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)

May 18, 2026 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
992

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Hospital de Onc Angel Roffo
      • Cap Fed, Argentina, 1015
        • Organización medica de Investi
      • Ciudad Autonoma Bs As, Argentina, C1280AEB
        • Hospital Britanico
      • Rosario, Argentina, S2000KZE
        • Instituto de Oncología de Rosario
      • Vicente López, Argentina, B1602DQD
        • Cemer Centro Medico de Enfermedades Respiratorias
    • Ciudad Autónoma de BuenosAires
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1113AAE
        • Centro de Investigaciones Médicas y Desarrollo LC S.R.L
  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Hospital Brisbane
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre-East Melbourne
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital - Medical Oncology
  • Austria
      • Salzburg, Austria, 5020
        • Uniklinikum Salzburg, LKH
      • Steyr, Austria, 4400
        • A.Ö. LHK
      • Vienna, Austria, 1090
        • Medizinische Universität Wien
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Hasselt, Belgium, 3500
        • Jessa Zkh (Campus Virga Jesse)
  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41253-190
        • Hospital Sao Rafael - HSR
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-070
        • Hospital Araujo Jorge
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Hospital do Cancer de Pernambuco - HCP
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
      • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
        • Santa Casa de Misericordia de Porto Alegre
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Hospital de Base de Sao Jose do Rio Preto
      • São Paulo, São Paulo, Brazil, 01323-900
        • Beneficencia Portuguesa de Sao Paulo
      • São Paulo, São Paulo, Brazil, 01317-000
        • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J.E. Child Comprehensive Cancer Center-Calgary
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BC Cancer ? Surrey
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Regional Health Centre
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System Brampton Civic Hospital
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital Research Institute
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Center
      • Montreal, Quebec, Canada, H1T 2M4
        • Universite de Montreal - Hopital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l?Université de Montréal (CHUM)
      • Québec, Quebec, Canada, G1S 4L8
        • Hopital du Saint Sacrement
  • China
      • Anyang, China, 455000
        • Anyang Tumor Hosptial
      • Baoding, China, 071000
        • Affiliated Hospital of Hebei University
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Bengbu, China, 233000
        • The First Affiliated Hospital of Bengbu Medical College
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Changsha, China, 410013
        • Hunan Cancer Hospital
      • Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Guangzhou, China, 510000
        • Sun Yat-sen Memorial Hospital
      • Guangzhou, China, 510060
        • Sun Yet-sen University Cancer Center
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Jinan, China, 250117
        • Shandong Cancer Hospital
      • Nanning, China, 530021
        • Guangxi Cancer Hospital of Guangxi Medical University
      • Shenyang, China, 110042
        • Liaoning cancer Hospital & Institute
      • Shenyang, China, 110004
        • Shengjing Hospital of China Medical University
      • Xi'an, China, 710061
        • The First Affiliated Hospital of Xian Jiao Tong University
  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Næstved, Denmark, 4700
        • Sjællands Universitetshospital, Næstved
      • Odense C, Denmark, 5000
        • Odense Universitetshospital, Onkologisk Afdeling R
  • France
      • Angers, France, 49055
        • ICO Paul Papin
      • Bayonne, France, 64109
        • Centre Hospitalier de la Cote Basque
      • La Roche-sur-Yon, France, 85925
        • CHD de Vendée
      • Montpellier, France, 34298
        • Institut regional du Cancer Montpellier
      • Poitiers, France, 86021
        • CHU La Miletrie
      • Reims, France, 51056
