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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: Active Phase 3 study of Breast Neoplasms and Neoplasm Metastasis, sponsored by Eli Lilly and Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progressi
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 |
What the registry record for NCT04975308 still lists
NCT04975308 is an interventional study that assigns participants to a tested intervention. The registered 874 participants enrollment target is mid-sized for trials with a published cap, above the 560-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (56% higher).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
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Where NCT04975308's enrollment target sits among peer trials
874 15th of 97 higher than 83 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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