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)
NCT ID: NCT04576455
Last Updated: 2026-01-16
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
303 participants
INTERVENTIONAL
2020-11-27
2027-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Giredestrant
Giredestrant
Giredestrant is taken orally once per day on Days 1-28 of each 28-day cycle.
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.
Physician Choice of Endocrine Monotherapy
The physician choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment
* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented ER-positive tumor and HER2-negative tumor, assessed locally
* Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting
* 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 (ECOG) Performance Status 0-1
* Adequate organ function
Exclusion Criteria
* Treatment with any investigational therapy within 28 days prior to randomization
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Active cardiac disease or history of cardiac dysfunction
* Pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Núcleo de Pesquisa São Camilo
São Paulo, São Paulo, Brazil
The First Hospital of Jilin University
Changchun, , China
Sun Yet-sen University Cancer Center
Guangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , 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
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth, , South Africa
Eastleigh Breast Care Centre
Pretoria, , South Africa
Soon Chun Hyang University Cheonan Hospital
Dongnam-gu, Cheonan-si, , South Korea
National Cancer Center
Goyang-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
Songklanagarind Hospital
Songkhla, , 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)
Katip Celebi University 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
Countries
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References
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Malhi V, Nowicka M, Chen YC, Agarwal P, Waldvogel M, Lien YTK, Hafner M, Perez-Moreno P, Moore HM, Yu J. UGT1A4 Polymorphism is not Associated with a Clinically Relevant Change in Giredestrant Exposure. Cancer Chemother Pharmacol. 2024 Jul;94(1):117-122. doi: 10.1007/s00280-023-04634-4. Epub 2024 Feb 2.
Martin M, Lim E, Chavez-MacGregor M, Bardia A, Wu J, Zhang Q, Nowecki Z, Cruz FM, Safin R, Kim SB, Schem C, Montero AJ, Khan S, Bandyopadhyay R, Moore HM, Shivhare M, Patre M, Martinalbo J, Roncoroni L, Perez-Moreno PD, Sohn J; acelERA Breast Cancer Study Investigators. Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study. J Clin Oncol. 2024 Jun 20;42(18):2149-2160. doi: 10.1200/JCO.23.01500. Epub 2024 Mar 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-001984-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WO42312
Identifier Type: -
Identifier Source: org_study_id
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