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NCT04791384 · ClinicalTrials.gov registry record · Phase 1

Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

A Phase 1 study, sponsored by Criterium.

Terminated
Registry status
Phase 1
Development phase
5
Enrollment target

NCT04791384 is a Phase 1 study that was terminated before completion, run by Criterium. The registered enrollment target is 5 participants.

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The verdict

NCT04791384, a Phase 1 study, was terminated before completion, sponsored by Criterium.

TERMINATED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

This is a multi-institutional, single arm, open label, Phase Ib/II study of abemaciclib in combination with elacestrant in patients with HR+/Her2- breast cancer metastatic to the brain. Patients may have received up to two prior lines of systemic chemotherapy for locally advanced or metastatic disease. There will be no limit on prior use of endocrine therapy including aromatase inhibitors, tamoxifen and fulvestrant, given a documented clinical benefit of elacestrant in this setting.

Interventions

  • DRUG Abemaciclib
  • DRUG Elacestrant

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2022-04-21
Est. Completion 2024-09-17
Phase Phase 1

Sponsor

Criterium

11 total trials

What the Registry Record Tells You About NCT04791384

The ClinicalTrials.gov registry entry for NCT04791384 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Criterium, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Abemaciclib is the first listed.

NCT04791384 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04791384 about?

NCT04791384 is a clinical study titled "Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer". This is a multi-institutional, single arm, open label, Phase Ib/II study of abemaciclib in combination with elacestrant in patients with HR+/Her2- breast cancer metastatic to the brain. Patients may have received up to two prior lines of systemic chemotherapy for locally advanced or metastatic disea...

What is the current status of trial NCT04791384?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2022-04-21. Estimated completion is 2024-09-17.

What interventions are being tested in trial NCT04791384?

The interventions under investigation include: Abemaciclib (DRUG), Elacestrant (DRUG).

Who is sponsoring clinical trial NCT04791384?

This trial is sponsored by Criterium, which has 11 total clinical trials registered on ClinicalTrials.gov.

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.