        • Institut Jean Godinot
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Saint-Priest-en-Jarez, France, 42271
        • ICL
      • Vandœuvre-lès-Nancy, France, 54511
        • Centre Alexis Vautrin
  • Germany
      • Berlin, Germany, 13581
        • Ambulantes Tumorzentrum Spandau
      • Chemnitz, Germany, 09116
        • Klinikum Chemnitz gGmbH
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Georgsmarienhütte, Germany, 49124
        • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
      • Göttingen, Germany, 37073
        • Dres.Andreas Ammon und Dirk Meyer
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Hamburg, Germany, 20249
        • Facharztzentrum Eppendorf, Studien GbR
      • Hanover, Germany, 30625
        • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
      • Heidelberg, Germany, 69120
        • Nationales Centrum für Tumorerkrankungen (NCT)
      • Koblenz, Germany, 56068
        • Praxis Köppler, Heymann, Weide, Thomalla
      • Langen, Germany, 63225
        • Dres. Andreas Köhler und Roswitha Fuchs
      • Leipzig, Germany, 04277
        • St. Elisabeth-Krankenhaus, Senologie/Brustzentrum
      • Mannheim, Germany, 68167
        • Universitätsklinikum Mannheim
      • München, Germany, 80336
        • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
      • Ravensburg, Germany, 88212
        • MVZ für Hämatologie und Onkologie Ravensburg GmbH
      • Trier, Germany, 54290
        • Klinikum Mutterhaus der Borromaeerinnen gGmbH
      • Troisdorf, Germany, 53840
        • Dres. Helmut Forstbauer, Carsten Ziske und Kollegen
      • Tübingen, Germany, 72076
        • Universitätsklinik Tübingen
  • Greece
      • Athens, Greece, 115 22
        • Anticancer Hospital Ag Savas
      • Athens, Greece, 115 22
        • Anticancer Hospital Ag. Savas
      • Thessaloniki, Greece, 570 01
        • European Interbalkan Medical Center
      • Thessaloniki, Greece, 546450
        • Euromedical General Clinic of Thessaloniki
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital
  • Hungary
      • Budapest, Hungary, 1145
        • Budapesti Uzsoki Utcai Kórház
      • Budapest, Hungary, 1062
        • Honvédelmi Minisztérium Állami Egészségügyi Központ;Onkológiai Osztály
  • Israel
      • Petah Tikva, Israel, 49100
        • Davidof Center - Rabin Medical Center
      • Ramat Gan, Israel, 52620-00
        • Chaim Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Ctr
  • Italy
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
    • Lazio
      • Rome, Lazio, Italy, 00144
        • IRCCS Istituto Regina Elena (IFO)
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Az. Osp. Spedali Civili
      • Milan, Lombardy, Italy, 20141
        • Istituto Europeo di Oncologia
      • Monza, Lombardy, Italy, 20900
        • Asst Di Monza
    • Sicily
      • Misterbianco (CT), Sicily, Italy, 95045
        • Humanitas Centro Catanese Di Oncologia
    • Trentino-Alto Adige
      • Candiolo, Trentino-Alto Adige, Italy, 10060
        • Fondazione del Piemonte per l?Oncologia (IRCCS)
    • Tuscany
      • Livorno, Tuscany, Italy, 57124
        • Ospedale Civile - Livorno
    • Veneto
      • Negrar, Veneto, Italy, 37024
        • Ospedale Sacro Cuore Don Calabria
      • Padova, Veneto, Italy, 35128
        • IOV - Istituto Oncologico Veneto - IRCCS
      • Vicenza, Veneto, Italy, 36100
        • Azienda ULSS 8 Berica
  • Japan
      • Aichi, Japan, 466-8560
        • Nagoya University Hospital
      • Chiba, Japan, 260-8717
        • Chiba cancer center
      • Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
      • Hyōgo, Japan, 673-0021
        • Hyogo Cancer Center
      • Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital
      • Kagoshima, Japan, 892-0833
        • Sagara Hospital
      • Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
      • Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Miyagi, Japan, 960-1295
        • Fukushima Medical University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Okinawa, Japan, 901-0154
        • Naha-nishi Clinic
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
      • Tokyo, Japan, 142-8666
        • Showa Medical University Hospital
  • Mexico
      • Morelia, Mexico, 58260
        • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
      • Veracruz, Mexico, 91900
