AzTrials
AzTrials

Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast CancerPhase 3NCT04546009

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)

A Phase 3 study testing Giredestrant, Letrozole and Palbociclib in people with Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer, run by Hoffmann-La Roche at 255 sites in 30 countries.

Active, not recruiting

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

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Giredestrant, Letrozole and Palbociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
992 participants
Where
255 sitesin 30 countries
Study dates
9 Oct 2020to 31 Jul 2027
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

  • For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
  • Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
  • Documented ER-positive tumor and HER2-negative tumor, assessed locally
  • Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry
  • No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
  • Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
Show all 9Show fewer
  • Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
  • Eastern Cooperative Oncology Group Performance Status 0-1
  • Adequate organ function

Who cannot join

  • Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
  • Prior treatment with a selective estrogen receptor degrader (SERD)
  • Treatment with any investigational therapy within 28 days prior to study treatment
  • Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
  • Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
  • Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
  • Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
  • Pregnant or breastfeeding

Trial locations and contacts

255 sites in 30 countries.

255 sites in 30 countries

United States37 sites

  • University of Colorado

    Aurora, Colorado, 80045-2517

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Memorial Sloan Kettering Cancer Center Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roper St. Francis Healthcare

    Charleston, South Carolina, 29414

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • MSKCC @ Commack

    Commack, New York, 11725

  • Texas Oncology - DFW

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Astera Cancer Care East Brunswick

    East Brunswick, New Jersey, 08816

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22031

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Florida Cancer Specialists - Fort Myers (Broadway)

    Fort Myers, Florida, 33901

  • The Center for Cancer and Blood Disorders - Fort Worth

    Fort Worth, Texas, 76104

  • Orange Coast Memorial Medical Center

    Fountain Valley, California, 92708

  • West Cancer Center

    Germantown, Tennessee, 38138

  • Memorial Regional Cancer Ctr

    Hollywood, Florida, 33021

  • Kaiser Permanente - Moanalua Medical Center

    Honolulu, Hawaii, 96819-1469

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • HCA Midwest Division

    Kansas City, Missouri, 64132

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • University of Miami

    Miami, Florida, 33136

  • Memorial Sloan Kettering Cancer Center at Bergen

    Montvale, New Jersey, 07645

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Providence Portland Medical Ctr

    Portland, Oregon, 97213

  • Kaiser Permanente - San Leandro Medical Center

    San Leandro, California, 94577

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20902

  • SCRI Florida Cancer Specialists North

    St. Petersburg, Florida, 33705

  • Stanford Univ Medical Center

    Stanford, California, 94305

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • SCRI Florida Cancer Specialists PAN

    Tallahassee, Florida, 32308

  • Kaiser Permanente - Walnut Creek

    Walnut Creek, California, 94596

Other trials in United States

Japan22 sites

  • Nagoya University Hospital

    Aichi, 466-8560

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • National Hospital Organization Hokkaido Cancer Center

    Hokkaido, 003-0804

  • Hyogo Cancer Center

    Hyōgo, 673-0021

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • Sagara Hospital

    Kagoshima, 892-0833

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Tokai University Hospital

    Kanagawa, 259-1193

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Fukushima Medical University Hospital

    Miyagi, 960-1295

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Naha-nishi Clinic

    Okinawa, 901-0154

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Saitama Cancer Center

    Saitama, 362-0806

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Showa Medical University Hospital

    Tokyo, 142-8666

Other trials in Japan

Germany19 sites

  • Ambulantes Tumorzentrum Spandau

    Berlin, 13581

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    Dresden, 01307

  • Universitätsklinikum Essen

    Essen, 45122

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

    Georgsmarienhütte, 49124

  • Dres.Andreas Ammon und Dirk Meyer

    Göttingen, 37073

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Facharztzentrum Eppendorf, Studien GbR

