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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: Active Phase 3 study of Neoplasm Metastasis and Breast Neoplasm, sponsored by Eli Lilly and Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was 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 progression of non-target lesions, or 1 or more new lesions. If a participant does not have a com
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 |
What the registry record for NCT05169567 still lists
NCT05169567 is an interventional study that assigns participants to a tested intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap, below the 407-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (10% lower).
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 names 20 study sites across 6 states, led by 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.
Learn More About Clinical Trials
Similar trials for Neoplasm Metastasis
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 NCT05169567's enrollment target sits among peer trials
368 14th of 41 higher than 28 of 41 other Neoplasm Metastasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasm Metastasis 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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