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NCT02747004 · ClinicalTrials.gov registry record · Phase 2
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
A Phase 2 study of Metastatic Breast Cancer, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 2
- Development phase
- 234
- Enrollment target
- 20
- Study locations
NCT02747004: Active Phase 2 study of Metastatic Breast Cancer, sponsored by Eli Lilly and Company.
NCT02747004 is a Phase 2 study of Metastatic Breast Cancer that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 234 participants, above the 203-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02747004, a Phase 2 study of Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 234 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
Primary Outcome
Progression-free survival time was measured from the date of randomization to the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause, whichever occurred first. Progressive disease (PD) is 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 progression of non-target lesions, or 1 or more new lesions. Participan
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG Abemaciclib
- DRUG Prophylactic Loperamide
Study Locations (20)
Other
- Sanatorio Parque - Salta
- AKH - Vienna
- Grand Hopital de Charleroi-Site Notre-Dame - Charleroi
- Centre Hospitalier Universitaire Sart Tilman - Liège
Oost-Vlaanderen
- Universitair Ziekenhuis Gent - Ghent
- VITAZ - Sint-Niklaas
Arizona
- The University of Arizona Cancer Center - Tucson
New Hampshire
- Dartmouth Hitchcock Medical Center - Lebanon
Tennessee
- Tennessee Oncology PLLC - Nashville
Texas
- The Center for Cancer and Blood Disorders - Fort Worth
Wisconsin
- University of Wisconsin Clinical Research Center - Madison
Buenos Aires
- CENIT Centro de Neurociencias, Investigación y Tratamiento - CABA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2016-09-14 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT02747004 still lists
NCT02747004 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, above the 203-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (15% higher).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Tamoxifen is the first listed.
NCT02747004 names 20 study sites across 16 states, led by Other, Oost-Vlaanderen, Arizona.
Frequently Asked Questions
What is clinical trial NCT02747004 about?
NCT02747004 is a clinical study titled "A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer". The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
What is the current status of trial NCT02747004?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 234 participants. The study started on 2016-09-14. Estimated completion is 2026-12.
What conditions does trial NCT02747004 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT02747004?
The interventions under investigation include: Tamoxifen (DRUG), Abemaciclib (DRUG), Prophylactic Loperamide (DRUG).
Who is sponsoring clinical trial NCT02747004?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02747004 being conducted?
This trial has 20 study locations across Arizona, New Hampshire, Tennessee, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02747004's enrollment target sits among peer trials
234 25th of 139 higher than 115 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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