    Hamburg, 20249

  • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

    Hanover, 30625

  • Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, 69120

  • Praxis Köppler, Heymann, Weide, Thomalla

    Koblenz, 56068

  • Dres. Andreas Köhler und Roswitha Fuchs

    Langen, 63225

  • St. Elisabeth-Krankenhaus, Senologie/Brustzentrum

    Leipzig, 04277

  • Universitätsklinikum Mannheim

    Mannheim, 68167

  • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

    München, 80336

  • MVZ für Hämatologie und Onkologie Ravensburg GmBH

    Ravensburg, 88212

  • Klinikum Mutterhaus der Borromaeerinnen gGmbH

    Trier, 54290

  • Dres. Helmut Forstbauer, Carsten Ziske und Kollegen

    Troisdorf, 53840

  • Universitätsklinik Tübingen

    Tübingen, 72076

Other trials in Germany

China17 sites

  • Anyang Tumor Hosptial

    Anyang, 455000

  • Affiliated Hospital of Hebei University

    Baoding, 071000

  • Beijing Cancer Hospital

    Beijing, 100142

  • the First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233000

  • The First Hospital of Jilin University

    Changchun, 130021

  • Hunan Cancer Hospital

    Changsha, 410013

  • Fujian Medical University Union Hospital

    Fujian, 350001

  • Sun Yat-sen Memorial Hospital

    Guangzhou, 510000

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Shandong Cancer Hospital

    Jinan, 250117

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • Liaoning cancer Hospital & Institute

    Shenyang, 110042

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an, 710061

Other trials in China

South Korea13 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Kyungpook National University Medical Center

    Daegu, 41944

  • National Cancer Center

    Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Gachon University Gil Medical Center

    Incheon, 21565

  • 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

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 8308

  • Ulsan University Hosiptal

    Ulsan, 44033

Other trials in South Korea

Spain13 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, 15006

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Dexeus - Grupo Quironsalud

    Barcelona, 08028

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

    Barcelona, 08035

  • Hospital de Donostia

    Donostia / San Sebastian, Guipuzcoa, 20080

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Centro Oncologico MD Anderson Internacional

    Madrid, 28033

  • Hospital Ramon y Cajal

    Madrid, 28034

  • HM Sanchinarro ? CIOCC

    Madrid, 28050

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Canada11 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • William Osler Health System Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Arthur J.E. Child Comprehensive Cancer Center-Calgary

    Calgary, Alberta, T2N 5G2

  • Universite de Montreal - Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l?Université de Montréal (CHUM)

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9

  • Hopital du Saint Sacrement

    Québec, Quebec, G1S 4L8

  • BC Cancer ? Surrey

    Surrey, British Columbia, V3V 1Z2

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Italy11 sites

  • Az. Osp. Spedali Civili

    Brescia, Lombardy, 25123

  • Fondazione del Piemonte per l?Oncologia (IRCCS)

    Candiolo, Trentino-Alto Adige, 10060

  • Ospedale Civile - Livorno

    Livorno, Tuscany, 57124

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

    Meldola, Emilia-Romagna, 47014

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Humanitas Centro Catanese Di Oncologia

    Misterbianco (CT), Sicily, 95045

  • Asst Di Monza

    Monza, Lombardy, 20900

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto, 37024

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128

  • IRCCS Istituto Regina Elena (IFO)

    Rome, Lazio, 00144

  • Azienda ULSS 8 Berica

    Vicenza, Veneto, 36100

Other trials in Italy

United Kingdom10 sites

  • Royal Sussex County Hospital

    Brighton, BN2 5BE

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • University College London Hospital

    London, NW1 - 2PG

  • Royal Free Hospital

    London, NW3 2QS

  • Guys & St Thomas Hospital

    London, SE1 9RT

  • Maidstone Hospital

    Maidstone, ME16 0FS

  • Peterborough City Hospital

    Peterborough, PE3 9GZ

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Royal Marsden Hosp NHS Fnd

    Sutton, SM2 5PT

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

Other trials in United Kingdom

France9 sites

  • ICO Paul Papin

    Angers, 49055

  • Centre Hospitalier de La Cote Basque

    Bayonne, 64109

  • Chd de Vendee

    La Roche-sur-Yon, 85925

  • Institut régional du Cancer Montpellier

    Montpellier, 34298

  • Chu La Miletrie

    Poitiers, 86021

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35042

  • ICL

    Saint-Priest-en-Jarez, 42271

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Turkey (Türkiye)9 sites

  • Hacettepe Uni Medical Faculty Hospital

    Ankara, 06100

  • Ankara Bilkent City Hospital

    Ankara, 06490

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

    Edirne, 22030

  • Medipol University Medical Faculty

    Istanbul, 34214

  • Medeniyet University Goztepe Training and Research Hospital.

