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A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
Sponsor: Hoffmann-La Roche
Summary
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.
Official title: A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
303
Start Date
2020-11-27
Completion Date
2027-08-25
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
Giredestrant
Giredestrant is taken orally once per day on Days 1-28 of each 28-day cycle.
Fulvestrant or an Aromatase Inhibitor (Physician Choice)
Physician choice of endocrine monotherapy (fulvestrant or an aromatase inhibitor) is taken in accordance with the local prescribing information for the respective product.
LHRH Agonist
Only premenopausal/perimenopausal participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Locations (80)
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States
Northwest Cancer Specialists - Portland (SW Barnes Rd)
Tigard, Oregon, United States
Instituto Angel Roffo
Buenos Aires, Argentina
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, Argentina
Fundación Scherbovsky
Mendoza, Argentina
Hosp Provincial D. Centenarios
Rosario, Argentina
Organizacion Medica de Investigacion
San Nicolás, Argentina
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Pronutrir - suporte nutricional e quimioterapia ltda.
Fortaleza, Ceará, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
The First Hospital of Jilin University
Changchun, China
Sun Yet-sen University Cancer Center
Guangzhou, China
Linyishi Cancer Hospital
Linyi, China
The Third Hospital of Nanchang
Nanchang, China
Fudan University Shanghai Cancer Center
Shanghai, China
Tianjin Cancer Hospital
Tianjin, China
Hubei Cancer Hospital
Wuhan, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, China
Zhejiang Cancer Hospital
Zhejiang, China
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
Aschaffenburg, Germany
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
Berlin, Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, Germany
St. Vincenz-Krankenhaus Paderborn
Paderborn, Germany
Gynäkologie Kompetenzzentrum
Stralsund, Germany
Assuta Medical Center- Ashdod
Ashdod, Israel
Hadassah Ein Karem Hospital
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Bialostockie Centrum Onkologii
Bialystok, Poland
Narodowy Instytut Onkologii Odzia? w Gliwicach
Gliwice, Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
Warsaw, Poland
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky
Krasnoyarsk, Krasnodarskiy Kray, Russia
Petrov Research Inst. of Oncology
Pesochny, Leningrad, Russia
Blokhin Cancer Research Center
Moskva, Moscow Oblast, Russia
Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
Nizhny Novgorod, Niznij Novgorod, Russia
St. Petersburg SHI "City Clinical Oncology Dispensary"
Saint Petersburg, Sankt-Peterburg, Russia
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan', Tatarstan Republic, Russia
Clinical Oncology Centre # 1
Krasnodar, Russia
Multidisciplinary clinic Reaviz
Samara, Russia
Volgograd Regional Clinical Oncology Dispensary
Volgograd, Russia
Regional Clinical Oncology Hospital
Yaroslavl, Russia
National University Hospital
Singapore, Singapore
National Cancer Centre
Singapore, Singapore
Iatros International
Bloemfontein, South Africa
Eastleigh Breast Care Centre
Pretoria, South Africa
Soon Chun Hyang University Cheonan Hospital
Dongnam-gu, Cheonan-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul St Mary's Hospital
Seoul, South Korea
Changhua Christian Hospital
Changhua, Taiwan
National Cheng Kung Uni Hospital
Tainan, Taiwan
Chi-Mei Medical Centre
Tainan, Taiwan
Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hosipital at Linkou
Taoyuan Hsien, Taiwan
Chulalongkorn Hospital
Bangkok, Thailand
Rajavithi Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hosp
Chang Mai, Thailand
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Memorial Antalya Hospital
Antalya, Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, Turkey (Türkiye)
Kartal Dr Lutfi Kirdar Sehir Hastanesi
Istanbul, Turkey (Türkiye)
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, Turkey (Türkiye)
Izmir Ataturk Training and Research Hospital
Izmir, Turkey (Türkiye)
Medikal Park Samsun
Samsun, Turkey (Türkiye)
Zhytomyr Regional Oncology Center
Zhytomyr, KIEV Governorate, Ukraine
Kyiv City Clinical Oncological Center
Kyiv, Ukraine
MI Kyiv Regional Council Kyiv Regional Oncological Dispensary
Kyiv, Ukraine
RCI Sumy Regional Clinical Oncological Dispensary
Sumy, Ukraine
Princess Alexandra Hospital
Harlow, United Kingdom
Guys & St Thomas Hospital
London, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
Peterborough City Hospital
Peterborough, United Kingdom