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NCT04975308 · ClinicalTrials.gov registry record · Phase 3
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
A Phase 3 study of Breast Neoplasms and Neoplasm Metastasis, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 874
- Enrollment target
- 20
- Study locations
NCT04975308 is a Phase 3 study of Breast Neoplasms and Neoplasm Metastasis that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 874 participants, above the 560-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT04975308, a Phase 3 study of Breast Neoplasms and Neoplasm Metastasis, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 874 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, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
Conditions Studied
Interventions
- DRUG Exemestane
- DRUG Fulvestrant
- DRUG Abemaciclib
- DRUG Imlunestrant
Study Locations (20)
Florida
- Clermont Oncology Center - Clermont
- University of Florida College of Medicine - Gainesville
- Mid Florida Hematology and Oncology Center - Orange City
- Florida Cancer Specialists - Sarasota
- Florida Cancer Specialists - St. Petersburg
California
- Marin Cancer Care - Greenbrae
- University of California Davis (UC Davis) Comprehensive Cancer Center - Sacramento
- Sharp Memorial Hospital - San Diego
Arizona
- Ironwood Cancer & Research Centers - Chandler
- Banner MD Anderson Cancer Center - Gilbert
Illinois
- University of Chicago Medical Center - Chicago
- NorthShore University HealthSystem - Evanston Hospital - Evanston
New Jersey
- Care Access - Clifton - Clifton
- Memorial Sloan Kettering - Bergen - Montvale
Colorado
- Banner MD Anderson Cancer Center at McKee Medical Center - Loveland
Hawaii
- Kaiser Permanente Moanalua Medical Center - Honolulu
Indiana
- IU Health Ball Memorial Hospital, Inc. - Muncie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 874 participants |
| Start Date | 2021-10-04 |
| Est. Completion | 2027-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04975308
The ClinicalTrials.gov registry entry for NCT04975308 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 874 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 560-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (56% higher). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Exemestane is the first listed.
NCT04975308 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04975308 about?
NCT04975308 is a clinical study titled "A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer". The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative ...
What is the current status of trial NCT04975308?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 874 participants. The study started on 2021-10-04. Estimated completion is 2027-08.
What conditions does trial NCT04975308 study?
This clinical trial studies the following conditions: Breast Neoplasms, Neoplasm Metastasis.
What interventions are being tested in trial NCT04975308?
The interventions under investigation include: Exemestane (DRUG), Fulvestrant (DRUG), Abemaciclib (DRUG), Imlunestrant (DRUG).
Who is sponsoring clinical trial NCT04975308?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04975308 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.