        • Sociedad de Metabolismo y Corazón (SOMECO)
    • Mexico CITY (federal District)
      • CD Mexico, Mexico CITY (federal District), Mexico, 03810
        • Health Pharma Professional Research
      • Mexico City, Mexico CITY (federal District), Mexico, 06760
        • Centro de Atencion Oncologica Viva S de RL de CV
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Filios Alta Medicina
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Centro de Investigacion Clinica de Oaxaca
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78209
        • Oncologico Potosino
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
  • Peru
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas
      • Lima, Peru, 41
        • Oncosalud Sac
      • Lima, Peru, Lima 27
        • Instituto Peruano de Oncología y Radioterapia
      • Trujillo, Peru, 13014
        • Instituto Regional de Enfermedades Neoplasicas - IREN Norte
  • Poland
      • Gda?sk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gdynia, Poland, 81-519
        • Szpital Morski Im. Pck
      • Warsaw, Poland, 02-781
        • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
  • Portugal
      • Coimbra, Portugal, 3000-075
        • IPO de Coimbra
      • Lisbon, Portugal
        • Centro Hospitalar Lisboa Norte
      • Lisbon, Portugal, 1500-650
        • Hospital da Luz
      • Porto, Portugal, 4200-072
        • IPO do Porto
  • Russia
      • Chelyabinsk, Russia, 454087
        • Chelyabinsk region oncology dispensary
      • Samara, Russia, 443011
        • Multidisciplinary clinic Reaviz
      • Yaroslavl, Russia, 150040
        • Regional Clinical Oncology Hospital
    • Moscow Oblast
      • Moskva, Moscow Oblast, Russia, 111123
        • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
      • Podolsk, Moscow Oblast, Russia, 142100
        • Podolsk City Clinical Hospital
    • Respublika Mordoviya
      • Saransk, Respublika Mordoviya, Russia, 430032
        • Respublikanskiy Onkologicheskiy Dispanser
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Russia, 390011
        • Ryazan Regional clinical oncology dispensary
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
  • South Korea
      • Cheongju-si, South Korea, 28644
        • Chungbuk National University Hospital
      • Daegu, South Korea, 41944
        • Kyungpook National University Medical Center
      • Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, South Korea, 10408
        • National Cancer Center
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital
      • Seoul, South Korea, 8308
        • Korea University Guro Hospital
      • Ulsan, South Korea, 44033
        • Ulsan University Hosiptal
  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC)
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08028
        • Hospital Universitari Dexeus - Grupo Quironsalud
      • Barcelona, Spain, 08035
        • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28050
        • HM Sanchinarro ? CIOCC
      • Madrid, Spain, 28033
        • Centro Oncologico MD Anderson Internacional
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Duran i Reynals
      • Sabadell, Barcelona, Spain, 8208
        • Corporacio Sanitaria Parc Tauli
    • Guipuzcoa
      • Donostia / San Sebastian, Guipuzcoa, Spain, 20080
        • Hospital de Donostia
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Quiron de Madrid
  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung Uni Hospital
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital
      • Taipei, Taiwan, 00112
        • Veterans General Hospital
      • Taoyuan Hsien, Taiwan, 333
        • Chang Gung Memorial Hosipital at Linkou
  • Thailand
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi hospital
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital, Faculty of Medicine
      • Chang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hosp
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06490
        • Ankara Bilkent City Hospital
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe Uni Medical Faculty Hospital
      • Edirne, Turkey (Türkiye), 22030
        • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
      • Istanbul, Turkey (Türkiye), 34730
        • Medeniyet University Goztepe Training and Research Hospital.
