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NCT02107703 · ClinicalTrials.gov registry record · Phase 3
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
A Phase 3 study of Breast Neoplasms, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 669
- Enrollment target
- 20
- Study locations
NCT02107703: Active Phase 3 study of Breast Neoplasms, sponsored by Eli Lilly and Company.
NCT02107703 is a Phase 3 study of Breast Neoplasms that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 669 participants, above the 562-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02107703, a Phase 3 study of Breast Neoplasms, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 669 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.
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)
Florida
- Palm Beach Cancer Institue - Atlantis
- Holy Cross Hospital - Fort Lauderdale
- Florida Cancer Specialists - South - Fort Myers
- Palm Beach Cancer Institue - Palm Beach Gardens
- Florida Cancer Specialists - North - St. Petersburg
- Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center - Tampa
- Palm Beach Cancer Institue - Wellington
- Palm Beach Cancer Institue - West Palm Beach
California
- University of California - San Diego - La Jolla
- Kaiser Permanente - Riverside
- Univ of California San Francisco - San Francisco
- Stanford University Clinic - Stanford
Arkansas
- St. Bernards Medical Center - Jonesboro
- Highlands Oncology Group - Springdale
Georgia
- University Cancer & Blood Center, LLC - Athens
- Harbin Clinic - Rome
Illinois
- Quincy Medical Group - Quincy
Maryland
- Pharmasite Research, Inc. - Baltimore
Massachusetts
- Dana Farber Cancer Institute - Boston
Michigan
- Breslin Cancer Center - Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 669 participants |
| Start Date | 2014-07-22 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What the registry record for NCT02107703 still lists
NCT02107703 is an interventional study that assigns participants to a tested intervention. The registered 669 participants enrollment target is mid-sized for trials with a published cap, above the 562-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02107703 names 20 study sites across 8 states, led by Florida, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT02107703 about?
NCT02107703 is a clinical study titled "A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer". The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abe...
What is the current status of trial NCT02107703?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 669 participants. The study started on 2014-07-22. Estimated completion is 2027-12.
What conditions does trial NCT02107703 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT02107703?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT02107703?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02107703 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
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 NCT02107703's enrollment target sits among peer trials
669 18th of 97 higher than 80 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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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