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NCT02246621 · ClinicalTrials.gov registry record · Phase 3
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 493
- Enrollment target
- 20
- Study locations
NCT02246621: Active Phase 3 study of Breast Cancer, sponsored by Eli Lilly and Company.
NCT02246621 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 493 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02246621, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 493 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.
Primary Outcome
PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by 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 complete baseline disease assessment, then the PFS
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Abemaciclib
Study Locations (20)
California
- CBCC Global Research, Inc. - Bakersfield
- California Cancer Associates Research and Excellence - Fresno
- TRIO-US (Translational Research in Oncology-US) - Los Angeles
- Central Coast Medical Oncology Corporation - Los Angeles
- Orlando Health, Inc - Los Angeles
- North Valley Hematology/Oncology Medical Group - Los Angeles
- UCLA Hematology/Oncology - Parkside - Santa Monica
Florida
- Holy Cross Hospital - Fort Lauderdale
- Lakes Research, LLC - Miami Lakes
Georgia
- Candler Medical Oncology Practice - Statesboro - Savannah
- Candler Medical Oncology Practice - Statesboro - Savannah
Texas
- Oncology Consultants P.A. - Houston
- Joe Arrington Cancer Center - Lubbock
Arizona
- Ironwood Cancer & Research Centers - Chandler
Arkansas
- Highlands Oncology Group - Springdale
Minnesota
- Mayo Clinic in Rochester, Minnesota - Rochester
Nebraska
- Nebraska Hematology-Oncology, P.C. - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 493 participants |
| Start Date | 2014-11-06 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What the registry record for NCT02246621 still lists
NCT02246621 is an interventional study that assigns participants to a tested intervention. The registered 493 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02246621 names 20 study sites across 11 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02246621 about?
NCT02246621 is a clinical study titled "A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer". The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.
What is the current status of trial NCT02246621?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 493 participants. The study started on 2014-11-06. Estimated completion is 2026-12.
What conditions does trial NCT02246621 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02246621?
The interventions under investigation include: Placebo (DRUG), Anastrozole (DRUG), Letrozole (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT02246621?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02246621 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT02246621's enrollment target sits among peer trials
493 204th of 1224 higher than 1,020 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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