      • Istanbul, Turkey (Türkiye), 34214
        • Medipol University Medical Faculty
      • Izmir, Turkey (Türkiye), 35360
        • Izmir Ataturk Training and Research Hospital
      • Malatya, Turkey (Türkiye), 44280
        • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
      • Samsun, Turkey (Türkiye), 55139
        • 19 Mayis University Medical Faculty
      • İzmit, Turkey (Türkiye), 31380
        • Kocaeli University Faculty of Medicine
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76018
        • Ivano-Frankivsk Regional Oncology Center
      • Kryvyi Rih, Ukraine, 50048
        • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
      • Sumy, Ukraine, 40005
        • Sumy Regional Clinical Onc Ctr
    • Katerynoslav Governorate
      • Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
        • Municipal Institution City Clinical Hospital #4 of Dnipro City Council
    • Kharkiv Governorate
      • Kharkiv, Kharkiv Governorate, Ukraine, 61018
        • SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, NW1 - 2PG
        • University College London Hospital
      • London, United Kingdom, NW3 2QS
        • Royal Free Hospital
      • London, United Kingdom, SE1 9RT
        • Guys & St Thomas Hospital
      • Maidstone, United Kingdom, ME16 0FS
        • Maidstone Hospital
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough City Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hosp NHS Fnd
      • Truro, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Orange Coast Memorial Medical Center
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • San Leandro, California, United States, 94577
        • Kaiser Permanente - San Leandro Medical Center
      • Stanford, California, United States, 94305
        • Stanford Univ Medical Center
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente - Walnut Creek
    • Colorado
      • Aurora, Colorado, United States, 80045-2517
        • University of Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists - Fort Myers (Broadway)
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Cancer Ctr
      • Miami, Florida, United States, 33136
        • University of Miami
      • St. Petersburg, Florida, United States, 33705
        • SCRI Florida Cancer Specialists North
      • Tallahassee, Florida, United States, 32308
        • SCRI Florida Cancer Specialists PAN
    • Hawaii
      • Honolulu, Hawaii, United States, 96819-1469
        • Kaiser Permanente - Moanalua Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Silver Spring, Maryland, United States, 20902
        • Maryland Oncology Hematology
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • HCA Midwest Division
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Cancer Center Basking Ridge
      • East Brunswick, New Jersey, United States, 08816
        • Astera Cancer Care East Brunswick
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Cancer Center at Bergen
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • New York
      • Commack, New York, United States, 11725
        • MSKCC @ Commack
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Ctr
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Roper St. Francis Healthcare
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • West Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute / Tennessee Oncology
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology - DFW
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders - Fort Worth
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • Baylor St. Luke's Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Giredestrant + Letrozole-matched Placebo + Palbociclib
Drug: Giredestrant
Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
Other Names:
  • GDC-9545
  • RO7197597
  • RG6171
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.
Active Comparator: Letrozole + Giredestrant-matched Placebo + Palbociclib
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomization to death from any cause (up to 78 months)
From randomization to death from any cause (up to 78 months)
Objective Response Rate, as Determined by the Investigator According to RECIST v1.1
Time Frame: From randomization until disease progression or death (up to 78 months)
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.
From randomization until disease progression or death (up to 78 months)
Duration of Response, as Determined by the Investigator According to RECIST v1.1
Time Frame: From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months)
From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months)
Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1
Time Frame: From randomization until disease progression or death (up to 78 months)
The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response or partial response.
From randomization until disease progression or death (up to 78 months)
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)
Time Frame: From treatment initiation until 30 days after the final dose of study treatment (up to 78 months)
From treatment initiation until 30 days after the final dose of study treatment (up to 78 months)
Number of Participants with Vital Sign Abnormalities Over the Course of the Study
Time Frame: 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)
Vital signs include respiratory rate, pulse rate, and systolic and diastolic blood pressure while the participant is in a seated position, and temperature.
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)
Plasma Concentration of Giredestrant at Specified Timepoints
Time Frame: Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days)
Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days)
Plasma Concentration of Palbociclib at Specified Timepoints
Time Frame: Days 1 and 15 of Cycle 1 (1 cycle is 28 days)
Days 1 and 15 of Cycle 1 (1 cycle is 28 days)
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
Time Frame: From Baseline until treatment discontinuation (up to 78 months)
From Baseline until treatment discontinuation (up to 78 months)
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
Time Frame: From Baseline until treatment discontinuation (up to 78 months)
EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire
From Baseline until treatment discontinuation (up to 78 months)
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
Time Frame: From Baseline until treatment discontinuation (up to 78 months)
From Baseline until treatment discontinuation (up to 78 months)
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
Time Frame: From Baseline until treatment discontinuation (up to 78 months)
From Baseline until treatment discontinuation (up to 78 months)
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
Time Frame: From Baseline until treatment discontinuation (up to 78 months)
From Baseline until treatment discontinuation (up to 78 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BO41843
  • 2020-000119-66 (EudraCT Number)
  • 2023-506911-16-00 (Ctis: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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