    Istanbul, 34730

  • Izmir Ataturk Training and Research Hospital

    Izmir, 35360

  • Kocaeli University Faculty of Medicine

    İzmit, 31380

  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

    Malatya, 44280

  • 19 Mayis University Medical Faculty

    Samsun, 55139

Other trials in Turkey (Türkiye)

Brazil8 sites

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

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

    São Paulo, São Paulo, 01317-000

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, São Paulo, 01323-900

Other trials in Brazil

Russia8 sites

  • Chelyabinsk region oncology dispensary

    Chelyabinsk, 454087

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

    Moskva, Moscow Oblast, 111123

  • Podolsk City Clinical Hospital

    Podolsk, Moscow Oblast, 142100

  • Ryazan Regional clinical oncology dispensary

    Ryazan, Ryazan Oblast, 390011

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

    Saint Petersburg, Sankt-Peterburg, 197758

  • Multidisciplinary clinic Reaviz

    Samara, 443011

  • Respublikanskiy Onkologicheskiy Dispanser

    Saransk, Respublika Mordoviya, 430032

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040

Other trials in Russia

Argentina7 sites

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

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE

  • Hospital de Onc Angel Roffo

    Buenos Aires, 1425

  • Organización medica de Investi

    Cap Fed, 1015

  • Hospital Britanico

    Ciudad Autonoma Bs As, C1280AEB

  • Hospital Provincial del Centenario

    Rosario, 2000

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE

  • CEMER Centro Medico de Enfermedades Respiratorias

    Vicente López, B1602DQD

Other trials in Argentina

Mexico7 sites

  • Health Pharma Professional Research

    CD Mexico, Mexico CITY (federal District), 03810

  • Centro de Atencion Oncologica Viva S de RL de CV

    Mexico City, Mexico CITY (federal District), 06760

  • Filios Alta Medicina

    Monterrey, Nuevo León, 64460

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Morelia, 58260

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020

  • Oncologico Potosino

    San Luis Potosí City, San Luis Potosí, 78209

  • Sociedad de Metabolismo y Corazón (SOMECO)

    Veracruz, 91900

Other trials in Mexico

Australia6 sites

  • Peter MacCallum Cancer Centre-East Melbourne

    Melbourne, Victoria, 3000

  • Fiona Stanley Hospital - Medical Oncology

    Murdoch, Western Australia, 6150

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Taiwan6 sites

  • China Medical University Hospital

    Taichung, 404

  • National Cheng Kung Uni Hospital

    Tainan, 704

  • Veterans General Hospital

    Taipei, 00112

  • National Taiwan Uni Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 104

  • Chang Gung Memorial Hosipital at Linkou

    Taoyuan Hsien, 333

Other trials in Taiwan

Thailand5 sites

  • Chulalongkorn Hospital, Faculty of Medicine

    Bangkok, 10330

  • Rajavithi Hospital

    Bangkok, 10400

  • Ramathibodi Hospital

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hosp

    Chang Mai, 50200

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Ukraine5 sites

  • Municipal Institution City Clinical Hospital #4 of Dnipro City Council

    Dnipropetrovsk, Katerynoslav Governorate, 49102

  • Ivano-Frankivsk Regional Oncology Center

    Ivano-Frankivsk, 76018

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

    Kharkiv, Kharkiv Governorate, 61018

  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council

    Kryvyi Rih, 50048

  • Sumy Regional Clinical Onc Ctr

    Sumy, 40005

Other trials in Ukraine

Greece4 sites

  • Anticancer Hospital Ag Savas

    Athens, 115 22

  • Anticancer Hospital Ag. Savas

    Athens, 115 22

  • Euromedical General Clinic of Thessaloniki

    Thessaloniki, 546450

  • European Interbalkan Medical Center

    Thessaloniki, 570 01

Other trials in Greece

Peru4 sites

  • Oncosalud Sac

    Lima, 41

  • Instituto Peruano de Oncología y Radioterapia

    Lima, Lima 27

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

  • Instituto Regional de Enfermedades Neoplasicas - IREN Norte

    Trujillo, 13014

Other trials in Peru

Portugal4 sites

  • IPO de Coimbra

    Coimbra, 3000-075

  • Hospital da Luz

    Lisbon, 1500-650

  • Centro Hospitalar Lisboa Norte

    Lisbon

  • IPO do Porto

    Porto, 4200-072

Other trials in Portugal

Austria3 sites

  • Uniklinikum Salzburg, LKH

    Salzburg, 5020

  • A.Ö. LHK

    Steyr, 4400

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Denmark3 sites

  • Herlev Hospital

    Herlev, 2730

  • Sjællands Universitetshospital, Næstved

    Næstved, 4700

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000

Other trials in Denmark

Hong Kong3 sites

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • Princess Margaret Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Israel3 sites

  • Davidof Center - Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 52620-00

  • Tel Aviv Sourasky Medical Ctr

    Tel Aviv, 6423906

Other trials in Israel

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214

  • Szpital Morski im. PCK

    Gdynia, 81-519

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

    Warsaw, 02-781

Other trials in Poland

Belgium2 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

Other trials in Belgium

Hungary2 sites

  • Honvédelmi Minisztérium Állami Egészségügyi Központ;Onkológiai Osztály

    Budapest, 1062

  • Budapesti Uzsoki Utcai Kórház

    Budapest, 1145

Other trials in Hungary

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

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

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.

