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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: Clinical Trial Phase 1 study, sponsored by Criterium.
NCT04791384 is a Phase 1 study that was terminated before completion, run by Criterium. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the safety and tolerability of the abemaciclib and elacestrant combination. We will assess the incidence, nature and severity of all adverse events (AE) that occur on or after C1D1 of therapy, AE severities will be classified using the CTCAE criteria.
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 |
Why NCT04791384 stopped before completion
NCT04791384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Abemaciclib is the first listed.
NCT04791384 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04791384's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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