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NCT05514054 · ClinicalTrials.gov registry record · Phase 3
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
A Phase 3 study of Breast Neoplasms, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 8,000
- Enrollment target
- 20
- Study locations
NCT05514054: Active Phase 3 study of Breast Neoplasms, sponsored by Eli Lilly and Company.
NCT05514054 is a Phase 3 study of Breast Neoplasms that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 8,000 participants, above the 487-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (1543% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05514054, a Phase 3 study of Breast Neoplasms, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 8,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
Primary Outcome
IDFS excluding second non-breast primary invasive cancers
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
- DRUG Imlunestrant
Study Locations (20)
California
- UCSF - John Muir Health Cancer Center Berkeley - Berkeley
- Washington Health - Fremont
- Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine - Irvine
- Loma Linda University Cancer Center - Loma Linda
- Pacific Cancer Care - Monterey
- St. Joseph Hospital - Orange
- University of California, Irvine (UCI) Health - UC Irvine Medical Center - Orange
- University of California Davis (UC Davis) Comprehensive Cancer Center - Sacramento
- Kaiser Permanente San Diego Mission Road - San Diego
- Zuckerberg San Francisco General Hospital and Trauma Center - San Francisco
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- USO - Arizona Oncology Associates - HAL - Glendale
- St. Joseph's Hospital and Medical Center - Phoenix
- Mayo Clinic in Arizona - Phoenix - Phoenix
- TMC HealthCare - Tucson
- The University of Arizona Cancer Center - North Campus - Tucson
Alabama
- USO - Southern Cancer Center - Daphne
- Clearview Cancer Institute - Huntsville
- Infirmary Cancer Care - Mobile
Arkansas
- Highlands Oncology Group - Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,000 participants |
| Start Date | 2022-10-04 |
| Est. Completion | 2032-03 |
| Phase | Phase 3 |
What the registry record for NCT05514054 still lists
NCT05514054 is an interventional study that assigns participants to a tested intervention. Its 8,000 participants enrollment target places it among the larger protocols in the corpus, above the 487-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (1543% higher).
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Tamoxifen is the first listed.
NCT05514054 names 20 study sites across 4 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05514054 about?
NCT05514054 is a clinical study titled "A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer". The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for ...
What is the current status of trial NCT05514054?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 8,000 participants. The study started on 2022-10-04. Estimated completion is 2032-03.
What conditions does trial NCT05514054 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT05514054?
The interventions under investigation include: Tamoxifen (DRUG), Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), Imlunestrant (DRUG).
Who is sponsoring clinical trial NCT05514054?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05514054 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05514054's enrollment target sits among peer trials
8,000 2nd of 97 the highest of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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.
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