Being tested
Giredestrant, Giredestrant-matched Placebo, Letrozole, Letrozole-matched Placebo, Palbociclib
Medical subject headings
Breast Neoplasms

What participants receive

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

  • GiredestrantDrug

    Also called GDC-9545, RO7197597, RG6171

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

  • Giredestrant-matched PlaceboDrug

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

  • LetrozoleDrug

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

  • Letrozole-matched PlaceboDrug

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

  • PalbociclibDrug

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

  • LHRH AgonistDrug

    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.

Study groups in NCT04546009
Study groupRoleWhat they receive
Giredestrant + Letrozole-matched Placebo + PalbociclibExperimentalNot described
Receives: Drug: Giredestrant; Drug: Letrozole-matched Placebo; Drug: Palbociclib; Drug: LHRH Agonist
Letrozole + Giredestrant-matched Placebo + PalbociclibActive comparatorNot described
Receives: Drug: Giredestrant-matched Placebo; Drug: Letrozole; Drug: Palbociclib; Drug: LHRH Agonist

What is being measured

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

  1. Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1

    Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months)

Secondary outcomes (13)

  1. Overall Survival

    Measured: From randomization to death from any cause (up to 78 months)

  2. Objective Response Rate, as Determined by the Investigator According to RECIST v1.1

    The objective response rate is defined as the percentage of participants with a complete response or partial response on two consecutive occasions at least (≥)4 weeks apart.

    Measured: From randomization until disease progression or death (up to 78 months)

  3. Duration of Response, as Determined by the Investigator According to RECIST v1.1

    Measured: From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months)

  4. Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1

    The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response or partial response.

    Measured: From randomization until disease progression or death (up to 78 months)

  5. Time to Confirmed Deterioration in Pain Level, Defined as the Time to First Documented ≥2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire

    Measured: From Baseline until treatment discontinuation (up to 78 months)

  6. Time to Confirmed Deterioration in Pain Presence and Interference, Defined as the Time to First Documented ≥10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score

    EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire

    Measured: From Baseline until treatment discontinuation (up to 78 months)

  7. Time to Confirmed Deterioration in Physical Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score

    Measured: From Baseline until treatment discontinuation (up to 78 months)

  8. Time to Confirmed Deterioration in Role Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score

    Measured: From Baseline until treatment discontinuation (up to 78 months)

  9. Time to Confirmed Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score

    Measured: From Baseline until treatment discontinuation (up to 78 months)

  10. Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)

    Measured: From treatment initiation until 30 days after the final dose of study treatment (up to 78 months)

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

    Vital signs include respiratory rate, pulse rate, and systolic and diastolic blood pressure while the participant is in a seated position, and temperature.

    Measured: Baseline, Days 1 and 15 of Cycles 1 and 2, and Day 1 of each cycle thereafter until treatment discontinuation (1 cycle is 28 days)

  12. Plasma Concentration of Giredestrant at Specified Timepoints

    Measured: Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days)

  13. Plasma Concentration of Palbociclib at Specified Timepoints

    Measured: Days 1 and 15 of Cycle 1 (1 cycle is 28 days)

Timeline

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

  1. First posted11 Sep 2020
  2. Study start9 Oct 2020
  3. Primary completion30 Jan 2026
  4. Study completion31 Jul 2027 (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
Double blind
Who is masked
Participant, Investigator
Enrolment
992 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04546009
Sponsor's protocol ID
BO41843
Other IDs
2020-000119-66, 2023-506911-16-00, 2023
Status last verified
Aug 2026
First submitted
8 Sep 2020
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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, Letrozole and Palbociclib in people with Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer, run by Hoffmann-La Roche at 255 sites in 30 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 9 inclusion and 8 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 255 sites in United States, Japan, Germany, China, South Korea and 25 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), as Determined by the Investigator According to RECIST v1.1 (time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months)). 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 NCT04546009.

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 17 Aug 2026.

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