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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: Active Phase 2 study of Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer, sponsored by Hoffmann-La Roche.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (128% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was defined as the Kaplan-Meier estimate of time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first). Disease progression was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. Kaplan-Meier methodology was used to estimate median PFS. The 95% confidence interval for the medi
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 |
What the registry record for NCT04576455 still lists
NCT04576455 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (128% higher).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
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Where NCT04576455's enrollment target sits among peer trials
303 167th of 2000 higher than 1,834 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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