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NCT05169567 · ClinicalTrials.gov registry record · Phase 3
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
A Phase 3 study of Neoplasm Metastasis and Breast Neoplasm, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 368
- Enrollment target
- 20
- Study locations
NCT05169567 is a Phase 3 study of Neoplasm Metastasis and Breast Neoplasm that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 368 participants, below the 407-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT05169567, a Phase 3 study of Neoplasm Metastasis and Breast Neoplasm, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 368 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fulvestrant
- DRUG Abemaciclib
Study Locations (20)
California
- Providence Medical Foundation - Fullerton
- Cancer and Blood Specialty Clinic - Los Alamitos
- TRIO-US (Translational Research in Oncology-US) - Los Angeles
- Keck School of Medicine of USC - Los Angeles
- UCLA Hematology/Oncology - Parkside - Santa Monica
- Olive View-UCLA Medical Center - Sylmar
- Torrance Memorial Physician Network / Cancer Care - Torrance
- PIH Health Hematology Medical Oncology - Whittier
Florida
- Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI - Fort Myers
- Millennium Oncology Research Clinic - Hollywood
- University of Miami Hospital and Clinics, Sylvester Cancer Center - Miami
- Woodlands Medical Specialists, PA - Pensacola
- Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI - Sarasota
- Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI - West Palm Beach
Georgia
- Winship Cancer Institute, Emory University - Atlanta
- Northeast Georgia Medical Center - Gainesville
- Central Georgia Cancer Care - Macon
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Arkansas
- Highlands Oncology Group - Springdale
Colorado
- Rocky Mountain Cancer Center - Hale Parkway - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05169567
The ClinicalTrials.gov registry entry for NCT05169567 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 368 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 407-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (10% lower). 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 Neoplasm Metastasis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05169567 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05169567 about?
NCT05169567 is a clinical study titled "Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer". This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor ...
What is the current status of trial NCT05169567?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 368 participants. The study started on 2022-03-11. Estimated completion is 2027-12.
What conditions does trial NCT05169567 study?
This clinical trial studies the following conditions: Neoplasm Metastasis, Breast Neoplasm.
What interventions are being tested in trial NCT05169567?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT05169567?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05169567 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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.