the eligibility of participants requiring confirmation of ESR1 mutation status (mutation detected [ESR1m] vs. no mutation detected [ESR1nmd]).

Study groups in NCT06065748
Study groupRoleWhat they receive
Giredestrant + Investigator's Choice of CDK4/6iExperimentalParticipants in the experimental arm will receive giredestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.
Receives: Drug: Giredestrant; Drug: Abemaciclib; Drug: Palbociclib; Drug: Ribociclib; Drug: LHRH Agonist; Diagnostic Test: FoundationOne Liquid CDx Assay (F1LCDx)
Fulvestrant + Investigator's Choice of CDK4/6iActive comparatorParticipants in the control arm will receive fulvestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.
Receives: Drug: Fulvestrant; Drug: Abemaciclib; Drug: Palbociclib; Drug: Ribociclib; Drug: LHRH Agonist; Diagnostic Test: FoundationOne Liquid CDx Assay (F1LCDx)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup

    PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study.

    Measured: From randomization to first occurrence of progressive disease (PD) or death (up to 5 years)

  2. PFS in the Full Analysis Set (FAS) Population

    Measured: From randomization to first occurrence of PD or death (up to 5 years)

Secondary outcomes (14)

  1. PFS in the ESR1 no-mutation-detected (ESR1nmd) Subgroup

    Measured: From randomization to first occurrence of PD or death (up to 5 years)

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death from any cause. It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.

    Measured: From randomization until death from any cause (up to 5 years)

  3. Confirmed Objective Response Rate (cORR)

    The cORR is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart, as determined by the investigator according to RECIST v1.1. It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.

    Measured: From randomization until treatment discontinuation (up to 5 years)

  4. Duration of Response (DOR)

    DOR is defined as the time from the first occurrence of a documented objective response to PD, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first). It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.

    Measured: From the first occurrence of a documented objective response to PD or death (up to 5 years)

  5. Clinical Benefit Rate (CBR)

    The CBR is defined as the percentage of participants with stable disease for at least (≥)24 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1. It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.

    Measured: From randomization until treatment discontinuation (up to 5 years)

  6. Time to Chemotherapy

    Time to chemotherapy is defined as the time from randomization until the start date of the first chemotherapy or death from any cause (whichever occurs first). It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.

    Measured: From randomization until the start of chemotherapy or death (up to 5 years)

  7. Time to Confirmed Deterioration (TTCD) in Pain Severity

    TTCD in pain severity is defined as the time from randomization to the first documentation of ≥2-point increase from baseline on the "worst pain" item score of the Brief Pain Inventory-Short Form (BPI-SF). It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.

    Measured: From randomization until end of follow-up (up to 5 years)

  8. TTCD in Pain Presence and Interference

    TTCD in pain presence and interference is defined as the time from randomization to the first documentation of ≥10-point increase in pain score, as determined using the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) questionnaire. It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.

    Measured: From randomization until end of follow-up (up to 5 years)

  9. TTCD in Physical Functioning

    TTCD in physical functioning (PF) is defined as the time from randomization to the first documentation of ≥10-point decrease in PF score, as determined using the EORTC QLQ-C30 questionnaire. It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.

    Measured: From randomization until end of follow-up (up to 5 years)

  10. TTCD in Role Functioning

    TTCD in role functioning (RF) is defined as the time from randomization to the first documentation of ≥10-point decrease in RF score, as determined using the EORTC QLQ-C30 questionnaire. It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.

    Measured: From randomization until end of follow-up (up to 5 years)

  11. TTCD in Global Health Status/Quality of Life

    TTCD in in Global Health Status/Quality of Life (GHS/QoL) is defined as the time from randomization to the first documentation of ≥10-point decrease in GHS/QoL score, as determined using the EORTC QLQ-C30 questionnaire. It will be analyzed in the FAS and in the ESR1m and ESR1nmd subgroups.

    Measured: From randomization until end of follow-up (up to 5 years)

  12. Incidence and Severity of Adverse Events

    Incidence will be reported as the number of participants with at least one adverse event, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0).

    Measured: From Baseline until 28 days after the final dose of study treatment (up to 5 years)

  13. Number of Participants with Vital Sign Abnormalities Over the Course of the Study

    Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature.

    Measured: From Baseline until 28 days after the final dose of study treatment (up to 5 years)

  14. Number of Participants with Clinical Laboratory Test Abnormalities for Hematology and Biochemistry Parameters Over the Course of the Study

    Measured: From Baseline until 28 days after the final dose of study treatment (up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2023
  2. Study start11 Dec 2023
  3. Primary completion20 Apr 2028 (estimated)
  4. Study completion12 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,050 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06065748
Sponsor's protocol ID
CO44657
Other IDs
2022-502980-39-00
Status last verified
Sep 2026
First submitted
26 Sep 2023
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Giredestrant, Fulvestrant and Abemaciclib in people with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer, run by Hoffmann-La Roche at 311 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 311 sites in United States, China, Italy, Brazil, Canada and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup (time frame: From randomization to first occurrence of progressive disease (PD) or death (up to 5 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06065748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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