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NCT03155997 · ClinicalTrials.gov registry record · Phase 3
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 5,637
- Enrollment target
- 20
- Study locations
NCT03155997: Active Phase 3 study of Breast Cancer, sponsored by Eli Lilly and Company.
NCT03155997 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 5,637 participants, above the 2,799-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03155997, 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
- 5,637 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Primary Outcome
IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.
Conditions Studied
Interventions
- DRUG Abemaciclib
- DRUG Standard Adjuvant Endocrine Therapy
Study Locations (20)
California
- Beverly Hills Cancer Center - Beverly Hills
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center - Burbank
- City of Hope National Medical Center - Duarte
- California Cancer Associates Research and Excellence - Fresno
- Kaiser Permanente - Harbor City
- Loma Linda University School of Medicine - Loma Linda
- Cedars-Sinai Medical Center - Los Angeles
- Pacific Cancer Care - Monterey
- St. Joseph Hospital - Orange
- University of California Davis (UC Davis) Comprehensive Cancer Center - Sacramento
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Arizona Oncology Associates, P.C. - HOPE - Goodyear
- St. Joseph's Hospital and Medical Center - Phoenix
- Mayo Clinic Hospital - Phoenix
- The University of Arizona Cancer Center - Tucson
- Yuma Regional Cancer Center - Yuma
Arkansas
- St. Bernards Medical Center - Jonesboro
- Highlands Oncology Group - Springdale
Alabama
- University of Alabama Birmingham - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,637 participants |
| Start Date | 2017-07-12 |
| Est. Completion | 2029-05 |
| Phase | Phase 3 |
What the registry record for NCT03155997 still lists
NCT03155997 is an interventional study that assigns participants to a tested intervention. Its 5,637 participants enrollment target places it among the larger protocols in the corpus, above the 2,799-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (101% higher).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Abemaciclib is the first listed.
NCT03155997 names 20 study sites across 5 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT03155997 about?
NCT03155997 is a clinical study titled "Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer". The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
What is the current status of trial NCT03155997?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 5,637 participants. The study started on 2017-07-12. Estimated completion is 2029-05.
What conditions does trial NCT03155997 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03155997?
The interventions under investigation include: Abemaciclib (DRUG), Standard Adjuvant Endocrine Therapy (DRUG).
Who is sponsoring clinical trial NCT03155997?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03155997 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. 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 NCT03155997's enrollment target sits among peer trials
5,637 25th of 1224 higher than 1,200 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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