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A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
NCT02107703 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02107703
The ClinicalTrials.gov registry entry for NCT02107703 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 669 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02107703 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02107703?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), Abemaciclib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02107703?
This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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