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NCT04576455 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 2
- Development phase
- 303
- Enrollment target
- 20
- Study locations
NCT04576455 is a Phase 2 study of Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 303 participants. The trial reports 20 study locations across 9 states.
The verdict
NCT04576455, a Phase 2 study of Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 303 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Giredestrant
- DRUG LHRH Agonist
- DRUG Fulvestrant or an Aromatase Inhibitor (Physician Choice)
Study Locations (20)
Other
- Instituto Angel Roffo - Buenos Aires
- Fundación CENIT para la Investigación en Neurociencias - Buenos Aires
- Fundación Scherbovsky - Mendoza
- Hosp Provincial D. Centenarios - Rosario
- Organizacion Medica de Investigacion - San Nicolás
- The First Hospital of Jilin University - Changchun
- Sun Yet-sen University Cancer Center - Guangzhou
- Linyishi Cancer Hospital - Linyi
- The Third Hospital of Nanchang - Nanchang
- Fudan University Shanghai Cancer Center - Shanghai
- Tianjin Cancer Hospital - Tianjin
Rio Grande do Sul
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda - Ijuí
- Santa Casa de Misericordia de Porto Alegre - Porto Alegre
Georgia
- Northwest Georgia Oncology Centers PC - Marietta - Marietta
Ohio
- University Hospitals Seidman Cancer Center - Cleveland
Oregon
- Northwest Cancer Specialists - Portland (SW Barnes Rd) - Tigard
New South Wales
- Kinghorn Cancer Centre - Darlinghurst
Victoria
- Sunshine Hospital - St Albans
Ceará
- Pronutrir - suporte nutricional e quimioterapia ltda. - Fortaleza
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2020-11-27 |
| Est. Completion | 2027-08-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04576455
The ClinicalTrials.gov registry entry for NCT04576455 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 303 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Giredestrant is the first listed.
NCT04576455 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Rio Grande do Sul, Georgia.
Frequently Asked Questions
What is clinical trial NCT04576455 about?
NCT04576455 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT04576455?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 303 participants. The study started on 2020-11-27. Estimated completion is 2027-08-25.
What conditions does trial NCT04576455 study?
This clinical trial studies the following conditions: Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer.
What interventions are being tested in trial NCT04576455?
The interventions under investigation include: Giredestrant (DRUG), LHRH Agonist (DRUG), Fulvestrant or an Aromatase Inhibitor (Physician Choice) (DRUG).
Who is sponsoring clinical trial NCT04576455?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04576455 being conducted?
This trial has 20 study locations across Georgia, Ohio, Oregon, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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