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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-04-21 |
| Est. Completion | 2024-09-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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