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)
Running, not enrolling · Phase 2
Conditions studied: Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT04576455
- Run by
- Hoffmann-La Roche
- People needed
- 303
- Starts
- 2020-11-27
- Expected to finish
- 2027-08-25
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Women who are postmenopausal or premenopausal/perimenopausal
- 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
You may not qualify if…
- Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization
- 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
Where it is running
- 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
- Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States
Full record on ClinicalTrials.gov
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