Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

NCT05169567 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.

Interventions

  • DRUG Placebo
  • DRUG Fulvestrant
  • DRUG Abemaciclib

Study Locations (20)

California

  • Providence Medical Foundation — Fullerton
  • Cancer and Blood Specialty Clinic — Los Alamitos
  • TRIO-US (Translational Research in Oncology-US) — Los Angeles
  • Keck School of Medicine of USC — Los Angeles
  • UCLA Hematology/Oncology - Parkside — Santa Monica
  • Olive View-UCLA Medical Center — Sylmar
  • Torrance Memorial Physician Network / Cancer Care — Torrance
  • PIH Health Hematology Medical Oncology — Whittier

Florida

  • Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI — Fort Myers
  • Millennium Oncology Research Clinic — Hollywood
  • University of Miami Hospital and Clinics, Sylvester Cancer Center — Miami
  • Woodlands Medical Specialists, PA — Pensacola
  • Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI — Sarasota
  • Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI — West Palm Beach

Georgia

  • Winship Cancer Institute, Emory University — Atlanta
  • Northeast Georgia Medical Center — Gainesville
  • Central Georgia Cancer Care — Macon

Arizona

  • St. Joseph's Hospital and Medical Center — Phoenix

Arkansas

  • Highlands Oncology Group — Springdale

Colorado

  • Rocky Mountain Cancer Center - Hale Parkway — Denver

Trial Details

FieldValue
Enrollment Target 368 participants
Start Date 2022-03-11
Est. Completion 2027-12
Phase Phase 3

Sponsor

Eli Lilly and Company

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05169567

The ClinicalTrials.gov registry entry for NCT05169567 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 368 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 2 conditions, with Neoplasm Metastasis 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: NCT05169567 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Georgia. 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 NCT05169567 about?

NCT05169567 is a clinical study titled "Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer". This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor ...

What is the current status of trial NCT05169567?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 368 participants. The study started on 2022-03-11. Estimated completion is 2027-12.

What conditions does trial NCT05169567 study?

This clinical trial studies the following conditions: Neoplasm Metastasis, Breast Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05169567?

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 NCT05169567?

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 NCT05169567 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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