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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 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.

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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.

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

FieldValue
Enrollment Target 669 participants
Start Date 2014-07-22
Est. Completion 2027-12
Phase Phase 3

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT02107703

The ClinicalTrials.gov registry entry for NCT02107703 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 669 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 562-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (19% higher). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.