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ACTIVE NOT RECRUITING Phase 2

Abemaciclib and Letrozole to Treat Endometrial Cancer

NCT04393285 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase II single arm trial to determine the percentage of patients without evidence of disease progression on abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer at 6 months. Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.

Conditions Studied

Interventions

  • DRUG Letrozole
  • DRUG Abemaciclib

Study Locations (20)

Florida

  • Sylvester Comprehensive Cancer Center-Lennar Foundation Medical Center — Coral Gables
  • Sylevester Comprehensive Cancer Center-Deerfield Beach — Deerfield Beach
  • UF Health Cancer Center — Gainesville
  • University of Miami - Sylvester Cancer Center — Miami
  • UT Health Tower — Miami
  • Advent Health - Orlando — Orlando
  • Sylvester Comprehensive Cancer Center-Plantation — Plantation
  • Cleveland Clinic Florida — Weston

Connecticut

  • Smillow Cancer Care at Greenwich — Greenwich
  • Yale University — New Haven

Massachusetts

  • Tufts Medical Center — Boston
  • University of Massachusetts — Worcester

New Jersey

  • Rutgers Cancer Institute of New Jersey — New Brunswick
  • Holy Name Medical Center — Teaneck

Alabama

  • University of South Alabama Mitchell Cancer Center — Mobile

Alaska

  • Alaska Women's Cancer Care — Anchorage

Georgia

  • Lewis Cancer & Research Pavilion — Savannah

Illinois

  • University of Chicago — Chicago

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2020-10-10
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

Gynecologic Oncology Group

61 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04393285

The ClinicalTrials.gov registry entry for NCT04393285 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gynecologic Oncology Group, which has 61 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 Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions — of which Letrozole 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: NCT04393285 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Connecticut, Massachusetts. 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 NCT04393285 about?

NCT04393285 is a clinical study titled "Abemaciclib and Letrozole to Treat Endometrial Cancer". This is a phase II single arm trial to determine the percentage of patients without evidence of disease progression on abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer at 6 months. Treatment will continue until either unacceptable toxicity, progres...

What is the current status of trial NCT04393285?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2020-10-10. Estimated completion is 2026-12-31.

What conditions does trial NCT04393285 study?

This clinical trial studies the following conditions: Endometrial Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04393285?

The interventions under investigation include: Letrozole (DRUG), Abemaciclib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04393285?

This trial is sponsored by Gynecologic Oncology Group, which has 61 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04393285 being conducted?

This trial has 20 study locations across Alabama, Alaska, Connecticut, Florida, Georgia. 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