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RECRUITING Phase 4

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

NCT06169371 · View on ClinicalTrials.gov ↗

Study Summary

This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers

Conditions Studied

Interventions

  • DRUG Abemaciclib

Study Locations (3)

Illinois

  • University of Illinois — Chicago

Iowa

  • Iowa Holden Comprehensive Cancer Center — Iowa City

Ohio

  • Ohio State University Comprehensive Cancer Center — Columbus

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-12-28
Est. Completion 2030-11
Phase Phase 4

Sponsor

University of Illinois at Chicago

421 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06169371

The ClinicalTrials.gov registry entry for NCT06169371 describes a study currently listed as recruiting. It is categorized as Phase 4, 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 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 421 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 Cancer appearing as the primary indexed condition, and to 1 intervention — of which Abemaciclib 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: NCT06169371 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Illinois, Iowa, Ohio. 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 NCT06169371 about?

NCT06169371 is a clinical study titled "Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)". This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of...

What is the current status of trial NCT06169371?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2023-12-28. Estimated completion is 2030-11.

What conditions does trial NCT06169371 study?

This clinical trial studies the following conditions: Breast 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 NCT06169371?

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

Who is sponsoring clinical trial NCT06169371?

This trial is sponsored by University of Illinois at Chicago, which has 421 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06169371 being conducted?

This trial has 3 study locations across Illinois, Iowa, Ohio. 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